Nivolumab for Recurrent Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests nivolumab, a non-hormonal treatment, for men whose prostate cancer has returned after initial treatment. The goal is to determine if nivolumab can effectively manage prostate cancer in those with specific genetic changes, such as high tumor mutational burden or certain protein losses, which suggest a positive response to this drug. Men who have previously undergone surgery or radiation for prostate cancer and now have rising PSA levels, indicating recurrent cancer, might be suitable candidates, especially if they show no signs of cancer spread and possess specific genetic markers. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications, such as oral anti-androgens and androgen synthesis inhibitors, at least two weeks before starting. If you're on 5-alpha reductase inhibitors, you must have been stable on them for the past six months. Other medications, especially those with potential liver toxicity, should be used with caution.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that nivolumab has been tested in various studies to assess its safety and tolerability. In patients with recurrent prostate cancer, nivolumab is generally well-tolerated, meaning most can take the treatment without major issues.
Some studies have found that side effects, known as "adverse events," can occur. Common ones include fatigue, rash, or itching. More serious side effects are less common but can happen. Nivolumab is already approved for treating other types of cancer, which provides some confidence in its safety for prostate cancer trials.
This trial is in Phase 2, indicating that earlier results showed nivolumab was safe enough to continue studying. This phase gathers more detailed information on safety and efficacy.
Overall, nivolumab appears to be a promising option, with many patients tolerating it well. However, like any treatment, there are risks of side effects that should be considered.12345Why do researchers think this study treatment might be promising for prostate cancer?
Nivolumab is unique because it is an immunotherapy drug, specifically a checkpoint inhibitor, that works by enhancing the body's immune response to recognize and attack cancer cells. Most treatments for recurrent prostate cancer, like hormone therapy or chemotherapy, focus on reducing or blocking hormones that fuel cancer growth or directly killing cancer cells. But Nivolumab targets the PD-1 pathway, a mechanism cancers often use to hide from the immune system. Researchers are excited about this treatment because it offers a new way to potentially control or eliminate cancer by empowering the immune system, which could lead to longer-lasting responses with possibly fewer side effects.
What evidence suggests that nivolumab might be an effective treatment for recurrent prostate cancer?
Research has shown that nivolumab, a drug that helps the immune system fight cancer, holds promise for treating prostate cancer that has returned after initial treatment. In this trial, participants with biochemically recurrent prostate cancer will receive nivolumab. Studies found that when combined with radiotherapy, 90.3% of patients did not show signs of cancer returning, compared to the usual 75%. This is particularly important for patients with certain biomarkers, such as MMR deficiency, which can make tumors more responsive to treatments like nivolumab. Early results suggest that nivolumab could serve as an effective alternative to traditional hormone treatments, especially for those with specific genetic markers. Overall, the evidence supports nivolumab's potential to improve outcomes for prostate cancer patients whose cancer has returned.16789
Who Is on the Research Team?
Mark Markowski, MD/PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for men over 18 with biochemically recurrent prostate cancer that's MMR-deficient, indicated by specific genetic markers. They must have a PSA level >=1.0 ng/mL and normal organ/bone marrow function. Prior local therapy is required but no recent metastatic disease or ADT treatment in the past 6 months. Participants need a life expectancy of at least 6 months and agree to contraception use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab as a non-hormonal therapy for biochemically recurrent prostate cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
Trial Overview
The trial tests Nivolumab, an immune checkpoint inhibitor, as a non-hormonal treatment option for prostate cancer patients with certain biomarkers (dMMR, MSI-H, high TMB). It offers an alternative to standard care like surveillance or hormone therapy which lacks survival benefits in this stage.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with previous prostatectomy or radiation therapy who subsequently developed detectable prostate specific antigen (PSA) levels ("biochemically recurrent prostate cancer").
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
NCT04019964 | Nivolumab in Biochemically Recurrent ...
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) ...
2.
cancernetwork.com
cancernetwork.com/view/nivolumab-rt-improves-biochemical-recurrence-outcomes-in-prostate-cancerNivolumab/RT Improves Biochemical Recurrence ...
At 2 years, the FFBR rate was 90.3% among patients who received nivolumab plus radiotherapy compared with a historical control rate of 75% (P = ...
Best Approaches and Updates for Prostate Cancer ...
Treatment with SRT was associated with a threefold reduction in prostate cancer–specific mortality compared with observation (HR, 0.32; p < .001). The outcome ...
Moffitt Study Shows Promising Results for Treating ...
The key outcome of the study was the improvement in biochemical recurrence-free survival. Biochemical recurrence refers to an increase in ...
Combination of Nivolumab Immunotherapy with Radiation ...
Nivolumab plus SOC for GG5 PCa demonstrated an improvement in 2-year FFBR to historic rate and was well tolerated.
Study Details | NCT03637543 | Nivolumab in Patients With ...
Although nivolumab was previously not found to have significant effect in advanced prostate cancer after all other therapies had failed, based on new research, ...
A phase II study of nivolumab in patients with high-risk ...
A phase II study of nivolumab in patients with high-risk biochemically recurrent (BCR) prostate cancer (PCa). Authors: David Johnson ...
The Potential Role for Immunotherapy in Biochemically ...
RATIONALE FOR IMMUNOTHERAPY IN BIOCHEMICALLY RECURRENT PROSTATE CANCER. There are several potentially important biologic characteristics that differentiate the ...
Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in ...
Conclusions: In this population, combining nivolumab with pTVG-HP vaccination was safe, and immunologically active, prolonged the time to ...
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