A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: Nivolumab; Biological: Ipilimumab; Drug: Cabazitaxel; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02985957

2016-001928-54 (EudraCT Number)

CA209-650

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).

Enrollment: 351 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (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 Gonadotropin-releasing 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 T-cell 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
• Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 7 patient groups

Cohort A (Arm A)

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Cohort B (Arm B)

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Cohort C (Arm C)

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Cohort D (Arm D1)

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Cohort D (Arm D2)

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Cohort D (Arm D3)

Experimental group

Treatment:

Biological: Ipilimumab

Cohort D (Arm D4)

Experimental group

Treatment:

Drug: Prednisone

Drug: Cabazitaxel