Study of Lenvatinib, Pembrolizumab, and Chemotherapy Combination for Patients with Advanced Esophageal Cancer Previously Treated with PD-1/PD-L1 Therapy

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What is this study about?

This clinical trial is focused on studying treatments for advanced esophageal cancer, specifically a type called esophageal squamous cell carcinoma. The study will explore the effects of different combination therapies, which may include investigational drugs and/or chemotherapy. Some of the medications being tested include Lenvatinib (also known by the code name MK-7902), MK-4830, MK-2870 (also known as Sacituzumab Tirumotecan), and Keytruda (known scientifically as Pembrolizumab). These treatments will be compared to a placebo to understand their effectiveness and safety.

The purpose of this study is to evaluate the safety and tolerability of these combination treatments and to estimate how well they work in treating the cancer. Participants in the study will receive these treatments and be monitored for any side effects or improvements in their condition. The study will be conducted in phases, starting with a safety lead-in phase to ensure the treatments are safe for participants. Following this, the study will assess how well the treatments work in controlling the cancer.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the progress of their cancer. The study aims to provide valuable information on the potential benefits and risks of these new treatment combinations for people with advanced esophageal cancer. The results will help determine if these treatments can be used more widely in the future to improve outcomes for patients with this type of cancer.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures. The participant will provide consent to participate in the study.

2 safety lead-in phase

The safety lead-in phase aims to evaluate the safety and tolerability of the combination treatments. Participants will receive investigational agents, possibly with pembrolizumab and/or chemotherapy.

During this phase, participants will be monitored for any dose-limiting toxicities and adverse events. The number of participants experiencing these will be recorded.

3 treatment administration

Participants will receive various medications, including lenvatinib (oral capsules), famotidine (oral), paclitaxel (intravenous), MK-4830 (intravenous), sacituzumab tirumotecan (intravenous), irinotecan hydrochloride (intravenous), and pembrolizumab (intravenous).

The specific dosage, frequency, and duration of administration will be determined based on the participant’s response and the study protocol.

4 efficacy phase

The efficacy phase will assess the objective response rate, progression-free survival, duration of response, and overall survival.

Participants will continue to receive treatment and will be monitored for any adverse events. The number of participants experiencing adverse events and those who discontinue treatment due to these events will be recorded.

5 end of study

The study is estimated to end by September 20, 2028. Participants will undergo final assessments to evaluate the outcomes of the treatment.

Who Can Join the Study?

The patient must have a confirmed diagnosis of advanced esophageal squamous cell carcinoma. This means the cancer is in the esophagus and is either spread to other parts of the body or cannot be removed by surgery.
The patient must have shown disease progression, meaning the cancer has gotten worse, after receiving one prior standard treatment that included a platinum agent (a type of chemotherapy) and a therapy targeting PD1/PD-L1 (proteins involved in the immune system).
The patient must have a tumor sample available for analysis. This sample can be newly obtained or from previous tests.
The patient must have blood pressure that is well-controlled, whether or not they are taking medication for it.
If the patient had side effects from previous cancer treatments, these side effects must have improved to a mild level or returned to what they were before treatment. If the side effects are related to hormones and are being treated with hormone replacement, or if the patient has mild nerve damage (neuropathy), they can still participate.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients with other types of cancer besides advanced esophageal squamous cell carcinoma cannot participate.
Patients who have not recovered from previous cancer treatments may be excluded.
Patients with serious heart problems might not be eligible.
Patients with uncontrolled infections may be excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar treatments may be excluded.
Patients with certain autoimmune diseases, where the immune system attacks the body, might not be eligible.
Patients who have received another investigational drug within a certain time frame may be excluded.
Patients with certain brain conditions or who have had a stroke recently might not be eligible.
Patients with severe liver or kidney problems may be excluded.
Patients who are unable to follow the study procedures or attend appointments might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Inskqzje Rvszqlywj Prz Lw Snycpl Dsb Trcoqg Dbzy Ardnyxf Ifcf Sezmsw	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	18.02.2024
Italy	Recruiting	18.02.2024
Norway	Recruiting	18.02.2024

Trial locations

Investigated drugs:

Pembrolizumab: This medication is used to help the immune system detect and fight cancer cells. It is often used in treating various types of cancer, including esophageal cancer. In this trial, it is being tested in combination with other investigational agents and/or chemotherapy to see if it can improve treatment outcomes for patients who have already been treated with PD-1/PD-L1 therapies.

Chemotherapy: This is a type of cancer treatment that uses drugs to destroy cancer cells. It works by stopping or slowing the growth of cancer cells, which grow and divide quickly. In this study, chemotherapy is being used in combination with other investigational agents and/or pembrolizumab to evaluate its effectiveness in treating advanced esophageal cancer.

Advanced esophageal squamous cell carcinoma – This is a type of cancer that forms in the cells lining the esophagus, which is the tube that carries food from the throat to the stomach. It is characterized by the abnormal growth of squamous cells, which are flat cells that make up the surface of the esophagus. As the disease progresses, the cancer can invade deeper layers of the esophagus and spread to nearby tissues or other parts of the body. Symptoms may include difficulty swallowing, weight loss, and chest pain. The progression of the disease can lead to a narrowing of the esophagus, making it difficult for food and liquids to pass through. This type of cancer is often diagnosed at an advanced stage due to the subtlety of early symptoms.

Trial ID:

2023-505189-26-00

Protocol code:

MK-3475-06B

NCT ID:

NCT05319730

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Lenvatinib, Pembrolizumab, and Chemotherapy Combination for Patients with Advanced Esophageal Cancer Previously Treated with PD-1/PD-L1 Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?