Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 14, 2018

Primary Completion Date

December 22, 2022

Study Completion Date

March 26, 2024

Conditions
Metastatic Castration Resistant Prostate CancerMetastatic CancerSolid Tumor
Interventions
DRUG

Nivolumab

"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."

DRUG

Ipilimumab

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.

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center, New York

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

33612

H. Lee. Moffitt Cancer Center & Research Institute, Inc., Tampa

48109

University of Michigan Rogel Cancer Center, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

63110

Siteman Cancer Center at Washington University, St Louis

92093

University of California San Diego, Moores Cancer Center, San Diego

94158

University of California San Francisco/Helen Diller Family Comprehensive Cancer Center, San Francisco

All Listed Sponsors
collaborator

Memorial Sloan Kettering Cancer Center

OTHER

collaborator

University of California, San Francisco

OTHER

lead

University of Michigan Rogel Cancer Center

OTHER

NCT03570619 - Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations | Biotech Hunter | Biotech Hunter