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

NCT04895709 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA052-0022023-503651-10U1111-1265-4508
• Study Type: interventional
• Target: 949
• Locations: 9 countries
• Sites: 48

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 or docetaxel 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; Non-Small-Cell Lung Cancer; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell; Urothelial Carcinoma; Pancreatic Adenocarcinoma; Melanoma; Ovarian Neoplasms; Triple Negative Breast Neoplasms; Microsatellite Stable Colorectal Cancer; Gastric/Gastroesophageal Junction Adenocarcinoma

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

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events (AEs)

  Up to 120 weeks

• Incidence of serious adverse events (SAEs)

  Up to 120 weeks

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

  Up to 120 weeks

• Incidence of AEs leading to discontinuation

  Up to 120 weeks

• Incidence of AEs leading to death

  Up to 120 weeks

Secondary Outcomes (19)

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

  Up to 120 weeks

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

  Up to 120 weeks

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

  Up to 120 weeks

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

  Up to 120 weeks

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

  Up to 120 weeks

Study Arms (7)

Part 1A: BMS-986340 Dose Escalation

EXPERIMENTAL

Drug: BMS-986340

Part 2A: BMS-986340 Dose Expansion

EXPERIMENTAL

Drug: BMS-986340

Part 1B: BMS-986340 + Nivolumab Dose Escalation

EXPERIMENTAL

Drug: BMS-986340; Drug: BMS-936558-01

Part 2B: BMS-986340 + Nivolumab Dose Expansion

EXPERIMENTAL

Drug: BMS-986340; Drug: BMS-936558-01

Part 1C: BMS-986340 + Docetaxel Dose Escalation

EXPERIMENTAL

Drug: BMS-986340; Drug: Docetaxel

Part 1A-J: BMS-986340 Dose Escalation

EXPERIMENTAL

Drug: BMS-986340

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

EXPERIMENTAL

Drug: BMS-986340; Drug: BMS-936558-01

Interventions

BMS-986340 DRUG

Specified dose on specified days

Part 1A-J: BMS-986340 Dose Escalation; Part 1A: BMS-986340 Dose Escalation; Part 1B-J: BMS-986340 + Nivolumab Dose Escalation; Part 1B: BMS-986340 + Nivolumab Dose Escalation; Part 1C: BMS-986340 + Docetaxel Dose Escalation; Part 2A: BMS-986340 Dose Expansion; Part 2B: BMS-986340 + Nivolumab Dose Expansion

BMS-936558-01 DRUG

Specified dose on specified days

Also known as: Nivolumab

Part 1B-J: BMS-986340 + Nivolumab Dose Escalation; Part 1B: BMS-986340 + Nivolumab Dose Escalation; Part 2B: BMS-986340 + Nivolumab Dose Expansion

Docetaxel DRUG

Specified dose on specified days

Part 1C: BMS-986340 + Docetaxel Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (48)

Community Cancer Institute

Clovis, California, 93611, United States

RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Local Institution - 0006

New York, New York, 10032, United States

COMPLETED

Local Institution - 0002

New York, New York, 10065, United States

COMPLETED

Providence Cancer Center Oncology and Hematology Care- Eastside

Portland, Oregon, 97213, United States

RECRUITING

Local Institution - 0063

Nashville, Tennessee, 37067, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

RECRUITING

Cabrini Hospital - Malvern

Malvern, Victoria, 3144, Australia

RECRUITING

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

RECRUITING

One Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6X 1E8, Canada

RECRUITING

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Hamilton Health Sciences-Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

RECRUITING

Local Institution - 0009

Toronto, Ontario, M5G 2M9, Canada

COMPLETED

Centre Hospitalier de luniversite de Montreal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, K1H 8L6, Canada

RECRUITING

Local Institution - 0067

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

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

Dresden, 01307, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

RECRUITING

Rabin Medical Center

Petah Tikva, Central District, 4941492, Israel

RECRUITING

Local Institution - 0035

Ramat Gan, Central District, 5265601, Israel

WITHDRAWN

Sheba Medical Center

Ramat Gan, Central District, 5265601, Israel

RECRUITING

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906, Israel

RECRUITING

Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

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

Candiolo, Torino, 10060, Italy

RECRUITING

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

Milan, 20133, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, 80131, Italy

RECRUITING

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

Roma, 00168, Italy

RECRUITING

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

Siena, 53100, Italy

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

RECRUITING

Institut Catalan d Oncologia (ICO) - Badalona

Badalona, Barcelona [Barcelona], 08916, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

Madrid, 28040, Spain

RECRUITING

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

Madrid, 28050, Spain

RECRUITING

Clinica Universidad de Navarra-oNCOLOGY

Pamplona, 31008, Spain

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

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

Interventions

Nivolumab; Docetaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 20, 2021
• Study Start: May 27, 2021
• Primary Completion (Estimated): July 7, 2028
• Study Completion (Estimated): July 7, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (7); AU (6); CA (6); JP (1); DE (5); US (11); CN (1); IT (6); IL (5)