Nivolumab + Docetaxel + ADT for Metastatic Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining hormonal therapy, chemotherapy, and immunotherapy can effectively treat metastatic hormone-sensitive prostate cancer. The treatment includes Androgen Deprivation Therapy (which reduces male hormones), Docetaxel (a chemotherapy drug), and Nivolumab (an immunotherapy drug). The study examines different groups based on specific tumor characteristics. Men diagnosed with prostate cancer that has spread to other parts of the body and have not yet received certain treatments might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that certain medications, like second-generation hormonal agents, are not allowed, and antiandrogens must be discontinued before registration. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using nivolumab and docetaxel together may help treat advanced prostate cancer. In earlier studies, researchers tested this combination in patients who hadn't received chemotherapy before. The safety of these drugs together is similar to when each is used alone. However, some serious side effects were reported, including three treatment-related deaths in one study. One death resulted from lung inflammation due to nivolumab, and two were due to lung infections from docetaxel.
Androgen deprivation therapy (ADT) is a common treatment for prostate cancer. It is well-known and generally well-tolerated. Drugs like leuprolide, goserelin acetate, and degarelix are often used for ADT and have a proven safety record.
Overall, the treatments in this trial have been used before, both alone and together, with known safety profiles. However, like any treatment, potential risks and side effects must be considered.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this combination treatment for metastatic prostate cancer because it leverages the power of immunotherapy alongside traditional chemotherapy and hormone therapy. Nivolumab, an immune checkpoint inhibitor, helps the immune system better recognize and attack cancer cells, offering a novel mechanism of action compared to standard treatments like solely using androgen deprivation therapy (ADT) and docetaxel. By combining Nivolumab with ADT and Docetaxel, this approach aims to enhance the overall anti-cancer response, potentially improving outcomes for patients, especially those with specific tumor characteristics like DNA damage repair defects or inflamed tumors. This synergy could represent a significant advancement over existing therapies, which typically focus on one treatment modality at a time.
What evidence suggests that this trial's treatments could be effective for metastatic prostate cancer?
Research has shown that combining docetaxel with androgen deprivation therapy (ADT) extends the lives of men with metastatic hormone-sensitive prostate cancer compared to ADT alone. Docetaxel is both effective and safe for treating this type of cancer. In this trial, participants will receive a combination of docetaxel, ADT, and nivolumab. While docetaxel has demonstrated consistent success, the evidence for nivolumab, an immunotherapy drug, remains less clear. Some early studies suggest it might help when combined with other treatments for prostate cancer, but it is not yet approved for this condition and lacks strong evidence of effectiveness on its own. Overall, these treatments aim to combat cancer through different mechanisms.678910
Who Is on the Research Team?
Xiao Wei
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Men over 18 with newly diagnosed high-volume metastatic hormone-sensitive prostate cancer, not previously treated with ADT, chemotherapy or immunotherapy. They must have a good performance status and adequate organ function. Men must agree to use contraception during the study and for 7 months after.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive androgen deprivation therapy, docetaxel, and nivolumab. Nivolumab is given once every 3 weeks for cycle 1-6 and then every 4 weeks during subsequent cycles. Docetaxel is given once every 3 weeks for cycle 1-6.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including time to clinical progression and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- Androgen Deprivation Therapy
- Docetaxel
- Nivolumab
Androgen Deprivation Therapy is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xiao X. Wei, MD
Lead Sponsor
Xiao X. Wei
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