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Brief Title: BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: CA052-002
  • Secondary ID: 2021-001188-26, U1111-1265-4508
  • NTC ID: NCT04895709
  • Sponsor: Bristol-Myers Squibb
BMS Clinical Trial Information, BMS Clinical Trial Patient Recruiting, FDA Safety Alerts and Recalls, Investigator Inquiry Form

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.

  • Overall Status
    Recruiting
  • Start Date
    May 27, 2021
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events (AEs)

Primary Outcome 1 - Timeframe: Up to 120 weeks

Primary Outcome 2 - Measure: Incidence of serious adverse events (SAEs)

Primary Outcome 2 - Timeframe: Up to 120 weeks

Primary Outcome 3 - Measure: Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

Primary Outcome 3 - Timeframe: Up to 120 weeks

Primary Outcome 4 - Measure: Incidence of AEs leading to discontinuation

Primary Outcome 4 - Timeframe: Up to 120 weeks

Primary Outcome 5 - Measure: Incidence of AEs leading to death

Primary Outcome 5 - Timeframe: Up to 120 weeks

CONDITION

  • Cervical Cancer
  • Gastric/Gastroesophageal Junction Adenocarcinoma
  • Microsatellite Stable Colorectal 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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: 855-907-3286

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: John Theurer Cancer Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: Contact
Martin Gutierrez, Site 0007
551-996-5863
Facility: Columbia University Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical Protoco
New York, New York 10032
United States
Status: Recruiting Contact: Contact
Richard Carvajal, Site 0006
646-371-6330
Facility: Memorial Sloan Kettering Nassau
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Margaret Callahan, Site 0002
186-049-0095
Facility: Providence Cancer Center Oncology and Hematology Care- Eastside
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Rom Leidner, Site 0001
503-215-5696
Facility: Local Institution - 0009
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: Contact
Site 0009

Facility: Local Institution - 0015
Montreal, Quebec H2X 0A9
Canada
Status: Recruiting Contact: Contact
Site 0015

Facility: Local Institution - 0016
Ottawa, HaMerkaz K1H 8L6
Canada
Status: Recruiting Contact: Contact
Site 0016

Facility: Local Institution - 0010
Dresden, HaMerkaz 01307
Germany
Status: Recruiting Contact: Contact
Site 0010

Facility: Local Institution - 0019
Wuerzburg, Torino 97078
Germany
Status: Recruiting Contact: Contact
Site 0019

Facility: Humanitas
Rozzano, 20089
Italy
Status: Recruiting Contact: Contact
Matteo Simonelli, Site 0023

Facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan, 20133
Italy
Status: Recruiting Contact: Contact
Filippo De Braud, Site 0024

Facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, 53100
Italy
Status: Recruiting Contact: Contact
Michele Maio, Site 0025

Facility: Local Institution - 0014
Badalona, 08916
Spain
Status: Recruiting Contact: Contact
Site 0014

Facility: Local Institution - 0013
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Site 0013

Facility: Local Institution - 0011
Madrid, 28050
Spain
Status: Recruiting Contact: Contact
Site 0011

Facility: Local Institution - 0012
Pamplona, 31008
Spain
Status: Recruiting Contact: Contact
Site 0012