Trial Outcomes & Findings for Avelumab Plus 2nd-generation ADT in African American Subjects With mCRPC (NCT NCT03770455)
NCT ID: NCT03770455
Last Updated: 2024-07-09
Results Overview
The primary endpoint is a PSA response at 8 weeks or greater from starting study treatment and with a minimum of 3 treatments administered. A PSA response is defined as a ≥50% PSA decline at 8 weeks or greater from the time of starting study treatment. The two-stage minimax design of the study will be utilized to determine whether further investigation of the study drug is warranted.
TERMINATED
PHASE2
8 participants
8 Weeks, 6 months
2024-07-09
Participant Flow
Recruitment Period: January 25, 2019 - 11 September 2020 Location: Tulane Cancer Center
Participant milestones
| Measure |
Avelumab + 2nd Generation ADT
Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Avelumab + 2nd Generation ADT
Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)
|
|---|---|
|
Overall Study
Screen failures
|
3
|
Baseline Characteristics
Avelumab Plus 2nd-generation ADT in African American Subjects With mCRPC
Baseline characteristics by cohort
| Measure |
Avelumab + 2nd Generation ADT
n=5 Participants
Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 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
|
PRIMARY outcome
Timeframe: 8 Weeks, 6 monthsPopulation: Study closed early due to safety concerns. None of the participants reached the 8 weeks time point pre-specified for this analysis and hence PSA response data were not collected.
The primary endpoint is a PSA response at 8 weeks or greater from starting study treatment and with a minimum of 3 treatments administered. A PSA response is defined as a ≥50% PSA decline at 8 weeks or greater from the time of starting study treatment. The two-stage minimax design of the study will be utilized to determine whether further investigation of the study drug is warranted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pPFS will be assessed 12 months after enrollment of last subject.Population: Study closed early due to safety concerns. Statistically underpowered and did not meet timeframe of pPFS assessed at 12 months after enrollment of last subject, so the investigators were not able to calculate PSA Progression-free Survival due to early closure, and none of the 5 participants had data to be summarized.
PSA progression-free survival (pPFS) defined as the time from enrollment until PSA progression by Prostate Cancer Working Group 3 (PCWG3) or death, whichever occurs earlier. Subjects without pPFS at the time of data cut-off will be censored at the date of last adequate cancer assessment. PSA progression-free survival will be reported using Kaplan-Meier estimates, with 95% confidence interval for median time-to-event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: rPFS will be assessed 12 months after enrollment of last subject.Population: Study closed early due to safety concerns. Statistically underpowered and did not meet timeframe of rPFS assessed at 12 months after enrollment of last subject, so the investigators were not able to calculate Radiographic Progression-free Survival due to early closure, and none of the 5 participants had data to be summarized.
Radiographic progression-free survival (rPFS) defined as the time from enrollment until radiographic progression by PCWG3 or death, whichever occurs earlier. Subjects without rPFS at the time of data cut-off will be censored at the date of last known to be alive. Radiographic progression-free survival will be reported using Kaplan-Meier estimates, with 95% confidence interval for median time-to-event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Overall survival with be assessed at 3 years from time of enrollment of last study subject.Population: Study closed early due to safety concerns. Statistically underpowered and did not meet timeframe of overall survival assessed at 3 years from time of enrollment of last study subject, so the investigators were not able to calculate Overall Survival due to early closure, and none of the 5 participants had data to be summarized.
Overall survival (OS) defined as the time from enrollment until death on study. Subjects who are alive at the time of data cut-off will be censored at the date of last known to be alive. OS will be reported using Kaplan-Meier estimates, with 95% CI for median time-to-event.
Outcome measures
Outcome data not reported
Adverse Events
Avelumab + 2nd Generation ADT
Serious adverse events
| Measure |
Avelumab + 2nd Generation ADT
n=5 participants at risk
Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Gastrointestinal disorders
Colonic perforation
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Musculoskeletal and connective tissue disorders
L2 compression fracture
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Musculoskeletal and connective tissue disorders
Severe pain from back to leg/sciatica
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
Other adverse events
| Measure |
Avelumab + 2nd Generation ADT
n=5 participants at risk
Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
Avelumab: Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
2nd generation ADT (abiraterone or enzalutamide): 2nd generation ADT (abiraterone or enzalutamide)
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 6 • 1 year, 8 months
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • 1 year, 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
60.0%
3/5 • Number of events 10 • 1 year, 8 months
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
20.0%
1/5 • Number of events 2 • 1 year, 8 months
|
|
Endocrine disorders
Hyperthyroidism
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Skin and subcutaneous tissue disorders
Dry skin on feet
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Gastrointestinal disorders
Intermittent diarrhea
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Skin and subcutaneous tissue disorders
Localized rash bilateral elbows
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Gastrointestinal disorders
Ileus
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Hypokaelmia
|
20.0%
1/5 • Number of events 1 • 1 year, 8 months
|
Additional Information
Jodi L. Layton, MD
Tulane University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place