drugset / Trial / NCT03572478

Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer

NCT03572478

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 1/phase 2a study of the combination of immune checkpoint inhibitor (nivolumab) in combination with the PARP inhibitor (rucaparib) for patients with metastatic castration resistant prostate cancer (mCRPC) and metastatic/recurrent endometrial cancer. In the phase 1 portion, the safety of the combination dosing will be determined. If the combination dosing is determined to be safe and feasible, the study will move onto phase 2a. In the phase 2a portion, participants will be randomized to receive either: rucaparib alone, nivolumab alone, or combination therapy (rucaparib and nivolumab).

Timeline

Start
2018-08-14
Primary completion
2020-02-29
Completion
2020-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Rucaparib Small molecule 600 mg Oral