NCT04895709

A Study of 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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 949 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	BMS-986340	Specified dose on specified days
DRUG	BMS-936558-01	Specified dose on specified days
DRUG	Docetaxel	Specified dose on specified days

Timeline

• Start date: 2021-05-27
• Primary completion: 2028-07-07
• Completion: 2028-07-07
• First posted: 2021-05-20
• Last updated: 2026-04-13

Locations

48 sites across 9 countries: United States, Australia, Canada, China, Germany, Israel, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study