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Cervical CancerPhase 1/2NCT04895709

A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

A Phase 1/2 study testing BMS-986340, BMS-936558-01 and Docetaxel in people with Cervical Cancer and Gastric/Gastroesophageal Junction Adenocarcinoma, run by Bristol-Myers Squibb at 47 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMS-986340, BMS-936558-01 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,109 participants
Where
47 sitesin 8 countries
Study dates
27 May 2021to 31 Aug 2031
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

47 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

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

47 sites in 8 countries

United States11 sites, 8 recruiting

  • Community Cancer Institute

    Clovis, California, 93611

    Uzair Chaudhary, Site 0032, 559-387-1600

    Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

    Martin Gutierrez, Site 0007, 551-996-5863

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Maen Abdelrahim, Site 0061, 346-241-5495

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Douglas Laux, Site 0062, 319-356-1032

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Anthony El-Khoueiry, Site 0041, 323-865-3967

    Recruiting

  • Local Institution - 0063

    Nashville, Tennessee, 37204

    Withdrawn

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Jordan Berlin, Site 0052, 615-936-1796

    Recruiting

  • Local Institution - 0006

    New York, New York, 10032

    Completed

  • Local Institution - 0002

    New York, New York, 10065

    Completed

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Carlos Becerra, Site 0050, 949-764-8222

    Recruiting

  • Providence Cancer Center Oncology and Hematology Care- Eastside

    Portland, Oregon, 97213

    Rom Leidner, Site 0001, 503-215-5696

    Recruiting

Other trials in United States

Spain7 sites, 7 recruiting

  • Institut Catalan d Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona], 08916

    Cinta Hierro Carbo, Site 0014, 34934978925

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

    Elena Garralda Cabanas, Site 0049, 349327460004910

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

    Luis Paz-Ares Rodriguez, Site 0047, 0034913908922

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

    Madrid, 28040

    Victor Moreno Garcia, Site 0013, 915504800ext2805

    Recruiting

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

    Madrid, 28050

    Emiliano Calvo, Site 0011, +34934894304

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

    Javier Garcia Corbacho, Site 0048, 951032250

    Recruiting

  • Clinica Universidad de Navarra-oNCOLOGY

    Pamplona, 31008

    Ignacio Melero Bermejo, Site 0012, 34948255400

    Recruiting

Other trials in Spain

Australia6 sites, 6 recruiting

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

    Adnan Nagrial, Site 0057, +61 02 86705071

    Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

    Aaron Hansen, Site 0054, 61731765564

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    Abhijit Pal, Site 0058, 61287389744

    Recruiting

  • Cabrini Hospital - Malvern

    Malvern, Victoria, 3144

    Shehara Mendis, Site 0053, (03)95083434

    Recruiting

  • St Vincent's Hospital

    Melbourne, Victoria, 3065

    Melissa Moore, Site 0055, 61392313155

    Recruiting

  • One Clinical Research

    Nedlands, Western Australia, 6009

    Muhammad Khattak, Site 0056, +61 08 6279 9466

    Recruiting

Other trials in Australia

Canada6 sites, 3 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6X 1E8

    Quincy Chu, Site 0027, 7804328248

    Recruiting

  • Hamilton Health Sciences-Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2

    Sebastien Hotte, Site 0029, 905-387-9495

    Recruiting

  • Centre Hospitalier de luniversite de Montreal

    Montreal, Quebec, H2X 0A9

    Rahima Jamal, Site 0015, 51489080008444

    Recruiting

  • Local Institution - 0016

    Ottawa, K1H 8L6

    Completed

  • Local Institution - 0009

    Toronto, Ontario, M5G 2M9

    Completed

  • Local Institution - 0030

    Vancouver, British Columbia, V5Z 4E6

    Completed

Other trials in Canada

Italy6 sites, 6 recruiting

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

    Candiolo, Torino, 10060

    Vanesa Gregorc, Site 0033, 390119933250

    Recruiting

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

    Milan, 20133

    Filippo De Braud, Site 0024, 390223903066

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

    Paolo Ascierto, Site 0034, 390815903431

    Recruiting

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

    Roma, 00168

    Gennaro Daniele, Site 0040, +390630153446

    Recruiting

  • Humanitas

    Rozzano, Milano, 20089

    Matteo Simonelli, Site 0023, +390282244559

    Recruiting

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

    Siena, 53100

    Michele Maio, Site 0025, 390577586335

    Recruiting

Other trials in Italy

Germany5 sites, 4 recruiting

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

    Dresden, 01307

    Martin Wermke, Site 0010, +493514587566

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Stefan Kasper-Virchow, Site 0018, 00492017233449

    Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

    Martin Sebastian, Site 0020, +496963016217

    Recruiting

  • Local Institution - 0044

    Ulm, Baden-Wurttemberg, 89081

    Completed

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

    Cyrus Sayehli, Site 0019, 4993120140964

    Recruiting

Other trials in Germany

Israel5 sites, 4 recruiting

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

    Talia Shentzer Kutiel, Site 0039, 97247776700

    Recruiting

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

    Salomon Stemmer, Site 0036, 97239378076

    Recruiting

  • Local Institution - 0035

    Ramat Gan, Central District, 5265601

    Withdrawn

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

    Tamar Beller, Site 0038, 97235302542

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906

    Ravit Geva, Site 0037, 97236973082

    Recruiting

Other trials in Israel

Japan1 site, 1 recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Yasutoshi Kuboki, Site 0064, 81471331111

    Recruiting

Other trials in Japan

About this study

Official title: A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Being tested
BMS-986340, BMS-936558-01, Docetaxel, Pumitamig
Keywords
BMS-986340, Cervical Cancer, CRC, First-in-human, GEJ, Gastric/Gastroesophageal Junction Adenocarcinoma, HNSCC, Microsatellite Stable Colorectal Cancer, MSS CRC, Nivolumab, Non-Small-Cell Lung Cancer, NSCLC, SCCHN, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms
Medical subject headings
Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986340Drug

    Specified dose on specified days

  • BMS-936558-01Drug

    Also called Nivolumab

    Specified dose on specified days

  • DocetaxelDrug

    Specified dose on specified days

  • PumitamigDrug

    Also called BMS-986545, BNT327

    Specified dose on specified days

Study groups in NCT04895709
Study groupRoleWhat they receive
Part 1A: BMS-986340 Dose EscalationExperimentalNot described
Receives: Drug: BMS-986340
Part 2A: BMS-986340 Dose ExpansionExperimentalNot described
Receives: Drug: BMS-986340
Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimentalNot described
Receives: Drug: BMS-986340; Drug: BMS-936558-01
Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimentalNot described
Receives: Drug: BMS-986340; Drug: BMS-936558-01
Part 1C: BMS-986340 + Docetaxel Dose EscalationExperimentalNot described
Receives: Drug: BMS-986340; Drug: Docetaxel
Part 1A-J: BMS-986340 Dose EscalationExperimentalNot described
Receives: Drug: BMS-986340
Part 1B-J: BMS-986340 + Nivolumab Dose EscalationExperimentalNot described
Receives: Drug: BMS-986340; Drug: BMS-936558-01
Part 2C: BMS-986340 + Docetaxel Dose ExpansionExperimentalNot described
Receives: Drug: BMS-986340; Drug: Docetaxel
Part 2D: BMS-986340 + Pumitamig Dose ExpansionExperimentalNot described
Receives: Drug: BMS-986340; Drug: Pumitamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Measured: Up to 120 weeks

  2. Incidence of serious adverse events (SAEs)

    Measured: Up to 120 weeks

  3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

    Measured: Up to either 21 or 28 days

  4. Incidence of AEs leading to discontinuation

    Measured: Up to 120 weeks

  5. Number of deaths

    Measured: Up to 120 weeks

Secondary outcomes (24)

  1. Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)

    Measured: Up to 120 weeks

  2. PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)

    Measured: Up to 120 weeks

  3. PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))

    Measured: Up to 120 weeks

  4. PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)

    Measured: Up to 120 weeks

  5. PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)

    Measured: Up to 120 weeks

  6. PK parameters of BMS-986340 administered in combination with docetaxel: Cmax

    Measured: Up to 120 weeks

  7. PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)

    Measured: Up to 120 weeks

  8. PK parameters of BMS-986340 administered in combination with docetaxel: Tmax

    Measured: Up to 120 weeks

  9. PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Measured: Up to 120 weeks

  10. PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)

    Measured: Up to 120 weeks

  11. PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)

    Measured: Up to 120 weeks

  12. PK parameters of BMS-986340 administered in combination with docetaxel: Ctau

    Measured: Up to 120 weeks

  13. PK parameters of BMS-986340 administered in combination with pumitamig: Cmax

    Measured: Up to 120 weeks

  14. PK parameters of BMS-986340 administered in combination with pumitamig: Tmax

    Measured: Up to 120 weeks

  15. PK parameters of BMS-986340 administered in combination with pumitamig: AUC(TAU)

    Measured: Up to 120 weeks

  16. PK parameters of BMS-986340 administered in combination with pumitamig: Ctau

    Measured: Up to 120 weeks

  17. Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy

    Measured: Up to 120 weeks

  18. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab

    Measured: Up to 120 weeks

  19. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel

    Measured: Up to 120 weeks

  20. Incidence of anti-drug antibodies to BMS-986340 when administered in combination with pumitamig

    Measured: Up to 120 weeks

  21. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Measured: At 6 months, 12 months

  22. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Measured: At 6 months, 12 months

  23. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Measured: At 6 months, 12 months

  24. Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Measured: At 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start27 May 2021
  3. Primary completion31 Aug 2031 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
1,109 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895709
Sponsor's protocol ID
CA052-002
Other IDs
2023-503651-10, U1111-1265-4508, 2023
Status last verified
Aug 2026
First submitted
19 May 2021
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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