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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: N/A
  • NCT ID: NCT04895709
  • Sponsor: Bristol-Myers Squibb

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
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: BMS Study Connect Contact Center www.BMSStudyConnect.com, First line of the email MUST contain NCT # and Site #.

Phone: 855-907-3286

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact