A Study of Nivolumab or Placebo in Combination with Docetaxel in Men with Advanced Castration-Resistant Prostate Cancer (CheckMate 7DX)
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-Resistant Prostate Cancer (NCT04100018)
The purpose of this study is to test the safety and efficacy of nivolumab with docetaxel in men with advanced castration resistant prostate cancer (mCRPC), who have progressed after second-generation hormonal manipulation. Patients eligible to participate in this study will receive Nivolumab, docetaxel, and prednisone or docetaxel, prednisone, and placebo.
Nivolumab is approved to treat other types of cancer, but is not currently approved to treat metastatic prostate cancer. Immune-oncology medicines are types of immunotherapies that specifically fight cancers.
Docetaxel is a chemotherapy medicine, which has been approved by the FDA to treat prostate, lung, and breast cancers.
What is the purpose?
The purpose of this study is to test if nivolumab with docetaxel is safe and can slow down or stop the growth of mCRPC in men with advanced castration resistant prostate cancer, who have progressed after second-generation hormonal manipulation.
Who can participate?
Participation in this clinical trial is determined using eligibility criteria. Some key eligibility criteria are provided below.
You may be able to participate if:
- You have had a surgical/medical castration procedure.
- You have had ongoing androgen deprivation therapy or had surgical/medical castration, but your cancer has gotten worse or has not responded to the treatment you have been given.
You may be excluded from this trial if:
- You have an infection or autoimmune disease.
- You have been diagnosed with cancer that has spread to your brain.
This is a phase 3 clinical trial that will enroll 984 participants. The trial started December 6, 2019 and the primary completion date is in March 19, 2024.
Possible patient benefits
- Patients will be under close medical supervision for safety during the study period.
Possible patient risks:
- The use of nivolumab may also cause side-effects.
Organization: Bristol-Myers Squibb (BMS)
If you are interested in this trial, review the following:
PHEN Contact: 617-481-4020
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.