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PD-1/PD-L1 Inhibitor

Investigational Agents + Pembrolizumab for Esophageal Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC
Has adequately controlled blood pressure (BP) with or without antihypertensive medications
Must not have
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Clinically significant cardiovascular disease within 12 months from first dose of study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 189 weeks
Awards & highlights

Summary

This trial is testing the safety and effectiveness of new drugs, either alone or in combination with pembrolizumab and/or chemotherapy, for people with a specific type of esophageal cancer who have

Who is the study for?
This trial is for individuals with advanced esophageal cancer who have already tried treatments targeting PD-1/PD-L1 proteins. Participants should be ready for second-line therapy and meet other health criteria set by the study.
What is being tested?
The study tests various agents, like Sacituzumab tirumotecan and Lenvatinib, with or without Pembrolizumab (a known immunotherapy drug) and/or chemotherapy to see their effects on esophageal cancer after first treatment has failed.
What are the potential side effects?
Potential side effects may include allergic reactions, inflammation, fatigue, nausea, lowered blood cell counts increasing infection risk, liver function changes, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My esophageal cancer cannot be removed by surgery and has spread.
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My blood pressure is under control, with or without medication.
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My cancer progressed after one standard treatment including a platinum drug and anti-PD1/PD-L1 therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active brain metastases or cancer in my brain's lining.
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I haven't had serious heart problems in the last year.
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I have or had inflammatory bowel disease and need or needed medication to suppress my immune system.
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I have had Hepatitis B or currently have Hepatitis C.
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I have not had significant GI bleeding or related conditions in the past 3 months.
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My cancer has spread to nearby organs like the aorta or windpipe.
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I have lost more than 10% of my weight in the last 2 months.
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I have a severe eye condition that affects my cornea or eyelids.
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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
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I have been treated for an autoimmune disease in the last 2 years.
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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 189 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 189 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Adverse Events (AEs) During Safety Lead-in Phase
Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During Safety Lead-in Phase
+1 more
Secondary study objectives
Duration of Response (DOR)
Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase
Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab tirumotecanExperimental Treatment5 Interventions
Participants will receive 4 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.
Group II: Pembrolizumab + MK-4830 + paclitaxel or irinotecanExperimental Treatment4 Interventions
Participants receive pembrolizumab 200 mg IV once every 3 weeks (Q3W) for up to 35 cycles (cycle=21 days) or until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + paclitaxel 80-100 mg/m\^2 IV on days 1, 8, and 15 every 28-day cycle until PD or discontinuation or irinotecan 180 mg/m\^2 180 mg/m\^2 on day 1 every 14-day cycle until PD or discontinuation.
Group III: Pembrolizumab + MK-4830 + lenvatinibExperimental Treatment3 Interventions
Participants receive pembrolizumab 200 mg IV Q3W up to 35 cycles (cycle=21 days) until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + lenvatinib 20 mg oral administration every day until PD or discontinuation.
Group IV: Paclitaxel or irinotecanActive Control2 Interventions
Participants receive paclitaxel 80-100 mg/m\^2 intravenously (IV) on days 1, 8, and 15 every 28-day cycle until progressive disease (PD) or discontinuation, or irinotecan 180 mg/m\^2 IV on day 1 of every 14-day cycle until PD or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5810
Pembrolizumab
2017
Completed Phase 2
~2070
Antihistamine
2016
Completed Phase 3
~240
Irinotecan
2017
Completed Phase 3
~2580
Lenvatinib
2017
Completed Phase 4
~2040

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,783 Total Patients Enrolled
4 Trials studying Esophageal Carcinoma
922 Patients Enrolled for Esophageal Carcinoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,580 Total Patients Enrolled
3 Trials studying Esophageal Carcinoma
872 Patients Enrolled for Esophageal Carcinoma
~122 spots leftby Nov 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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