Nivolumab in Biochemically Recurrent dMMR Prostate Cancer (NCT04019964) | Clinical Trial Compass
CompletedPhase 2
Nivolumab in Biochemically Recurrent dMMR Prostate Cancer
United States8 participantsStarted 2020-01-13
Plain-language summary
MMR-deficient cancers of any histologic type appear to be very sensitive to PD-1 blockade with pembrolizumab, and similar data are also beginning to emerge for nivolumab and other immune checkpoint inhibitors. Among the MMR-deficient cancers, the best antitumor responses are often associated with high microsatellite instability (MSI-H status), higher tumor mutational burden (TMB), and higher predicted neoantigen load. Prevalence estimates of MMR deficiency across solid tumor types range from 1% to 20% depending on the type of malignancy. In prostate cancer, 1-3% of unselected cases harbor MMR deficiency and/or microsatellite instability.
For men who previously received definitive treatment for prostate cancer and subsequently develop detectable prostate specific antigen (PSA) levels, the clinical state is known as biochemically recurrent prostate cancer. The current standard of care treatment for patients with biochemically recurrent prostate cancer is either surveillance or androgen deprivation therapy (ADT). ADT has not been shown to provide a survival benefit in this setting, and the decision to initiate ADT will depend on patient preference and perceived risks of the disease. A non-hormonal therapy such as nivolumab would provide an alternative to ADT in patients with biomarker selected (i.e. dMMR, MSI-H, high TMB, or CDK12-altered) biochemically recurrent prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide signed informed consent and HIPAA authorization for the release of personal health information
* Males aged 18 years and above
* Prior local therapy with prostatectomy or EBRT/brachytherapy is required
* Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months.
* Absolute PSA \>=1.0 ng/mL at screening
* Must have at least one of the following genetic alterations identified using archival tissue (i.e. prostate needle biopsy prior to radiation therapy or prostatectomy specimen):
* Microsatellite instability (MSI-high) status by clinical grade testing
* MMR protein loss (MSH2, MSH6, MLH1, PMS2) by immunohistochemistry
* Inactivating mutation of MSH2, MSH6, MLH1 or PSM2 by clinical grade genomic testing
* Tumor mutational burden \>= 20 mutations/megabase (TMB \>=20 muts/Mb) by clinical grade testing
* Inactivating mutation (at least monoallelic of CDK12 by clinical grade testing
* Serum testosterone \>= 150 ng/dL
* No radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks.
* Karnofsky Performance Status (KPS) \>= 70% within 14 days before start of study treatment (ECOG \<=1)
* Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
* Hemoglobin \>= 9.0 g/dL with no blood transfusion in the past 28 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With PSA50 Response
Timeframe: up to 6 months post-intervention, up to 2 years of treatment
Trial details
NCT IDNCT04019964
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins