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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 189 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5450

Pembrolizumab

2017

Completed Phase 3

~3130