NCT03461952

Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe)

A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination With Ipilimumab for the Treatment of Patients With Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants in this study have been diagnosed with metastatic or unresectable solid tumors that have a mutation in POLE and/or POLD1. Nivolumab alone or in conjunction with ipilimumab is predicted to be effective against tumors with POLE and/or POLD1 mutations as these genetic changes cause increased rates of mutations in the DNA of tumor cells. These high mutation rates have been associated with response to immunotherapy agents such as nivolumab and ipilimumab.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Nivolumab	240mg
DRUG	Ipilimumab	1mg/kg

Timeline

• Start date: 2019-03-11
• Primary completion: 2021-06-01
• Completion: 2022-02-09
• First posted: 2018-03-12
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study