Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

  • Interventional
  • Recruiting
  • NCT02985957
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to determine whether Nivolumab plus Ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior Docetaxel-containing regimen.

Gender
Male

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

        Inclusion Criteria:

         - Evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria) on previous bone, CT and/or MRI scan.

         - Eastern Cooperative Oncology Group (ECOG) performance status 0-1

         - 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)

         - Participants with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment

        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)

         - Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment.

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT02985957

IRB#IRB17-0938

Lead SponsorBristol-Myers Squibb

Lead PhysicianAkash Patnaik

Collaborator(s)N/A

EligibilityMale
18 Years and up
Recruiting