PROSTATE: 1st Line Chemo: Nivo+Taxotere: 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

Title
Bristol-Myers Squibb CA209-7DX (Prostate)
Study Title

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

Site Link
Malignancy
Prostate Cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line Chemo
Investigational Agent
Nivolumab
Drug Class
PD-1 inhibitor
PI
Dan Vaena, MD
Sponsor
Bristol-Myers Squibb
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Adenocarcinoma of the prostate with evidence of stage IV disease
  • ECOG PS 0-1
  • Documented progression per PCWG3 criteria within 6 months prior to screening
  • Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or bilateral orchiectomy
  • Chemotherapy naive and received 1 or 2 prior second generation hormonal therapies
  • No active brain mets
  • No prior malignancy within previous 3 years except for local malignancies that have been cured
  • No known or suspected autoimmune disease
  • No need for steroids
  • No prior treatment with docetaxel or other chemotherapy for CRPC
Objective
  • Primary
    • Radiographic PFS per PCWG3
    • OS
  • Secondary
    • ORR
    • DOR
    • PSA response rate
    • Time to response
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X