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 (50)

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

Local Institution - 0062

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 Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

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

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

CONTACT