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

Part of paid clinical trials in New York, New York.

Sponsor
Canadian Cancer Trials Group
Study ID
NCT03461952
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 11, 2019
Status verified
Feb 2024
Primary completion
Jun 1, 2021
Completion
Feb 9, 2022

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    240mg Q2W
  • Experimental: Nivolumab + Ipilimumab
    Nivolumab 240mg Q2Wk + Ipilimumab 1mg/kg Q6W

Primary Outcome Measure

Objective Response Rate by RECIST 1.1 [ Time Frame: 36 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NY

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