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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

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

Treatments

Drug: BMS-986340
Drug: BMS-936558-01
Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04895709
2021-001188-26 (EudraCT Number)
U1111-1265-4508 (Registry Identifier)
CA052-002

Details and patient eligibility

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.

Enrollment

665 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

665 participants in 5 patient groups

Part 1A: BMS-986340 Dose Escalation
Experimental group
Treatment:
Drug: BMS-986340
Part 2A: BMS-986340 Dose Expansion
Experimental group
Treatment:
Drug: BMS-986340
Part 1B: BMS-986340 + Nivolumab Dose Escalation
Experimental group
Treatment:
Drug: BMS-936558-01
Drug: BMS-986340
Part 2B: BMS-986340 + Nivolumab Dose Expansion
Experimental group
Treatment:
Drug: BMS-936558-01
Drug: BMS-986340
Part 1C: BMS-986340 + Docetaxel Dose Escalation
Experimental group
Treatment:
Drug: Docetaxel
Drug: BMS-986340

Trial contacts and locations

47

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Central trial contact

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

Data sourced from clinicaltrials.gov

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