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

Phase 2RecruitingNCT04895709

Bristol-Myers Squibb949 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

949

Conditions

Cervical Cancer Gastric/Gastroesophageal Junction Adenocarcinoma Microsatellite Stable Colorectal Cancer Non-Small-Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck

Interventions

BMS-986340DRUG

Specified dose on specified days

BMS-936558-01DRUG

Specified dose on specified days

DocetaxelDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (48)

Community Cancer Institute

Clovis, California, United States

RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

RECRUITING

University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time frame: Up to 120 weeks

Incidence of serious adverse events (SAEs)

Time frame: Up to 120 weeks

Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

Time frame: Up to 120 weeks

Incidence of AEs leading to discontinuation

Time frame: Up to 120 weeks

Incidence of AEs leading to death

Time frame: Up to 120 weeks

Secondary Outcomes

Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)

Time frame: Up to 120 weeks

PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)

Time frame: 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

PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)

Time frame: Up to 120 weeks

PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)

Time frame: Up to 120 weeks

PK parameters of BMS-986340 administered in combination with docetaxel: Cmax

Time frame: 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

PK parameters of BMS-986340 administered in combination with docetaxel: Tmax

Time frame: 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

PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)

Time frame: 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

PK parameters of BMS-986340 administered in combination with docetaxel: Ctau

Time frame: Up to 120 weeks

Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy

Time frame: Up to 120 weeks

Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab

Time frame: Up to 120 weeks

Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel

Time frame: 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

Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

Time frame: 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

Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

Time frame: At 6 months, 12 months

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

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

CONTACT