Clinical Trial Summary (S2101)
Testing Biomarkers and Immunotherapy Drugs for People with Advanced Melanoma or Squamous-Cell Head and Neck Cancer
What is the purpose of this clinical trial?
The purpose of this study is to find out if specific biomarkers can reveal how cancer responds to a combination of 2 immunotherapy drugs. |
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- A biomarker is any molecule in your body that can be measured. Doctors look at biomarkers to learn what is happening in your body. Knowing about certain biomarkers of your tumor can give your doctor more information about what is causing the cancer to grow and how to treat it.
- Immunotherapy is a type of treatment that helps the immune system fight cancer.
In this trial, researchers will test immunotherapy treatment and measure biomarkers in people who have advanced melanoma or squamous-cell head and neck cancer.
This trial is set up to find out:
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If treatment with 2 immunotherapy drugs
can help shrink or control advanced melanoma and squamous-cell head and neck cancer -
How people with different biomarkers respond to treatment with the study drugs
Why is this trial important?
The Food and Drug Administration (FDA) has approved the study drugs, cabozantinib and nivolumab, to treat other cancers. This study will help find out if combining the drugs can benefit people with advanced melanoma or head and neck cancer. Using the drugs together for these cancers has not yet been approved by the FDA.
The study will also help researchers learn if this combination of drugs is more likely to work for people with certain biomarkers. This could help doctors choose the best treatments for their patients and help more patients benefit from immunotherapy.
Who can be in this trial?
This trial is for adults, age 18 or older, with advanced melanoma or squamous-cell head and neck cancer.
This trial may be for people who:
Have cancer that has gotten worse or spread to other parts of the body after immune checkpoint inhibitor therapy
This trial is not for people who:
- Have a primary tumor of the nasopharynx (the top part of the throat, behind the nose)
- Have an active infection of HIV, hepatitis B, or hepatitis C
- Have heart problems or poor organ function that may make it unsafe to get treatment in this study
- Are pregnant
Talk with your doctor to learn more about who can join this study.
What can I expect during the trial?
This trial has 2 parts. If you join the trial, you will be in either Part 1 or Part 2, but not both.
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How long will I be in the trial?
If you get the study treatment, you will be in the study for 3 years. Your study doctor will closely watch you for side effects and watch how your cancer responds to the treatment.
If the treatment keeps helping you, you may continue it for up to 2 years. You may choose to stop treatment at any time for any reason.
After treatment, you will have follow-up visits with the study team until you have been in the study for 3 years total.
Are there costs? Will I get paid?
The study drugs, cabozantinib and nivolumab, are provided free to you. The study also covers the costs of the biopsy for biomarker testing.
You will not be paid for joining the study. Check with your health care provider and insurance provider to find out what costs will and won’t be covered in this study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search using the national clinical trial number: 05136196
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S2101
NCT Number
05136196
Full Trial Title
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
Trial Sponsors
SWOG Cancer Research Network
Publication Date