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

NCT03461952 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-02-22

Study results available
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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.

Conditions

Interventions

DRUG

Nivolumab

240mg

DRUG

Ipilimumab

1mg/kg

Sponsors & Collaborators

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Personal Genome Diagnostics

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Naiyer Rizvi · Thoracic Oncology and Immunotherapeutics, Columbia University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2021-06-01
Completion
2022-02-09
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461952 on ClinicalTrials.gov