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

ClinicalTrials.gov ID: NCT03461952

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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 Tumors Detected by a Blood Based Assay

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03461952
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Canadian Cancer Trials Group; Network
Enrollment: 4 participants

Conditions and interventions

Conditions

Advanced Solid Tumors

Interventions

Nivolumab Drug
Ipilimumab Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 11, 2019 (Actual)
Primary completion: Jun 1, 2021 (Actual)
Completion: Feb 9, 2022 (Actual)
Last update posted: Feb 22, 2024

2019 – 2022

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Columbia University Medical Center	New York	New York	10032	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03461952, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 22, 2024 · Synced Nov 12, 2026