Study on Monalizumab and Cetuximab vs. Placebo and Cetuximab for Recurrent or Metastatic Head and Neck Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04590963
This clinical trial is comparing the effectiveness and safety of a new treatment combination, monalizumab and cetuximab, against a placebo and cetuximab in patients with head and neck cancer that has returned or spread.
Patient Parameters
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Program Overview
This study is testing whether a combination of two drugs, monalizumab and cetuximab, is more effective and safe compared to a placebo and cetuximab in treating patients with head and neck cancer that has come back or spread to other parts of the body. The trial involves multiple centers around the world and is conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo.
Description
Participants in this study have head and neck cancer that has returned or spread after previous treatments, including immune therapy and chemotherapy. They will be randomly assigned to receive either the new treatment combination of monalizumab and cetuximab or a placebo with cetuximab. The study will monitor the effectiveness and safety of these treatments over time. Participants will continue with the treatment until their cancer progresses, they experience unacceptable side effects, they choose to stop, or another reason for stopping arises. After the treatment phase, all participants will be followed to track their survival.
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older.
- Have recurrent or metastatic squamous cell carcinoma of the head and neck, including areas like the oral cavity, oropharynx, hypopharynx, or larynx, that has worsened after previous cancer treatments and cannot be cured with surgery or radiation.
- Previously treated with a PD-L1 inhibitor.
- Cancer did not respond to platinum-based chemotherapy.
- Have had 1 or 2 previous treatments for recurrent or metastatic head and neck cancer.
- Have cancer that can be measured by scans or tests.
- Able to provide a recent tumor sample for testing.
- In good general health, able to carry out normal activities or light work.
Exclusion Criteria
- Have head and neck cancer in areas not specified in the inclusion criteria or have a type of head and neck cancer that is not squamous cell carcinoma.
- Previously treated with cetuximab, unless it was given with radiation and there was no cancer progression for at least 6 months after the last dose.
- Have active or previously diagnosed autoimmune or inflammatory diseases, such as inflammatory bowel disease.
- Currently receiving any other cancer treatments, except for hormone therapy for non-cancer conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 60612 | Chicago | Illinois |
| Research Site | 66205 | Westwood | Kansas |
| Research Site | 02215 | Boston | Massachusetts |
| Research Site | 48109 | Ann Arbor | Michigan |
| Research Site | 55905 | Rochester | Minnesota |
| Research Site | 63110 | St Louis | Missouri |
| Research Site | 89169 | Las Vegas | Nevada |
| Research Site | 10029 | New York | New York |
| Research Site | 28204 | Charlotte | North Carolina |
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