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Study identifier: NCT05136196 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Clinical Stage III Cutaneous Melanoma AJCC v8 · Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage IV Cutaneous Melanoma AJCC v8  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 2
Planned participants150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (225)

Mayo Clinic Hospital in ArizonaPhoenix, Arizona, United StatesRecruiting
University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting
Tower Cancer Research FoundationBeverly Hills, California, United StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California, United StatesRecruiting
The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, California, United StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, California, United StatesRecruiting
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesRecruiting
Rocky Mountain Regional VA Medical CenterAurora, Colorado, United StatesActive Not Recruiting
UCHealth Memorial Hospital CentralColorado Springs, Colorado, United StatesRecruiting
Memorial Hospital NorthColorado Springs, Colorado, United StatesRecruiting
Poudre Valley HospitalFort Collins, Colorado, United StatesRecruiting
Cancer Care and Hematology-Fort CollinsFort Collins, Colorado, United StatesRecruiting

+ 213 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05136196