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Triple-Drug immunotherapy cocktail shows promise in advanced tumors

NCT ID NCT03459222

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested whether combining the experimental drug relatlimab with other immunotherapies (nivolumab plus either BMS-986205 or ipilimumab) is safe and can shrink tumors in people with advanced solid cancers. A total of 229 participants with various incurable, advanced tumors were enrolled. The main goals were to check for serious side effects and to see how many patients had their tumors shrink or stabilize.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
relatlimab (an experimental immunotherapy) combined with nivolumab, BMS-986205, or ipilimumab
What this could lead to
If successful, this could point toward new combination immunotherapy options for people with advanced cancers that are hard to treat.
What could go wrong
This is an early-phase trial focused on safety, so it is too soon to know if these combinations will work better than existing treatments. Side effects from combining multiple immunotherapies can be severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

229 people

The number who actually took part.

Started

May 2018

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1 * Available tumor tissue for biomarker analysis * Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1 Exclusion Criteria: * Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease * History of interstitial lung disease / pneumonitis * Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancer

Contacts and locations

Locations

  • Local Institution - 0001

    Germantown, Tennessee, 38138, United States

  • Local Institution - 0003

    Aurora, Colorado, 80045, United States

  • Local Institution - 0004

    Baltimore, Maryland, 21231, United States

  • Local Institution - 0005

    St Louis, Missouri, 63110, United States

  • Local Institution - 0006

    Duarte, California, 91010, United States

  • Local Institution - 0007

    Zurich, 8091, Switzerland

  • Local Institution - 0008

    Lausanne, 1011, Switzerland

  • Local Institution - 0009

    Naples, 80131, Italy

  • Local Institution - 0010

    Forlì, 47014, Italy

  • Local Institution - 0011

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0012

    Wollstonecraft, New South Wales, 2065, Australia

  • Local Institution - 0013

    Headington, OX3 7LE, United Kingdom

  • Local Institution - 0014

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Local Institution - 0015

    Villejuif, 94800, France

  • Local Institution - 0016

    Toulouse, 31059, France

  • Local Institution - 0017

    Marseille, 13385, France

  • Local Institution - 0018

    Madrid, 28050, Spain

  • Local Institution - 0019

    Barcelona, 08036, Spain

  • Local Institution - 0020

    Pamplona, 31008, Spain

  • Local Institution - 0021

    Madrid, 28041, Spain

  • Local Institution - 0022

    Málaga, 29011, Spain

  • Local Institution - 0023

    Rome, 00144, Italy

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