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

Official Title

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 Tumours Detected by a Blood Based Assay

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 tumours 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.

Trial Description

Primary Outcome:

  • Objective Response Rate by RECIST 1.1
Secondary Outcome:
  • Efficacy as measured by objective response rate
  • Duration of response
  • Number and severity of adverse events using CTCAE 5.0
  • Correlation between POLE or POLD1 mutations in tumour and POLE or POLD1 mutations in blood
  • To evaluate response by iRECIST
Participants in this study have been diagnosed with metastatic or unresectable solid tumours that have a mutation in POLE and/or POLD1. Nivolumab alone or in conjunction with ipilimumab is predicted to be effective against tumours with POLE and/or POLD1 mutations as these genetic changes cause increased rates of mutations in the DNA of tumour cells. These high mutation rates have been associated with response to immunotherapy agents such as nivolumab and ipilimumab.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society