Active, Not Recruiting

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).

View full trial information on Clinicaltrials.gov
NATIONAL TRIAL REFERENCE NUMBER NCT04949256
Conditions Metastatic Esophageal Squamous Cell Carcinoma
Age Range 18+
Sex All
Current trial phase 1
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

View full trial eligibility

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.

What can you do next?

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

NATIONAL TRIAL REFERENCE NUMBER

NCT04949256

When you talk with your doctor or clinical trial team member, please have the national trial reference number available.

This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.