Clinical trial NCT04112498: A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab
Official title: A Phase 1, Multi-Tumor, Bioavailability Study of Relatlimab in Combination With Nivolumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors
* Melanoma
* Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)
* Gastric adenocarcinoma (includes gastro-esophageal junction)
* Hepatocellular carcinoma (HCC)
* Squamous cell carcinoma of the head and neck (SCCHN)
* Renal cell carcinoma (RCC)
* Bladder cancer
* Participants must have received available standard therapies
* Women and men must agree to follow instructions for method of contraception
* Measureable disease as per RECIST version 1.1 criteria
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Participants must not have active brain metastases or leptomeningeal metastases
* Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites
* History of allergy or hypersensitivity to study drug components
* Participants with serious or uncontrolled cardiovascular disease
* Excluding patients with serious or uncontrolled medical disorders
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
* Participants with an active, known, or suspected autoimmune disease
* Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Other protocol defined inclusion/exclusion Criteria could apply

Primary outcomes:
measure: maximum observed serum concentration (Cmax)
timeFrame: approximately 60 days
measure: time of maximum observed serum concentration (Tmax)
timeFrame: approximately 60 days
measure: area under the time-concentration curve over the dosing interval AUC (TAU)
timeFrame: approximately 60 days
measure: Observed concentration at the end of the dosing interval (Ctau)
timeFrame: approximately 60 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: approximately 2 years
measure: Incidence of Adverse Events (AEs)
timeFrame: approximately 2 years
measure: Incidence of Adverse Events leading to discontinuation
timeFrame: approximately 2 years
measure: Number of deaths
timeFrame: approximately 2 years
measure: Number of laboratory abnormalities
timeFrame: approximately 2 years
Secondary outcomes:
measure: Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction
timeFrame: approximately 2 years
measure: Number of events within the hypersensitivity/infusion reaction select AE category
timeFrame: approximately 2 years
measure: Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable)
timeFrame: approximately 2 years
measure: Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable)
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
Study officials:
References: