Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

Protocol No
SWOG-S2101
Staff Member
Callisia Clarke
Phase
II
Summary

The purpose of this study is to test the good and bad effects of the combination of drugs called cabozantinib and nivolumab. This combination of drugs could shrink the cancer, but it could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drugs will shrink or stabilize the cancer.

Both of these drugs have already been approved by the FDA to treat other cancers. The drug combination of cabozantinib and nivolumab was approved by the Food and Drug Administration (FDA) as first line treatment for advanced renal cell carcinoma (kidney cancer). Cabozantinib has also been approved by the FDA in primary liver cancer. Nivolumab has been approved by the FDA in ten separate cancers, including melanoma and head and neck cancer.
The size of the study will vary depending on how many participants are registered in each biomarker sub-group. There will be around 120-150 people taking part in this study treatment. This may mean that we may need to do biomarker testing on up to 220 participants to ensure that we have enough participants in each group.

Objective
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Participants with Advanced Melanoma or Squamous Cell Head and Neck Cancer
Study Sites
Froedtert Hospital
Status
OPEN TO ACCRUAL