A Randomized Phase II Trial of Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Oligo-Metastatic Clear Cell Renal Cell Carcinoma
University of Oklahoma
Summary
The purpose of this research is to test the safety of PD-1 inhibitor cemiplimab with or without LAG-3 inhibitor fianlimab, and see what effects (good and bad) of cemiplimab either alone or combined with fianlimab has on patients with oligometastatic clear cell renal cell carcinoma after completion of radiation therapy.
Description
All eligible patients will undergo standard of care SBRT to primary tumor (if present) and/or all metastatic tumor sites prior to randomization. During radiotherapy, patients will receive 1 to 5 fractions delivered over 1-2 weeks. Then patients will be randomized at 1:1 ratio to the two arms: * ARM A: Cemiplimab, 350 mg, IV, and Fianlimab 1600 mg, IV, q3w for 1 year, * ARM B: Cemiplimab 350 mg, IV, Q3W for 1 year. Immune check point inhibition will occur within 3 weeks (+/-1 week) of completion of SBRT Patients will undergo treatment with the study drug(s) every 3 weeks for a maximum of 17…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be \>= 18 years of age. * Patient must have a biopsy/pathologically (histologically or cytologically) proven diagnosis of clear cell renal cell carcinoma (ccRCC) prior to randomization. * Patient must have at least 1 and not more than 5 metastatic lesions measurable by RECIST v1.1, with imaging obtained within 45 days prior to randomization. * Patients with untreated brain metastasis measuring \<2cm in diameter (intracranial RANO-BM measurable disease required) and with minimal neurological symptoms. Patients with treated brain metastasis are eligible for th…
Interventions
- DrugCemiplimab 350 MG Intravenous Solution
Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary Veloc Immune® technology. By binding to PD-1, cemiplimab (Libtayo) has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
- DrugFianlimab 1600 MG Intravenous Solution
Fianlimab is a recombinant fully human monoclonal antibody (based on IgG4 isotype) targeting the immune checkpoint receptor LAG-3 on T cells and was invented using Regeneron's proprietary Veloc Immune® technology.
Location
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma