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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
  • Histologic confirmation of adenocarcinoma of the prostate without small cell features
  • Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue lesions on CT/MRI
  • ECOG PS 0-1
  • Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or bilateral orchiectomy
  • Documented disease progression per PCWG3 criteria within 6 months prior to screening
  • Only one prior 2nd generation hormonal therapy in the metastatic setting
    • Patients may have received two prior 2nd gen HT (abi + enza or apalutamide or darolutamide) if and only if the first drug had been used in the non-metastatic setting
  • Chemotherapy naive for metastatic CRPC
  • Must have progressed during or after 2nd gen hormonal therapy or have documented intolerance to 2nd gen HT
  • No active brain mets
  • No known or suspected autoimmune disease
  • No condition requiring systemic corticosteroids (>10 mg prednisone or equivalent)
  • No prior treatment with PD-1 or PD-L1 antibodies
  •  
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