EUCTR2016-001928-54-ES
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 495
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Not specified
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