Nivolumab in Biochemically Recurrent dMMR Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04019964|
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : January 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrent Prostate Cancer||Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nivolumab as a Non-Castrating Therapy for MMR-deficient and CDK12- Altered Prostate Cancer With PSA Recurrence After Local Therapy|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
Experimental: 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 480mg intravenously every 4 weeks
Other Name: Opdivo
- Percentage of participants with PSA50 response [ Time Frame: up to 6 months post-intervention ]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.
- PSA progression-free survival (PSA-PFS) [ Time Frame: up to 6 months post-intervention ]Median time from initiation of therapy until confirmed PSA increase of 25% (PCWG3). Estimated using Kaplan-Meier method.
- Number of participants who achieve undetectable PSA [ Time Frame: up to 6 months post-intervention ]Number of participants who achieve PSA < 0.1 ng/mL lasting at least 12 weeks.
- Metastasis-free survival [ Time Frame: up to 6 months post-intervention ]Median time from first dose of nivolumab until the development of radiographic metastatic disease on CT imaging and/or bone scan, as defined by PCWG3
- Time to initiation of next systemic therapy [ Time Frame: up to 6 months post-intervention ]Median time from first dose of nivolumab until next systemic therapy
- Safety and tolerability of Nivolumab in biochemically recurrent prostate cancer as assessed by Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 100 days post-intervention ]Number of participants experiencing adverse events Grade 3 or higher as defined by CTCAE v5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019964
|Contact: Rana Sullivan, RNemail@example.com|
|Contact: Aliya Lalji, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Rana Sullivan, RN 410-614-6337 email@example.com|
|Principal Investigator: Mark Markowski, MD/PhD|
|Principal Investigator:||Mark Markowski, MD/PhD||Johns Hopkins University|