Trial Outcomes & Findings for Nivolumab in Biochemically Recurrent dMMR Prostate Cancer (NCT NCT04019964)
NCT ID: NCT04019964
Last Updated: 2026-05-15
Results Overview
Percentage of participants who have received at least 1 dose of Nivolumab who experience a confirmed \>=50% decline in prostate specific antigen (PSA) from baseline, as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
up to 6 months post-intervention, up to 2 years of treatment
Results posted on
2026-05-15
Participant Flow
Participant milestones
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab in Biochemically Recurrent dMMR Prostate Cancer
Baseline characteristics by cohort
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Age, Continuous
|
70 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Prostate-Specific Antigen (PSA)
|
3.2 ng/ml
n=11 Participants
|
|
Prostate-Specific Antigen Doubling Time (PSADT)
|
5.9 months
n=11 Participants
|
|
Testosterone
|
505 ng/dl
n=11 Participants
|
|
Gleason score
Gleason score 7
|
4 Participants
n=11 Participants
|
|
Gleason score
Gleason score 8
|
1 Participants
n=11 Participants
|
|
Gleason score
Gleason score 9
|
3 Participants
n=11 Participants
|
|
Gleason score
Gleason score 10
|
0 Participants
n=11 Participants
|
|
Prostate Directed Therapy
Surgery
|
7 Participants
n=11 Participants
|
|
Prostate Directed Therapy
Radiation
|
1 Participants
n=11 Participants
|
|
Genomic Abnormality
MSH2 mutation
|
3 Participants
n=11 Participants
|
|
Genomic Abnormality
PMS2 mutation
|
2 Participants
n=11 Participants
|
|
Genomic Abnormality
MSH6 mutation
|
1 Participants
n=11 Participants
|
|
Genomic Abnormality
MLH1 mutation
|
1 Participants
n=11 Participants
|
|
Genomic Abnormality
CDK12 mutation
|
1 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: up to 6 months post-intervention, up to 2 years of treatmentPercentage of participants who have received at least 1 dose of Nivolumab who experience a confirmed \>=50% decline in prostate specific antigen (PSA) from baseline, as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.
Outcome measures
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Percentage of Participants With PSA50 Response
|
2 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until the date of first documented PSA increase of 25%, assessed up to 28 days after last treatment dose.Median time from initiation of therapy until confirmed PSA increase of 25% (PCWG3). Estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
PSA Progression-free Survival (PSA-PFS)
|
6.7 months
Interval 3.9 to
Upper bound of the confidence interval not reached
|
SECONDARY outcome
Timeframe: up to 6 months post-intervention, up to 2 years of treatmentNumber of participants who achieve PSA \< 0.1 ng/mL lasting at least 12 weeks.
Outcome measures
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Number of Participants Who Achieve Undetectable PSA
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 100 days post-intervention, up to 2 years of treatmentNumber of participants experiencing adverse events Grade 3 or higher as defined by CTCAE v5.0
Outcome measures
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Safety and Tolerability of Nivolumab in Biochemically Recurrent Prostate Cancer as Assessed by Number of Participants Experiencing Treatment-Emergent Adverse Events
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 6 months post-intervention, up to 2 years of treatmentMedian time from first dose of nivolumab until the development of radiographic metastatic disease on CT imaging and/or bone scan, as defined by PCWG3
Outcome measures
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Metastasis-free Survival
|
NA months
Standard Deviation NA
Insufficient number of events
|
SECONDARY outcome
Timeframe: up to 6 months post-intervention, up to 2 years of treatmentMedian time from first dose of nivolumab until next systemic therapy
Outcome measures
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 Participants
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Time to Initiation of Next Systemic Therapy
|
NA months
Standard Deviation NA
Insufficient number of events
|
Adverse Events
Nivolumab in Biochemically Recurrent Prostate Cancer
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 participants at risk
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
Infections and infestations
COVID-19 Hospitalization
|
12.5%
1/8 • Number of events 1 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
Other adverse events
| Measure |
Nivolumab in Biochemically Recurrent Prostate Cancer
n=8 participants at risk
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab: Nivolumab 480mg intravenously every 4 weeks
|
|---|---|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 8 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash/Pruritis
|
50.0%
4/8 • Number of events 7 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
|
Metabolism and nutrition disorders
Weight loss/anorexia
|
37.5%
3/8 • Number of events 4 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
|
Nervous system disorders
Dizziness
|
37.5%
3/8 • Number of events 4 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
2/8 • Number of events 2 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
|
General disorders
Lower external edema
|
25.0%
2/8 • Number of events 2 • From time of consent up to 100 days after last treatment dose, up to 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place