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Recruiting

NCT Number: NCT03899155

Pan Tumor Rollover Study

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Recruiting

Interested in participating?

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0199, Berazategui, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

Specified dose on specified days

Other names: BMS-936558-01

Ipilimumab

Drug

Specified dose on specified days

Cabozantinib

Drug

Specified dose on specified days

Trametinib

Drug

Specified dose on specified days

Relatlimab

Drug

Specified dose on specified days

Other names: BMS-986016-01

Nivolumab + Relatlimab

Drug

Specified dose on specified days

Other names: BMS-986213

Capecitabine

Drug

Specified dose on specified days

Bevacizumab

Drug

Specified dose on specified days

Temozolomide

Drug

Specified dose on specified days

Rucaparib

Drug

Specified dose on specified days

Daratumumab

Drug

Specified dose on specified days

Regorafinib

Drug

Specified dose on specified days

Leucovorin

Drug

Specified dose on specified days

Fluorouracil

Drug

Specified dose on specified days

Oxaliplatin

Drug

Specified dose on specified days

Enzalutamide

Drug

Specified dose on specified days

Sunitinib

Drug

Specified dose on specified days

Pemetrexed

Drug

Specified dose on specified days

Pembrolizumab

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  2. Incidence of drug related AEs

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  3. Incidence of AEs leading to Discontinuation

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  4. Incidence of Serious Adverse Events (SAEs)

    Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment

  5. Incidence of Select AEs

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  6. Incidence of Immune-Mediated AEs

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  7. Incidence of Death

    Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Clovis Oncology, Inc.
  • Exelixis
  • Janssen Pharmaceuticals
  • Novartis

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2019
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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