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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

6 months total, assessed after each 28-day cycle

Results posted on

2025-02-06

Participant Flow

The study was terminated early due to the drug manufacturer stopping drug supply.

Participant milestones

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

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 cycle

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)

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

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

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

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

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

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

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 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)

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

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 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)

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

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 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)

Time from registration until death from any cause, censored at date last known alive

Outcome measures

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 treatment

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)

Number of patients who experience any adverse event with grade 3 or higher regardless of attribution to one or more study treatments

Outcome measures

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 treatment

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)

Number of patients who experience any adverse event with grade 3 or higher related to one or more study treatments

Outcome measures

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 followed

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)

Number of patients who experience any adverse event with grade 2 or higher regardless of treatment attribution

Outcome measures

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

Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths

Rituximab+Utomilumab+Avelumab-10mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths

PF04518600-0.3mg

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Rituximab+PF04518600-0.3mg

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Rituximab+Utomilumab+PF04518600-0.3mg

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Rituximab+PF04518600-0.3mg+Avelumab-3mg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Rituximab+PF04518600-0.3mg+Avelumab-10mg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

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

Caron Jacobson, MD

Dana-Farber Cancer Institute

Phone: 617-632-6404

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place