Clinical trial NCT04349267: Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Official title: A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Keywords: NSCLC (Non-small cell lung cancer)
RCC (Renal cell carcinoma)
SCCHN (Squamous cell carcinoma of the head and neck)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 119 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 119 weeks
measure: Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria
timeFrame: Up to 119 weeks
measure: Incidence of adverse events (AEs) leading to discontinuation
timeFrame: Up to 119 weeks
measure: Number of deaths
timeFrame: Up to 119 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 12 months
measure: Duration of Response (DOR)
timeFrame: Up to 12 months
measure: Progression-Free Survival Rate (PFSR)
timeFrame: Up to 12 months
measure: Maximum observed serum concentration (Cmax) of BMS-986315
timeFrame: Up to 16 weeks
measure: Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab
timeFrame: Up to 16 weeks
measure: Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab
timeFrame: Up to 16 weeks
measure: Time of maximum observed serum concentration (Tmax) of BMS-986315
timeFrame: Up to 16 weeks
measure: Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab
timeFrame: Up to 16 weeks
measure: Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab
timeFrame: Up to 16 weeks
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315
timeFrame: Up to 16 weeks
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab
timeFrame: Up to 16 weeks
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab
timeFrame: Up to 16 weeks
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315
timeFrame: Up to 16 weeks
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab
timeFrame: Up to 16 weeks
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab
timeFrame: Up to 16 weeks
measure: Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315
timeFrame: Up to 16 weeks
measure: Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab
timeFrame: Up to 16 weeks
measure: Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab
timeFrame: Up to 16 weeks
measure: Trough observed serum concentrations (Ctrough) of BMS-986315
timeFrame: Up to 119 weeks
measure: Incidence of anti-drug antibodies to BMS-986315
timeFrame: Up to 119 weeks
measure: Incidence of anti-drug antibodies to BMS-986315 with nivolumab
timeFrame: Up to 119 weeks
measure: Incidence of anti-drug antibodies to BMS-986315 with cetuximab
timeFrame: Up to 119 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Local Institution - 0028
state: South Dakota
city: Germantown
country: United States
facility: Local Institution - 0001
state: Tennessee
city: Edmonton
country: Canada
facility: Local Institution - 0014
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0011
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0004
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0005
state: Quebec
city: Ottawa
country: Canada
facility: Local Institution - 0013
city: Mexico city
country: Mexico
facility: Local Institution
state: Distrito Federal
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: