Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
M.D. Anderson Cancer Center
Summary
To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.
Description
Primary Objectives: • To assess the intracranial objective response rate (iORR), defined as intracranial CR + PR per modified RECIST 1.1 criteria, of nivolumab + relatlimab (nivo+rela) in subjects with MBM and treatment naïve to anti-PD-1 agents in the metastatic setting. Secondary Objectives: * To determine the safety of the combination of nivo+rela * To assess the clinical benefit rate (CBR), defined as CR + PR + SD \>6 months, of the combination * To determine overall response rates (intracranial + extracranial), DoR, PFS, and using a modified version of iRANO and compared to modified RE…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Life Expectancy \> 12 weeks. 3. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. • Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. 4. Histologically confirmed malignant melanoma with measurable metastases in the brain (≥ 0.5 cm). 5. A…
Interventions
- DrugBMS-986213 (Relatlimab-Nivolumab FDC)
Given by IV (vein)
- DrugNivolumab
Given by IV (vein)
- DrugRelatlimab
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas