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New drug combo trial aims to fight advanced cancers

NCT ID NCT04895709

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 4 times

Summary

This study tests a new drug called BMS-986340, alone or with other cancer treatments, in people with advanced solid tumors like lung, colon, or breast cancer. The goal is to find safe doses and check for side effects. About 1,100 adults with tumors that have worsened after standard therapy will take part.

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

About 1,109 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Aug 2031

An estimate. End dates often move.

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 * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable. * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Radiographically documented progressive disease on or after the most recent therapy. * Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated. * Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant. Exclusion Criteria * Women who are pregnant or breastfeeding. * Primary central nervous system (CNS) malignancy. * Untreated CNS metastases. * Leptomeningeal metastases. * Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment. * Active, known, or suspected autoimmune disease. * Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment. * Prior organ or tissue allograft. * Uncontrolled or significant cardiovascular disease. * Major surgery within 4 weeks of study drug administration. * History of or with active interstitial lung disease or pulmonary fibrosis. * Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cervical cancer colorectal cancer colorectal carcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma melanoma non-small cell lung carcinoma ovarian cancer ovarian neoplasm pancreatic adenocarcinoma renal cell adenocarcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck transitional cell carcinoma triple-negative breast carcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Carcinoma, renal cell Cervical cancer Gastric/gastroesophageal junction adenocarcinoma Melanoma Microsatellite-stable colorectal cancer Non-small cell lung cancer Ovarian neoplasms Pancreatic adenocarcinoma Squamous cell carcinoma of head and neck Triple negative breast neoplasms Urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Blacktown Hospital

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • Cabrini Hospital - Malvern

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Centre Hospitalier de luniversite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • Clinica Universidad de Navarra-oNCOLOGY

    RECRUITING

    Pamplona, 31008, Spain

  • Community Cancer Institute

    RECRUITING

    Clovis, California, 93611, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6X 1E8, Canada

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    RECRUITING

    Roma, 00168, Italy

  • Hamilton Health Sciences-Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V5C2, Canada

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Humanitas

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Institut Catalan d Oncologia (ICO) - Badalona

    RECRUITING

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    RECRUITING

    Naples, 80131, Italy

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    RECRUITING

    Candiolo, Torino, 10060, Italy

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Local Institution - 0002

    COMPLETED

    New York, New York, 10065, United States

  • Local Institution - 0006

    COMPLETED

    New York, New York, 10032, United States

  • Local Institution - 0009

    COMPLETED

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0016

    COMPLETED

    Ottawa, K1H 8L6, Canada

  • Local Institution - 0030

    COMPLETED

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Local Institution - 0035

    WITHDRAWN

    Ramat Gan, Central District, 5265601, Israel

  • Local Institution - 0044

    COMPLETED

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Local Institution - 0063

    WITHDRAWN

    Nashville, Tennessee, 37204, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • One Clinical Research

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Queensland, 4102, Australia

  • Providence Cancer Center Oncology and Hematology Care- Eastside

    RECRUITING

    Portland, Oregon, 97213, United States

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Northern District, 3109601, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5265601, Israel

  • Sourasky Medical Center

    RECRUITING

    Tel Aviv, Tell Abīb, 6423906, Israel

  • St Vincent's Hospital

    RECRUITING

    Melbourne, Victoria, 3065, Australia

  • USC/Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97078, Germany

  • Universitatsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica

    RECRUITING

    Siena, 53100, Italy

More trials for these conditions

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