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

Brief description of study

This is a pilot study to see whether biomarkers called Tumor Mutation Burden (TMB) and Gene Expression Profiling (GEP) can be used to study the response of combination of cabozantinib and nivolumab drugs in patients with advanced melanoma or head and neck cancer who have progressed after prior anti-PD1-based treatment. Tumor mutational burden (TMB) measures the number of genetic changes happening in a tumor's DNA. Gene Expression Profiling (GEP) biomarkers are patterns of gene activity used to study the tumor response to the treatment.

All participants will receive the same treatment- Nivolumab 480 mg in combination with Cabozantinib 40 mg. Cabozantinib is a multi-targeted receptor tyrosine kinase (RTK) inhibitor that works by blocking the action of several tyrosine kinases, a type of protein that plays a key role in cancer cell growth and survival. Nivolumab is an immunotherapy drug that works by stimulating the body's own immune system to fight cancer cells. All patients will be tested for TMB and GEP biomarkers and divided into four biological groups based on TMB and GEP scores (hi/hi, hi/lo, lo/hi, or lo/lo).

All patients will have special scans done to see how their cancer is changing in response to the treatment and how long it takes the cancer to come back. Patients will have blood samples taken for special testing of circulating tumor DNA (ctDNA) to check for TMB and other biomarkers. All patients will be closely monitored for potential side effects and safety concerns.


Clinical Study Identifier: s24-00367
ClinicalTrials.gov Identifier: NCT05136196
Principal Investigator: Ruth A White.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Maya Dimitrova, Zujun Li, Elka R Travis, Jeffrey S. Weber, Kenneth S Hu, Allison Most, Nila Theresa De La Rosa, Colin Hill, Elise M Zahriah, Danny Perlaza, Catherine M Concert, Marissa Rybstein, Mariam M Cheaib, Kathleen M Madden, Ann M Riccobene, Megan DiBenedetto, Rafael Winograd, Janice Mehnert, Maria Francis.


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