Nivolumab in Men with Metastatic Castration-resistant Prostate Cancer

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer (CheckMate 7DX: CHECKpoint pathway and nivoluMAB clinical Trial Evaluation 7DX)

• IRAS ID

  272127

• Contact name

  Peter Hoskin

• Contact email

  peterhoskin@nhs.net

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2019-002030-36

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT04100018

• Duration of Study in the UK

  5 years, 2 months, 29 days

• Research summary

  Prostate cancer is a leading cause of cancer mortality in men worldwide. The sponsor Bristol-Myers Squibb has begun a study of an investigational medicine called nivolumab, in combination with standard of care docetaxel chemotherapy, as a possible treatment for metastatic castration-resistant prostate cancer (mCRPC).

  Researchers are studying the clinical benefit, long-term safety, and survival data of the investigational treatment (nivolumab + docetaxel + prednisone) followed by nivolumab alone in participants with mCRPC. Nivolumab is a type of immunotherapy that works by encouraging the body’s own immune system to attack the cancer cells.

  The main purpose of this study is to learn how well the investigational treatment works and how safe it is compared with other therapies that have already been approved by regulatory authorities (standard-of-care treatments), in this case, docetaxel + prednisone.

  This study will include about 984 people with prostate cancer in approximately 252 centres worldwide.

  Participants will be randomly assigned to receive 1 of the following treatments:
  • Study medicine combined with standard-of-care chemotherapy (nivolumab combined with docetaxel + prednisone), followed by treatment with nivolumab alone; or,
  • Placebo combined with standard-of-care chemotherapy (placebo combined with docetaxel + prednisone), followed by treatment with placebo alone

  Participants will receive study treatment until their disease progresses or the side effects are not acceptable. The study doctor may decide that the participant may continue to receive treatment after their disease progresses. Participants will receive study treatment for a maximum of 2 years.

  Participants will have Follow-Up Visits approximately 30 days and 100 days after their last dose of study medicine, study staff will follow up every 3 months until participants leave the study or the study ends.

  This study involves procedures including: Physical exams, vital signs, ECG, blood, tissue and urine samples, optional stool samples, bone scans (CT or MRI) and questionnaires.

  Lay summary of study results: CA209-7DX did not meet the primary objective/endpoints. The addition of nivolumab to docetaxel did not demonstrate a statistical improvement in radiographic Progression Free Survival (rPFS) per Blind Investigator Committee Review (BICR) or Overall Survival(OS) with nivo+doce vs placebo+doce for patients with metastatic castration resistant prostate cancer (mCRPC) post novel antiandrogen therapies (NAT).
  The safety profile of nivolumab+docetaxel and placebo+docetaxel were consistent with the known safety profile of these treatments. No new safety concerns were identified.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  19/LO/1754

• Date of REC Opinion

  26 Nov 2019

• REC opinion

  Further Information Favourable Opinion