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Long-term safety evaluation of nivolumab and other cancer therapies

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

Phase 2 Interventional Bristol-Myers Squibb · NCT03899155

This study is testing the long-term safety of nivolumab alone and with other cancer treatments for patients who have responded well to previous therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsnivolumab
Locations399 sites (Huntsville, Alabama and 398 other locations)
Trial IDNCT03899155 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term safety of nivolumab monotherapy and its combinations with other cancer therapies across various tumor types. Participants who have previously been part of a parent study and are eligible for continued treatment will be enrolled. The study will focus on patients who have shown a long-lasting response or are eligible for treatment rechallenge. The interventions include nivolumab, ipilimumab, cabozantinib, trametinib, and relatlimab.

Who should consider this trial

Good fit: Ideal candidates are patients who have previously participated in a parent study and are eligible for continued treatment with nivolumab or its combinations.

Not a fit: Patients who are not receiving clinical benefit from the parent study or do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of nivolumab and its combinations for cancer patients.

How similar studies have performed: Other studies have shown success with nivolumab and its combinations, indicating a promising approach in cancer treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Signed Written Informed Consent.
* Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
* On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
* WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.

Exclusion Criteria

* Participant is not eligible for study treatment per the Parent Study eligibility criteria.
* Participants not receiving clinical benefit as assessed by the Investigator.
* Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.
* Other protocol-defined Inclusion/Exclusion Criteria apply

Where this trial is running

Huntsville, Alabama and 398 other locations

+349 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions CancerRolloverpan-tumor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.