Description:
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
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CA224-087
- NCT ID:
NCT04112498
Conditions
Interventions
Drug | Synonyms | Arms |
---|
relatlimab | | nivolumab + relatlimab + rHuPH20 |
nivolumab | Opdivo | nivolumab + relatlimab + rHuPH20 |
rHuPH20 | Enhanze | nivolumab + relatlimab + rHuPH20 |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
nivolumab + relatlimab + rHuPH20 | Experimental | | - relatlimab
- nivolumab
- rHuPH20
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | maximum observed serum concentration (Cmax) |
Time Frame: | approximately 60 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Number of events within the hypersensitivity/infusion reaction select AE category |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable) |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable) |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 5, 2020