EUCTR2017-001626-17-ES
Active, not recruiting
Phase 1
A Phase 2 Study of Nivolumab in Combination with Either Rucaparib, Docetaxel, or Enzalutamide in Men with Castration-resistant Metastatic Prostate Cancer - CheckMate 9KD: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9KD
ConditionsCastration-resistant Metastatic Prostate CancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Castration-resistant Metastatic Prostate Cancer
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologic confirmation of adenocarcinoma of the prostate
- •\- Evidence of metastatic disease
- •\- Ongoing androgen deprivation therapy (ADT) with a gonadotropin\-releasing hormone (GnRH) analogue or bilateral orchiectomy
- •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 150
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 150
Exclusion Criteria
- •\- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
- •\- Participants with active brain metastases
- •\- Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment
Outcomes
Primary Outcomes
Not specified
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