Trial Outcomes & Findings for Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors (NCT NCT02988843)
NCT ID: NCT02988843
Last Updated: 2020-12-10
Results Overview
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
1 year
Results posted on
2020-12-10
Participant Flow
Participant milestones
| Measure |
Brentuximab Vedotin & Bevacizumab
* Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.
* Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.
Brentuximab Vedotin: Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)
Bevacizumab: 15 mg/kg every 21 days
|
|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin & Bevacizumab
n=1 Participants
Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearChanges in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.
Outcome measures
| Measure |
Brentuximab Vedotin & Bevacizumab
n=1 Participants
Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
|
|---|---|
|
Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.
Complete Remission
|
0 Participants
|
|
Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.
Progressive disease
|
0 Participants
|
|
Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.
Baseline
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsIncidence of Progression-free survival - Number of patients who were alive and did not have disease progression
Outcome measures
| Measure |
Brentuximab Vedotin & Bevacizumab
n=1 Participants
Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
|
|---|---|
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Number of Participants Experiencing Progression Free Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants who were alive at 2 years (Overall survival)
Outcome measures
| Measure |
Brentuximab Vedotin & Bevacizumab
n=1 Participants
Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
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|---|---|
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Number of Participants Who Were Alive at 2 Years - Overall Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 YearsSafety/ toxicity of brentuximab vedotin, measured by incidence of AEs/SAEs
Outcome measures
| Measure |
Brentuximab Vedotin & Bevacizumab
n=1 Participants
Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
|
|---|---|
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Number of Participants Experiencing Adverse Events (AE) and Severe Adverse Events (SAE)
|
1 Participants
|
Adverse Events
Brentuximab Vedotin & Bevacizumab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brentuximab Vedotin & Bevacizumab
n=1 participants at risk
Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days
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|---|---|
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General disorders
Chills
|
100.0%
1/1 • Number of events 2 • 2 years
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Enterocolitis
|
100.0%
1/1 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 2 • 2 years
|
Additional Information
Dr. Shilpa Gupta
Masonic Cancer Center, University of Minnesota
Phone: 612 624 0123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place