OncoMatch/Clinical Trials/NCT05136196
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
Is NCT05136196 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Cabozantinib S-malate for clinical stage iii cutaneous melanoma ajcc v8.
Treatment: Cabozantinib S-malate · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Allowed: PD-L1 (CD274) any tested
documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy
Allowed: PD-L1 (CD274) any tested
recurrence during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment
Allowed: TP53 p16-positive
For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration
Disease stage
Required: Stage III, IV
Performance status
ZUBROD 0–1
Prior therapy
Must have received: anti-PD-1 therapy
documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable
Cannot have received: anti-VEGF therapy
must not have received prior treatment with anti-VEGF therapies for any reason
Cannot have received: radiation therapy
Exception: no more than one prior primary radiotherapy regimen to the mucosal surfaces of the head and neck; additional palliative regimens permitted if not overlapping fields (except CNS radiation); minimum intervals required between end of radiotherapy and registration
must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck
Lab requirements
Blood counts
Leukocytes ≥ 3,000/uL; Absolute neutrophil count ≥ 1,500/uL; Platelets ≥ 100,000/uL
Kidney function
Measured (OR calculated) creatinine clearance ≥ 30 mL/min using Cockcroft-Gault Formula
Liver function
Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN for participants with Gilbert's disease; AST ≤ 3 x ULN; ALT ≤ 3 x ULN
Cardiac function
Adequate cardiac function; if cardiac disease history or symptoms, must be NYHA class 2B or better
Leukocytes ≥ 3,000/uL; Absolute neutrophil count ≥ 1,500/uL; Platelets ≥ 100,000/uL; Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN for participants with Gilbert's disease; AST ≤ 3 x ULN; ALT ≤ 3 x ULN; Measured (OR calculated) creatinine clearance ≥ 30 mL/min; adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- Tower Cancer Research Foundation · Beverly Hills, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- The Angeles Clinic and Research Institute - West Los Angeles Office · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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