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 (NCT05136196)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (229 Sites)
Showing the first 25 of 229 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
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Rocky Mountain Regional VA Medical Center — Aurora, Colorado
- UCHealth Memorial Hospital Central — Colorado Springs, Colorado
- Memorial Hospital North — Colorado Springs, Colorado
- Poudre Valley Hospital — Fort Collins, Colorado
- Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado
- UCHealth Greeley Hospital — Greeley, Colorado
- Medical Center of the Rockies — Loveland, Colorado
- Helen F Graham Cancer Center — Newark, Delaware
- Medical Oncology Hematology Consultants PA — Newark, Delaware
- Mayo Clinic in Florida — Jacksonville, Florida
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii
- Queen's Cancer Cenrer - POB I — Honolulu, Hawaii
- Queen's Medical Center — Honolulu, Hawaii
- Queen's Cancer Center - Kuakini — Honolulu, Hawaii
- Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii
- Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho
📞 Contact the Study Coordinator
Phone: (855) 776-0015
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clinical Stage III Cutaneous Melanoma AJCC v8
- Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma — Houston, Texas
- A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma — Boston, Massachusetts
- Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors — Nashville, Tennessee
- Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors — Houston, Texas
- Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy — Houston, Texas
- A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma — Anchorage, Alaska
Explore by condition: All Clinical Stage III Cutaneous Melanoma AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.