Study on IV Telisotuzumab Adizutecan and Pembrolizumab for First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT07744126
This clinical trial is testing a new combination of drugs, telisotuzumab adizutecan and pembrolizumab, to see if they can effectively treat adults with recurrent or metastatic head and neck cancer. The study aims to find the best dose and monitor any side effects.
Patient Parameters
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Program Overview
Head and neck squamous cell carcinoma (HNSCC) is a common type of cancer affecting many people worldwide. This study is exploring a new treatment option for adults with HNSCC that has come back or spread to other parts of the body. The trial will test the combination of two drugs, telisotuzumab adizutecan and pembrolizumab, to see how well they work together as a first treatment option. Participants will be divided into three groups, each receiving different treatments, including the new drug combination or standard chemotherapy with pembrolizumab. The study will last about 67 weeks, and around 180 participants from various locations will take part. Participants will visit the hospital or clinic every three weeks for check-ups, blood tests, and to monitor any side effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma that cannot be cured with local treatments.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Tumors must show c-Met protein in at least 25% of the cancer cells.
- Must have measurable cancer according to standard criteria.
- Have not received any previous systemic treatment for recurrent or metastatic head and neck cancer.
Exclusion Criteria
- Have a history of lung diseases like interstitial lung disease or pneumonitis that needed steroid treatment, or show signs of these conditions on a chest CT scan.
- Have any major, life-threatening health conditions.
- Must have a life expectancy of at least 3 months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City Of Hope Comprehensive Cancer Center /ID# 281939 | 91030 | Duarte | California |
| City of Hope - Atlanta /ID# 285268 | 30265 | Newnan | Georgia |
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