Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04895709

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

Led by Bristol-Myers Squibb · Updated on 2026-04-13

949

Participants Needed

48

Research Sites

371 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fresh pre-treatment and on-treatment tumor biopsies must be provided for biomarker analysis
  • Measurable disease per RECIST v1.1 with at least one lesion accessible for biopsy (no fine needle, cytology, or bone biopsies)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Radiographically documented progressive disease after most recent therapy
  • Received standard-of-care treatments including available PD-(L)1 inhibitors effective for the tumor type
  • Have advanced or metastatic disease refractory to, not candidates for, or intolerant of existing clinical benefit therapies
  • For Part 1C, no prior docetaxel use for advanced/metastatic setting
Not Eligible

You will not qualify if you...

  • Women who are pregnant or breastfeeding
  • Primary central nervous system malignancy
  • Untreated CNS metastases
  • Leptomeningeal metastases
  • Concurrent malignancy needing treatment or history of prior malignancy active within 2 years before first dose
  • Active, known, or suspected autoimmune disease
  • Need for systemic corticosteroids within 14 days or other immunosuppressive drugs within 30 days before first dose
  • Prior organ or tissue transplant
  • Uncontrolled or significant cardiovascular disease
  • Major surgery within 4 weeks before study drug administration
  • History or active interstitial lung disease or pulmonary fibrosis
  • Other protocol-defined inclusion/exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 48 locations

1

Community Cancer Institute

Clovis, California, United States, 93611

Actively Recruiting

2

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

3

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

4

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

5

John Theurer Cancer Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

6

Local Institution - 0006

New York, New York, United States, 10032

Completed

7

Local Institution - 0002

New York, New York, United States, 10065

Completed

8

Providence Cancer Center Oncology and Hematology Care- Eastside

Portland, Oregon, United States, 97213

Actively Recruiting

9

Local Institution - 0063

Nashville, Tennessee, United States, 37067

Not Yet Recruiting

10

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

11

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

12

Blacktown Hospital

Blacktown, New South Wales, Australia, 2148

Actively Recruiting

13

Liverpool Hospital

Liverpool, New South Wales, Australia, 2170

Actively Recruiting

14

Princess Alexandra Hospital

Brisbane, Queensland, Australia, 4102

Actively Recruiting

15

Cabrini Hospital - Malvern

Malvern, Victoria, Australia, 3144

Actively Recruiting

16

St Vincent's Hospital

Melbourne, Victoria, Australia, 3065

Actively Recruiting

17

One Clinical Research

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

18

Cross Cancer Institute

Edmonton, Alberta, Canada, T6X 1E8

Actively Recruiting

19

BC Cancer Vancouver

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

20

Hamilton Health Sciences-Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V5C2

Actively Recruiting

21

Local Institution - 0009

Toronto, Ontario, Canada, M5G 2M9

Completed

22

Centre Hospitalier de luniversite de Montreal

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

23

The Ottawa Hospital Cancer Centre

Ottawa, Canada, K1H 8L6

Actively Recruiting

24

Local Institution - 0067

Beijing, Beijing Municipality, China, 100142

Not Yet Recruiting

25

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

26

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

Dresden, Germany, 01307

Actively Recruiting

27

Universitaetsklinikum Essen

Essen, Germany, 45147

Actively Recruiting

28

Universitatsklinikum Frankfurt

Frankfurt, Germany, 60590

Actively Recruiting

29

Universitaetsklinikum Wuerzburg

Würzburg, Germany, 97078

Actively Recruiting

30

Rabin Medical Center

Petah Tikva, Central District, Israel, 4941492

Actively Recruiting

31

Local Institution - 0035

Ramat Gan, Central District, Israel, 5265601

Withdrawn

32

Sheba Medical Center

Ramat Gan, Central District, Israel, 5265601

Actively Recruiting

33

Rambam Health Care Campus

Haifa, Northern District, Israel, 3109601

Actively Recruiting

34

Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel, 6423906

Actively Recruiting

35

Humanitas

Rozzano, Milano, Italy, 20089

Actively Recruiting

36

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

Candiolo, Torino, Italy, 10060

Actively Recruiting

37

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

Milan, Italy, 20133

Actively Recruiting

38

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Italy, 80131

Actively Recruiting

39

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

Roma, Italy, 00168

Actively Recruiting

40

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

Siena, Italy, 53100

Actively Recruiting

41

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Actively Recruiting

42

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain, 29010

Actively Recruiting

43

Institut Catalan d Oncologia (ICO) - Badalona

Badalona, Barcelona [Barcelona], Spain, 08916

Actively Recruiting

44

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain, 08035

Actively Recruiting

45

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain, 28041

Actively Recruiting

46

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

Madrid, Spain, 28040

Actively Recruiting

47

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

Madrid, Spain, 28050

Actively Recruiting

48

Clinica Universidad de Navarra-oNCOLOGY

Pamplona, Spain, 31008

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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