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NCT03668119 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study of Pan Tumor, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
212
Enrollment target
20
Study locations

NCT03668119: Completed Phase 2 study of Pan Tumor, sponsored by Bristol-Myers Squibb.

NCT03668119 is a Phase 2 study of Pan Tumor that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 212 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03668119, a Phase 2 study of Pan Tumor, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
212 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

Primary Outcome

ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancin

Conditions Studied

Pan Tumor

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Other

  • Local Institution - 0078 - CABA
  • Local Institution - 0015 - CABA
  • Local Institution - 0119 - Córdoba
  • Local Institution - 0112 - Brussels
  • Local Institution - 0113 - Brussels

Texas

  • Local Institution - 0095 - Austin
  • Local Institution - 0094 - Dallas
  • Local Institution - 0090 - Houston
  • Texas Oncology - Northeast Texas - Tyler

Buenos Aires

  • Local Institution - 0016 - Ciudad Autonoma Beunos Aires
  • Local Institution - 0087 - Ciudad Autónoma de Buenos Aires

New South Wales

  • Local Institution - 0118 - St Leonards
  • Local Institution - 0062 - Sydney

California

  • John Wayne Cancer Center - Santa Monica

Colorado

  • Rocky Mountain Cancer Centers - Denver

Minnesota

  • Local Institution - 0093 - Minneapolis

New York

  • Broome Oncology - Johnson City

Trial Details

FieldValue
Enrollment Target 212 participants
Start Date 2018-10-31
Est. Completion 2023-08-02
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT03668119 record still lists

NCT03668119 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).

The record links to 1 condition, with Pan Tumor appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT03668119 names 20 study sites across 11 states, led by Other, Texas, Buenos Aires.

Frequently Asked Questions

What is clinical trial NCT03668119 about?

NCT03668119 is a clinical study titled "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)". The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

What is the current status of trial NCT03668119?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2018-10-31. Estimated completion is 2023-08-02.

What conditions does trial NCT03668119 study?

This clinical trial studies the following conditions: Pan Tumor.

What interventions are being tested in trial NCT03668119?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03668119?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03668119 being conducted?

This trial has 20 study locations across California, Colorado, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT03668119's enrollment target sits among peer trials

212 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03668119, the US trial registry maintained by the National Library of Medicine. NCT03668119 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.