Cancer
Conditions
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
Interventions
DRUGrelatlimab
Specified dose on Specified days
DRUGnivolumab
Specified dose on Specified days
DRUGrHuPH20
Specified dose on Specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of laboratory abnormalities | approximately 2 years |
| Incidence of Serious Adverse Events (SAEs) | approximately 2 years |
| Incidence of Adverse Events (AEs) | approximately 2 years |
| Incidence of Adverse Events leading to discontinuation | approximately 2 years |
| Number of deaths | approximately 2 years |
| maximum observed serum concentration (Cmax) | approximately 60 days |
| time of maximum observed serum concentration (Tmax) | approximately 60 days |
| area under the time-concentration curve over the dosing interval AUC (TAU) | approximately 60 days |
| Observed concentration at the end of the dosing interval (Ctau) | approximately 60 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of events within the hypersensitivity/infusion reaction select AE category | approximately 2 years |
| Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable) | approximately 2 years |
| Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable) | approximately 2 years |
| Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction | approximately 2 years |
Countries
United States
Outcome results
None listed