Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer
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ClinicalTrials.gov Identifier: NCT03637543 |
Recruitment Status :
Active, not recruiting
First Posted : August 20, 2018
Last Update Posted : January 23, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 16, 2018 | ||||
First Posted Date ICMJE | August 20, 2018 | ||||
Last Update Posted Date | January 23, 2024 | ||||
Actual Study Start Date ICMJE | October 18, 2018 | ||||
Actual Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Disease Control [ Time Frame: 12 weeks ] Proportion of patients with high-risk biochemically-recurrent (BCR) prostate cancer (PCa) that experiences decline or stabilization in PSA (without symptomatic/radiographic progression) after 12 weeks of nivolumab treatment
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer | ||||
Official Title ICMJE | A Phase 2 Study of Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer | ||||
Brief Summary | This research study is studying an immune-based cancer drug as a possible treatment for prostate cancer. The drug involved in this study is: -Nivolumab |
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved nivolumab for this specific disease but it has been approved for other uses. Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer. In this research study, the investigators are investigating whether nivolumab has any activity in patients who have a rising PSA (prostate specific antigen) after previously undergoing surgery or radiation for prostate cancer. Although nivolumab was previously not found to have significant effect in advanced prostate cancer after all other therapies had failed, based on new research, the investigators are testing whether nivolumab could have a greater effect earlier in the disease course and before patients receive hormone therapies. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Drug: Nivolumab
Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
Other Name: Opdivo
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
31 | ||||
Original Estimated Enrollment ICMJE |
34 | ||||
Estimated Study Completion Date ICMJE | March 31, 2025 | ||||
Actual Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
With linear regression model of normal logarithm of PSA and time, based on:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03637543 | ||||
Other Study ID Numbers ICMJE | 18-249 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | David J. Einstein, Beth Israel Deaconess Medical Center | ||||
Original Responsible Party | David J. Einstein, MD, Dana-Farber Cancer Institute, Principal Investigator | ||||
Current Study Sponsor ICMJE | Beth Israel Deaconess Medical Center | ||||
Original Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Beth Israel Deaconess Medical Center | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |