Recruiting
Phase 1
Phase 2

BMS-986340, Nivolumab, Docetaxel

Sponsor:

Bristol-Myers Squibb

Code:

NCT04895709

Conditions

Cervical Cancer

Gastric/Gastroesophageal Junction Adenocarcinoma

Microsatellite Stable Colorectal Cancer

Non-Small-Cell Lung Cancer

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986340

BMS-936558-01

Docetaxel

Pumitamig

Study Details

Brief 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. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Conditions

Cervical Cancer

Gastric/Gastroesophageal Junction Adenocarcinoma

Microsatellite Stable Colorectal Cancer

Non-Small-Cell Lung Cancer

Squamous Cell Carcinoma of Head and Neck

Study ID

NCT04895709

Start date

May 27, 2021

Status verified date

Aug, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1109 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A: BMS-986340 Dose Escalation

experimental: Part 2A: BMS-986340 Dose Expansion

experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation

experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion

experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation

experimental: Part 1A-J: BMS-986340 Dose Escalation

experimental: Part 1B-J: BMS-986340 + Nivolumab Dose Escalation

experimental: Part 2C: BMS-986340 + Docetaxel Dose Expansion

experimental: Part 2D: BMS-986340 + Pumitamig Dose Expansion

Interventions

BMS-986340

Specified dose on specified days

BMS-936558-01

Specified dose on specified days

Docetaxel

Specified dose on specified days

Pumitamig

Specified dose on specified days

Primary outcome measure

  • Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to either 21 or 28 days ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 120 weeks ]
  • Number of deaths [ Time Frame: Up to 120 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Community Cancer Institute

Recruiting

Clovis, California, United States, 93611

Contacts

Uzair Chaudhary, Site 0032

559-387-1600

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Anthony El-Khoueiry, Site 0041

323-865-3967

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Carlos Becerra, Site 0050

949-764-8222

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Douglas Laux, Site 0062

319-356-1032

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Martin Gutierrez, Site 0007

551-996-5863

Providence Cancer Center Oncology and Hematology Care- Eastside

Recruiting

Portland, Oregon, United States, 97213

Contacts

Rom Leidner, Site 0001

503-215-5696

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Jordan Berlin, Site 0052

615-936-1796

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Maen Abdelrahim, Site 0061

346-241-5495

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6X 1E8

Contacts

Quincy Chu, Site 0027

7804328248

Hamilton Health Sciences-Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V5C2

Contacts

Sebastien Hotte, Site 0029

905-387-9495

Centre Hospitalier de luniversite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Rahima Jamal, Site 0015

51489080008444

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

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
  • Docetaxel
  • Pumitamig

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-17.