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

March 29, 2024 updated by: Bristol-Myers Squibb

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

665

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital
        • Contact:
          • Adnan Nagrial, Site 0057
          • Phone Number: 02 8890 3343
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Abhijit Pal, Site 0058
          • Phone Number: 61287389744
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Aaron Hansen, Site 0054
          • Phone Number: 61 7 3176 5564
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Local Institution - 0053
        • Contact:
          • Site 0053
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Melissa Moore, Site 0055
          • Phone Number: 61392313155
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
  • Canada
      • Ottawa, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital Cancer Centre
        • Contact:
          • John Hilton, Site 0016
          • Phone Number: (613)737-7700
    • Alberta
      • Edmonton, Alberta, Canada, T6X 1E8
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Quincy Chu, Site 0027
          • Phone Number: 7804328248
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver
        • Contact:
          • Anna Tinker, Site 0030
          • Phone Number: 604-877-6000
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre
        • Contact:
          • Sebastien Hotte, Site 0029
          • Phone Number: 9053170886
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de luniversite de Montreal
        • Contact:
          • Rahima Jamal, Site 0015
          • Phone Number: 51489080008444
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
        • Contact:
          • Martin Wermke, Site 0010
          • Phone Number: +493514587566
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
        • Contact:
          • Stefan Kasper-Virchow, Site 0018
          • Phone Number: 0049201 7233449
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitatsklinikum Frankfurt
        • Contact:
          • Martin Sebastian, Site 0020
          • Phone Number: +496963016217
      • Ulm, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Contact:
          • Simon Laban, Site 0044
          • Phone Number: 4973150059548
      • Wuerzburg, Germany, 97078
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
          • Cyrus Sayehli, Site 0019
          • Phone Number: 4993120140964
  • Israel
    • HaMerkaz
      • Petah Tikva, HaMerkaz, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Contact:
          • Salomon Stemmer, Site 0036
          • Phone Number: 97239378076
      • Ramat Gan, HaMerkaz, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Tamar Beller, Site 0038
          • Phone Number: 97235307039
      • Ramat Gan, HaMerkaz, Israel, 5265601
        • Withdrawn
        • Local Institution - 0035
    • HaTsafon
      • Haifa, HaTsafon, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Ruth Perets, Site 0039
          • Phone Number: +972-47776700
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Ravit Geva, Site 0037
          • Phone Number: 97236973082
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
        • Contact:
          • Filippo De Braud, Site 0024
          • Phone Number: 390223903066
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
        • Contact:
          • Paolo Ascierto, Site 0034
          • Phone Number: 390815903431
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
        • Contact:
          • Gennaro Daniele, Site 0040
          • Phone Number: +390630153446
      • Siena, Italy, 53100
        • Recruiting
        • ospedale le scotte-U.O.C. Immunoterapia Oncologica
        • Contact:
          • Michele Maio, Site 0025
          • Phone Number: 390577586335
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas
        • Contact:
          • Matteo Simonelli, Site 0023
          • Phone Number: +390282244559
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Istituto di Candiolo
        • Contact:
          • Vanesa Gregorc, Site 0033
          • Phone Number: 390119933250
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Not yet recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
  • Spain
      • Madrid, Spain, 28050
        • Recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD
        • Contact:
          • Victor Moreno Garcia, Site 0013
          • Phone Number: 615387743
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra-oNCOLOGY
        • Contact:
          • Ignacio Melero Bermejo, Site 0012
          • Phone Number: 34653574014
    • Andalucía
      • Málaga, Andalucía, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Javier Garcia Corbacho, Site 0048
          • Phone Number: 951032250
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona
        • Contact:
          • Cinta Hierro Carbo, Site 0014
          • Phone Number: 34934978925
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Elena Garralda Cabanas, Site 0049
          • Phone Number: 349327460004910
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28041
        • Recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
  • United States
    • California
      • Clovis, California, United States, 93611
        • Recruiting
        • Community Cancer Institute
        • Contact:
          • Uzair Chaudhary, Site 0032
          • Phone Number: 559-387-1600
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Contact:
          • Anthony El-Khoueiry, Site 0041
          • Phone Number: 323-865-3967
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Contact:
          • Carlos Becerra, Site 0050
          • Phone Number: 949-764-8222
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Contact:
          • Yousef Zakharia, Site 0062
          • Phone Number: 319-384-8076
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center
        • Contact:
          • Martin Gutierrez, Site 0007
          • Phone Number: 551-996-5863
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Ryan Moy, Site 0006
          • Phone Number: 714-726-7966
      • New York, New York, United States, 10065
        • Completed
        • Memorial Sloan Kettering Nassau
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Center Oncology and Hematology Care- Eastside
        • Contact:
          • Rom Leidner, Site 0001
          • Phone Number: 503-215-5696
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Jordan Berlin, Site 0052
          • Phone Number: 615-343-4967
      • Nashville, Tennessee, United States, 37067
        • Not yet recruiting
        • Vanderbilt Health One Hundred Oaks
        • Contact:
          • Jordan Berlin, Site 0063
          • Phone Number: 615-343-4967
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist Hospital
        • Contact:
          • Maen Abdelrahim, Site 0061
          • Phone Number: 346-241-5495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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, 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: BMS-986340 Dose Escalation
Drug: BMS-986340
Specified dose on specified days
Experimental: Part 2A: BMS-986340 Dose Expansion
Drug: BMS-986340
Specified dose on specified days
Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation
Drug: BMS-986340
Specified dose on specified days
Drug: BMS-936558-01
Specified dose on specified days
Other Names:
  • Nivolumab
Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion
Drug: BMS-986340
Specified dose on specified days
Drug: BMS-936558-01
Specified dose on specified days
Other Names:
  • Nivolumab
Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation
Drug: Docetaxel
Specified dose on specified days
Drug: BMS-986340
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of AEs leading to discontinuation
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of AEs leading to death
Time Frame: Up to 120 weeks
Up to 120 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
Time Frame: Up to 120 weeks
Up to 120 weeks
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame: At 6 months, 12 months
At 6 months, 12 months
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame: At 6 months, 12 months
At 6 months, 12 months
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame: At 6 months, 12 months
At 6 months, 12 months
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame: At 6 months, 12 months
At 6 months, 12 months
PK parameters of BMS-986340 administered in combination with docetaxel: Cmax
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: Tmax
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)
Time Frame: Up to 120 weeks
Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: Ctau
Time Frame: Up to 120 weeks
Up to 120 weeks
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel
Time Frame: Up to 120 weeks
Up to 120 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2021

Primary Completion (Estimated)

April 10, 2025

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA052-002
  • 2021-001188-26 (EudraCT Number)
  • U1111-1265-4508 (Registry Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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