Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations

Part of paid clinical trials in San Diego, California.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03570619
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Cancer
  • Metastatic Castration Resistant Prostate Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy.
  • Ipilimumab — DRUG
    Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy.

Study Details

This study will attempt to determine the efficacy of checkpoint inhibitor immunotherapy with nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy in patients with metastatic prostate cancer and other tumor solid tumor histologies harboring loss of CDK12 function as well as monotherapy nivolumab treatment in patient with metastatic prostate cancer harboring loss of CDK12 function.

Key Dates

Start date
Dec 14, 2018
Status verified
Apr 2025
Primary completion
Dec 22, 2022
Completion
Mar 26, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metastatic CRPC
    Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A.
  • Experimental: Solid Tumors (non-prostate)
    Patients with all other metastatic subtypes will be enrolled in cohort B
  • Experimental: Metastatic CRPC with Monotherapy
    Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed.

Primary Outcome Measure

The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment. [ Time Frame: Up to 24 months post treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California San Diego, Moores Cancer CenterSan DiegoCalifornia92093-
University of California San Francisco/Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
H. Lee. Moffitt Cancer Center & Research Institute, Inc.TampaFlorida33612-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Karmanos Cancer InstituteDetroitMichigan48201-
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in San Diego, CA

By research site
University of California San Diego, Moores Cancer Center· San Diego, CAUniversity of California San Francisco/Helen Diller Family Comprehensive Cancer Center· San Francisco, CAH. Lee. Moffitt Cancer Center & Research Institute, Inc.· Tampa, FLJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIKarmanos Cancer Institute· Detroit, MI

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