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Trial purpose
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
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NATIONAL TRIAL REFERENCE NUMBER | NCT04949256 |
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Conditions | Metastatic Esophageal Squamous Cell Carcinoma |
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Age Range | 18+ |
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Sex | All |
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Current trial phase | 1 |
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Trial start and end dates | [07-28-2021] [12-29-2025] |
About the trial
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Metastatic Esophageal Squamous Cell Carcinoma
All patients who enroll in the trial will receive medication while on the study.
50% will receive pembrolizumab plus levatinib plus chemotherapy followed by pembrolizumab plus levatinib
50% will receive pembrolizumab plus chemotherapy
*A computer will decide which group you are put in. You have an equal chance of being in either group. You, your trial doctor, and the trial staff will know what you are getting.
Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial locations (0)
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.