CTIS2022-502909-15-00
Active, not recruiting
Phase 1
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer - CA209650
Not provided0 sites477 target enrollmentJune 28, 2023
ConditionsMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Sponsor
- Not provided
- Enrollment
- 477
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ECOG performance status 0\-1, Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI), Ongoing androgen deprivation therapy (ADT) with a Gonadotropinreleasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of \=1\.73nmol/L (50ng/dL), For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: \- Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
Exclusion Criteria
- •Presence of visceral metastases in the liver, Active brain metastases or leptomeningeal metastases, Active, known, or suspected autoimmune disease or infection, Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, or anti\- CTLA\-4 antibody, or any other antibody or drug specifically targeting Tcell co\-stimulation or checkpoint pathways., For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: \- Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab., For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: \- Have received systemic anti\-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).
Outcomes
Primary Outcomes
Not specified
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