A Phase II Study of Nivolumab Immunotherapy in Combination with 177Lu-Girentuximab for Advanced Kidney Cancer


Full Title

STARLITE 2: A Phase 2 Open-label Study of Nivolumab Combined with Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Clear Cell Renal Cell Carcinoma


The purpose of this study is to assess the safety and effectiveness of combining nivolumab immunotherapy with the drug 177Lu-girentuximab in people with advanced clear cell renal cell cancer that has continued to grow despite prior treatment. 177Lu-girentuximab includes an antibody and a radioactive particle that gives off a small amount of radiation. The antibody targets a protein called CAIX on cancer cells and delivers radiation to kill those cells when it binds to CAIX. Nivolumab, a standard treatment for advanced kidney cancer, boosts the power of the immune system to find and kill cancer cells. Both medications are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic clear cell renal cell carcinoma that has continued to grow despite previous treatment that included immunotherapy.
  • Patients’ tumors must contain the CAIX protein. Testing for this protein will be done at Memorial Sloan Kettering using PET scanning.
  • At least 2 weeks must pass between the completion of prior treatment and receipt of the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Darren Feldman at 646-888-4740.




Phase II (phase 2)



ClinicalTrials.gov ID