A Study to Evaluate Preliminary Efficacy of Nivolumab Plus Ipilimumab, Ipilimumab Alone, 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); MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001928-54-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 495

Inclusion Criteria

- Men, 18 years or older with histologic confirmation of adenocarcinoma of the prostate and evidence of
Stage IV disease (defined by AJCC)
-ECOG performance status 0-1
-Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL)
-Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ?28 days before enrollment
-Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before
-Sufficient fresh or archival tumor tissue obtained within 5 years prior to enrollment from a metastatic tumor lesion or from a primary tumor lesion that has not been previously irradiated (formalin-fixed paraffin-embedded [FFPE] block or unstained tumor tissue sections).
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 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 297

Exclusion Criteria

-Cancer that has spread to the liver or brain
-Active, known, or suspected autoimmune disease or infection
-Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

Study & Design

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