Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men, with Metastatic Castration-Resistant Prostate Cancer

Phase 1

• Conditions: Metastatic Castration-Resistant Prostate Cancer; MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001928-54-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 497

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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 199
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 298

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified