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New combo therapy shows promise for Hard-to-Treat cancers

NCT ID NCT01968109

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental drug called BMS-986016 (anti-LAG-3) alone or combined with nivolumab in people with advanced solid tumors that had spread or couldn't be removed by surgery. It included several cancer types like lung, stomach, liver, kidney, bladder, head and neck, and melanoma. The main goals were to check safety and see if the treatment could shrink tumors.

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

1,482 people

The number who actually took part.

Started

Nov 2013

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

12 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: * For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4. * For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC * Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts. * ECOG performance status between 0 and 2 * At least 1 lesion with measurable disease at baseline * Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy) Exclusion Criteria: * Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease * Autoimmune disease * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent * Uncontrolled CNS metastases Other protocol defined inclusion/exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

cervical cancer colorectal cancer gastric cancer head and neck squamous cell carcinoma hepatocellular carcinoma melanoma Neoplasms by Site non-small cell lung carcinoma ovarian cancer renal cell carcinoma urinary bladder carcinoma

As listed by the trial registrant

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

Neoplasms by site

Contacts and locations

Locations

  • Local Institution - 0001

    Boston, Massachusetts, 02215, United States

  • Local Institution - 0002

    Portland, Oregon, 97213, United States

  • Local Institution - 0003

    Chicago, Illinois, 60637, United States

  • Local Institution - 0004

    Baltimore, Maryland, 21287, United States

  • Local Institution - 0005

    New York, New York, 10065, United States

  • Local Institution - 0006

    Pamplona, 31008, Spain

  • Local Institution - 0007

    Essen, 45122, Germany

  • Local Institution - 0008

    Seattle, Washington, 98109, United States

  • Local Institution - 0010

    Pittsburgh, Pennsylvania, 15232-1305, United States

  • Local Institution - 0011

    Detroit, Michigan, 48201, United States

  • Local Institution - 0013

    Naples, 80131, Italy

  • Local Institution - 0014

    Milan, 20141, Italy

  • Local Institution - 0015

    Barcelona, 08035, Spain

  • Local Institution - 0016

    Zurich, 8091, Switzerland

  • Local Institution - 0017

    Lausanne, 1011, Switzerland

  • Local Institution - 0018

    Villejuif, 94800, France

  • Local Institution - 0019

    Oslo, 0379, Norway

  • Local Institution - 0020

    Herlev, 2730, Denmark

  • Local Institution - 0021

    Helsinki, Uusimaa, 00290, Finland

  • Local Institution - 0022

    London, Greater London, SW3 6JJ, United Kingdom

  • Local Institution - 0023

    Vienna, 1090, Austria

  • Local Institution - 0024

    Vienna, 1090, Austria

  • Local Institution - 0025

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Local Institution - 0026

    Toulouse, 31059, France

  • Local Institution - 0027

    London, Greater London, NW1 2PG, United Kingdom

  • Local Institution - 0028

    Copenhagen, 2100, Denmark

  • Local Institution - 0029

    North Sydney, New South Wales, 2060, Australia

  • Local Institution - 0031

    Brisbane, Queensland, 4120, Australia

  • Local Institution - 0032

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0033

    Melbourne, Victoria, 3000, Australia

  • Local Institution - 0034

    Manchester, M20 4BX, United Kingdom

  • Local Institution - 0035

    Padova, 35128, Italy

  • Local Institution - 0036

    Pierre-Bénite, 69495, France

  • Local Institution - 0037

    Nantes, 44093, France

  • Local Institution - 0038

    Marseille, 13385, France

  • Local Institution - 0039

    Southport, Queensland, 4215, Australia

  • Local Institution - 0040

    Heilbronn, 74078, Germany

  • Local Institution - 0041

    Würzburg, 97080, Germany

  • Local Institution - 0043

    La Jolla, California, 92093-0698, United States

  • Local Institution - 0044

    St Louis, Missouri, 63110, United States

  • Local Institution - 0045

    Houston, Texas, 77030, United States

  • Local Institution - 0046

    Málaga, 29010, Spain

  • Local Institution - 0047

    Allentown, Pennsylvania, 18103, United States

  • Local Institution - 0048

    Niles, Illinois, 60714, United States

  • Local Institution - 0049

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0050

    Québec, Quebec, G1J 1Z4, Canada

  • Local Institution - 0051

    Rochester, Minnesota, 55905-0001, United States

  • Local Institution - 0052

    Chuo-ku, Tokyo, 1040045, Japan

  • Local Institution - 0053

    Aurora, Colorado, 80045, United States

  • Local Institution - 0054

    Sunto-gun, Shizuoka, 4118777, Japan

  • Local Institution - 0055

    Nagoya, Aichi-ken, 4668560, Japan

  • Local Institution - 0057

    Dallas, Texas, 75246, United States

  • Local Institution - 0058

    Tampa, Florida, 33612, United States

  • Local Institution - 0059

    Sapporo, Hokkaido, 0608543, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.