BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Categories (click each to see list of all clinical trials associated with that category): Head & Neck (ONC), Melanoma (ONC)
Current Status: Open
Phase: II
Principal Investigator: Marr, Alissa
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/study/NCT05136196?term=NCT05136196&draw=2&rank=1#eligibility
Summary
1.1 Primary Objective(s)
a. To evaluate the feasibility of molecular characterization based on TMB for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study.
b. To evaluate the feasibility of molecular characterization based on TMB and GEP (for TIS) for stratification in the overall study (Stage I and Stage II).
c. To evaluate the efficacy by overall response rate (ORR - defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups.
1.2 Secondary Objective(s)
a. To assess the difference in ORR in each disease cohort between tumor marker subgroups separately for each disease cohort.
b. To assess safety and tolerability of this treatment in these populations.
c. To estimate disease control rate (DCR) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers.
d. To estimate progression-free survival (PFS) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers.
e. To estimate overall survival (OS) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers.
f. To assess the proportion of patients with assay failure, and the time from the date of tissue collection to molecular group determination at the end of Stage I.
g. To assess turnaround time for TIS for at least 30 patients in Stage I to ensure that at least 75% have a turnaround time of < 21 days. If TIS is not ready for real-time testing when 30 slots remain for Stage I, accrual will be paused until assay validation is complete.
1.3 Additional Objective(s)
a. To identify candidate biomarkers predictive of response and toxicity to the cabozantinib and nivolumab combination.
1.4 Banking Objectives
a. To bank specimens for future correlative studies.