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Completed Phase 2 Interventional Results available

A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

ClinicalTrials.gov ID: NCT03668119

Public ClinicalTrials.gov record NCT03668119. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 8:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Study identification

NCT ID
NCT03668119
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
212 participants

Conditions and interventions

Conditions

Interventions

  • Nivolumab Biological
  • Ipilimumab Biological

Biological

Eligibility (public fields only)

Age range
12 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
Oct 30, 2018
Primary completion
May 2, 2022
Completion
Aug 1, 2023
Last update posted
Aug 27, 2024

2018 – 2023

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
John Wayne Cancer Center Santa Monica California 90404
Rocky Mountain Cancer Centers Denver Colorado 80218
Local Institution - 0093 Minneapolis Minnesota 55404
Broome Oncology Johnson City New York 13790
Duke Cancer Institute Durham North Carolina 27710
Local Institution - 0079 Portland Oregon 97239
Local Institution - 0095 Austin Texas 78731
Local Institution - 0094 Dallas Texas 75231
Local Institution - 0090 Houston Texas 77030
Texas Oncology - Northeast Texas Tyler Texas 75702

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 50 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03668119, 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 Aug 27, 2024 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03668119 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →