Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations — IMPACT  

Solid Tumor Clinical Trial

Official title: IMPACT: Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This study investigates the efficacy of checkpoint inhibitor immunotherapy in patients with metastatic cancer with CDK12 mutations. The study includes three cohorts: Cohort A consists of metastatic prostate cancer patients being treated with combination nivolumab and ipilimumab treatment followed by monotherapy nivolumab treatment. Cohort B consists of other solid tumor patients being treated with combination nivolumab and ipilimumab treatment followed by monotherapy nivolumab treatment. As of an amendment approved 03FEB2021 a third cohort was added, Cohort C, which consists of metastatic prostate cancer patients being treated with monotherapy nivolumab treatment.

As of an amendment approved 21JUN2020 the maximum duration of treatment, as well as the anticipated timing for some of the studies outcome measures, were updated from 52 weeks to 104 weeks. ;

Related Conditions & MeSH terms

• Metastatic Cancer
• Metastatic Castration Resistant Prostate Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Prostatic Neoplasms
• Solid Tumor

• NCT number: NCT03570619
• Study type: Interventional
• Source: University of Michigan Rogel Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 14, 2018
• Completion date: December 2024