drugset / Trial / NCT03461952
Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe)
Phase 2
Terminated
4 enrolled
Canadian Cancer Trials Group
Bristol-Myers Squibb · collabCancer Research Institute, New York City · collabPersonal Genome Diagnostics · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and effectiveness of nivolumab alone or in combination with ipilimumab in patients with metastatic or unresectable tumors harbouring mutations in genes, POLE and POLD1. These mutations will be determined by plasma cfDNA. Nivolumab and ipilimumab have been given to patients across multiple types of cancer, and safe doses and schedules have been determined.
Timeline
- Start
- 2019-03-11
- Primary completion
- 2021-06-01
- Completion
- 2022-02-09
Outcome
Outcome not reported
Stopped (Enrollment): “cfDNA screening data found that the prevalence of POLE/POLD1 mutations was lower than expected. It was determined that there are no feasible options to amend this study in a fashion that would not be duplicative of other currently accruing trials.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |