Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb44 enrolled

Overview

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

BMS-986315BIOLOGICAL

Specified dose on specified days

nivolumabBIOLOGICAL

Specified dose on specified days

cetuximabBIOLOGICAL

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1 * Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor * Eastern cooperative oncology group performance status of 0 or 1 * Women of childbearing potential must agree to follow methods of contraception Exclusion Criteria: * Participants with active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Uncontrolled or significant cardiovascular disease * History of or with active interstitial lung disease or pulmonary fibrosis * Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study * History of allergy or hypersensitivity to study drug components Other protocol-defined inclusion/exclusion criteria apply

Locations (8)

Local Institution - 0028

Sioux Falls, South Dakota, United States

Local Institution - 0001

Germantown, Tennessee, United States

Local Institution - 0014

Edmonton, Alberta, Canada

Local Institution - 0011

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Number of Participants With Adverse Events and Deaths

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time frame: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)

Number of Participants With Dose Limiting Toxicities (DLTs)

A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.

Time frame: From first dose (Day 1) untill Day 28

Secondary Outcomes

Objective Response Rate (ORR)

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Data from ClinicalTrials.gov

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Duration of Response (DoR)

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)