Trial Outcomes & Findings for Rituximab + Immunotherapy in Follicular Lymphoma (NCT NCT03636503)
NCT ID: NCT03636503
Last Updated: 2025-02-06
Results Overview
Patients assessed for DLT after each 28-day cycle of treatment. Up to two cohorts of 3 patients per dose level plus expansion cohort. Rituximab/Utomilumab/Avelumab arm assessed 2 dose levels. Rituximab/Utomilumab/PF04518600 assessed 3 dose levels. Rituximab/PF04518600/Avelumab assessed 2 dose levels.
TERMINATED
PHASE1
24 participants
6 months total, assessed after each 28-day cycle
2025-02-06
Participant Flow
The study was terminated early due to the drug manufacturer stopping drug supply.
Participant milestones
| Measure |
Rituximab+Utomilumab+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+Utomilumab+Avelumab-10mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
PF04518600-0.3mg
-PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg
* Rituximab is administered intravenously per institutional standards
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+Utomilumab+PF04518600-0.3mg
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+PF04518600-0.3mg+Avelumab-10mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
3
|
3
|
9
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
4
|
3
|
3
|
9
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab + Immunotherapy in Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab+Utomilumab+Avelumab-3mg
n=5 Participants
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+Utomilumab+Avelumab-10mg
n=4 Participants
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
-PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
|
PF04518600-0.3mg
n=3 Participants
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg
n=3 Participants
* Rituximab is administered intravenously per institutional standards
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+PF04518600-0.3mg+Avelumab-10mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants
|
61 years
n=7 Participants
|
58 years
n=5 Participants
|
65 years
n=4 Participants
|
57 years
n=21 Participants
|
—
|
—
|
58 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
ECOG Performance Status
0 - Fully active, able to carry on all pre-disease performance without restriction
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
ECOG Performance Status
1 - Restricted in physically strenuous activity but able to carry out light or sedentary work
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 6 months total, assessed after each 28-day cyclePopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Patients assessed for DLT after each 28-day cycle of treatment. Up to two cohorts of 3 patients per dose level plus expansion cohort. Rituximab/Utomilumab/Avelumab arm assessed 2 dose levels. Rituximab/Utomilumab/PF04518600 assessed 3 dose levels. Rituximab/PF04518600/Avelumab assessed 2 dose levels.
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dosing
Rituximab
|
375 mg
|
—
|
375 mg
|
375 mg
|
NA mg
This cohort did not receive this treatment
|
375 mg
|
—
|
|
Recommended Phase 2 Dosing
PF-04518600
|
0.3 mg
|
—
|
NA mg
This cohort did not receive this treatment
|
NA mg
This cohort did not receive this treatment
|
0.3 mg
|
0.3 mg
|
—
|
|
Recommended Phase 2 Dosing
Utomilumab
|
100 mg
|
—
|
100 mg
|
100 mg
|
NA mg
This cohort did not receive this treatment
|
NA mg
This cohort did not receive this treatment
|
—
|
|
Recommended Phase 2 Dosing
Avelumab
|
NA mg
This cohort did not receive this treatment
|
—
|
3 mg
|
10 mg
|
NA mg
This cohort did not receive this treatment
|
NA mg
This cohort did not receive this treatment
|
—
|
PRIMARY outcome
Timeframe: Response assessed after completing treatment (6 months)Population: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Per 2014 Lugano criteria, a complete response is defined as PET-CT, score 1, 2, or 3\* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response Per Lugano Criteria
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Response assessed after completing treatment (6 months)Population: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Per 2014 Lugano criteria, partial response is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by \>50% in length beyond normal
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Partial Response Per Lugano Criteria
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Response assessed after completing treatment (6 months)Population: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Objective response rate is defined as complete + partial response (CR + PR) Per 2014 Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3\* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease Per 2014 Lugano criteria, PR is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by \>50% in length beyond normal
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Objective Response Per Lugano Criteria
|
3 Participants
|
—
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Response assessed after completing treatment (6 months)Population: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Objective response rate is defined as complete + partial response (CR + PR) Per LYRIC criteria, CR is defined as PET-CT, score 1, 2, or 3\* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease Per LYRIC criteria, PR is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by \>50% in length beyond normal
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Objective Response Per LYRIC Criteria
|
3 Participants
|
—
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Response assessed after completing treatment (6 months)Population: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Per LYRIC criteria, complete response is defined as PET-CT, score 1, 2, or 3\* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response Per LYRIC Criteria
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 monthsPopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Time from registration until earlier of progression (Lugano criteria) or death from any cause, censored at date last known alive and progression-free
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival Per Lugano Criteria
|
6.8 months
Interval 0.0 to 12.5
|
—
|
7.0 months
Interval 0.0 to 12.6
|
6.1 months
Interval 3.0 to 7.5
|
2.7 months
Interval 1.5 to 12.7
|
2.4 months
Interval 0.0 to 3.2
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 monthsPopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Time from registration until earlier of progression (LYRIC criteria) or death from any cause, censored at date last known alive and progression-free
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival Per LYRIC Criteria
|
NA months
Interval 0.0 to 12.5
The median PFS has not yet been reached
|
—
|
7.2 months
Interval 0.0 to 12.6
|
6.1 months
Interval 3.0 to 7.5
|
2.7 months
Interval 1.5 to 12.7
|
2.4 months
Interval 0.0 to 3.2
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 monthsPopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Time from registration until death from any cause, censored at date last known alive
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
NA months
Interval 2.2 to 15.6
The median OS has not yet been reached due to an insufficient number of events. No deaths were observed in this cohort--full ranges include censoring/follow-up times.
|
—
|
28.2 months
Interval 14.1 to 36.3
|
12.9 months
Interval 2.3 to 19.0
|
NA months
Interval 31.8 to 36.7
The median OS has not yet been reached due to an insufficient number of events. No deaths were observed in this cohort--full ranges include censoring/follow-up times.
|
NA months
Interval 0.3 to 16.9
The median OS has not yet been reached due to an insufficient number of events. No deaths were observed in this cohort--full ranges include censoring/follow-up times.
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (approximately 6 months) of treatmentPopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Number of patients who experience any adverse event with grade 3 or higher regardless of attribution to one or more study treatments
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 and Higher Toxicities
|
2 Participants
|
—
|
5 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (approximately 6 months) of treatmentPopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Number of patients who experience any adverse event with grade 3 or higher related to one or more study treatments
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 and Higher Related Toxicities
|
2 Participants
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (approximately 6 months) of treatment followedPopulation: All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg)
Number of patients who experience any adverse event with grade 2 or higher regardless of treatment attribution
Outcome measures
| Measure |
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 Participants
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 1
n=6 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/Avelumab - Level 2
n=4 Participants
Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab/Utomilumab/PF04518600 - Level 1
n=3 Participants
Dose level 0: PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/Utomilumab/PF04518600 - Level 2
n=3 Participants
Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab/PF04518600/Avelumab - Level 2
Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
* Avelumab is administered intravenously over 1 hour once every 2 weeks
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 2 or Higher Toxicity
|
8 Participants
|
—
|
6 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
Adverse Events
Rituximab+Utomilumab+Avelumab-3mg
Rituximab+Utomilumab+Avelumab-10mg
PF04518600-0.3mg
Rituximab+PF04518600-0.3mg
Rituximab+Utomilumab+PF04518600-0.3mg
Rituximab+PF04518600-0.3mg+Avelumab-3mg
Rituximab+PF04518600-0.3mg+Avelumab-10mg
Serious adverse events
| Measure |
Rituximab+Utomilumab+Avelumab-3mg
n=6 participants at risk
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+Utomilumab+Avelumab-10mg
n=4 participants at risk
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
-PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
|
PF04518600-0.3mg
n=3 participants at risk
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg
n=3 participants at risk
* Rituximab is administered intravenously per institutional standards
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 participants at risk
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+PF04518600-0.3mg+Avelumab-10mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Obstruction gastric
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Nervous system disorders
Intracranial hemorrhage
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
Other adverse events
| Measure |
Rituximab+Utomilumab+Avelumab-3mg
n=6 participants at risk
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+Utomilumab+Avelumab-10mg
n=4 participants at risk
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
-PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
|
PF04518600-0.3mg
n=3 participants at risk
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg
n=3 participants at risk
* Rituximab is administered intravenously per institutional standards
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+Utomilumab+PF04518600-0.3mg
n=9 participants at risk
* Rituximab is administered intravenously per institutional standards
* Utomilumab is administered intravenously over 1 hour once every
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
|
Rituximab+PF04518600-0.3mg+Avelumab-3mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 3mg/kg
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
Rituximab+PF04518600-0.3mg+Avelumab-10mg
* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
* Avelumab is administered intravenously over 1 hour once every 2 weeks, 10mg/kg
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
|
|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
50.0%
2/4 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
66.7%
2/3 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
50.0%
2/4 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
22.2%
2/9 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 5 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 2 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Gastrointestinal disorders
Esophageal stenosis
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
16.7%
1/6 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
25.0%
1/4 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
33.3%
1/3 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/9 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
|
Eye disorders
Watering eyes
|
0.00%
0/6 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/4 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
0.00%
0/3 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
11.1%
1/9 • Number of events 1 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
—
0/0 • Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place