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Anti-metabolites

Sacituzumab + Pembrolizumab + Chemotherapy 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

Is not expected to require tumor resection during the treatment course

Has not had prior systemic therapy administered in the recurrent or metastatic setting

Must not have

Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued

Has Severe hypersensitivity (Grade 3) to pembrolizumab, sacituzumab tirumotecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 55 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs for the treatment of advanced stomach, esophageal, or gastroesophageal junction cancer. The trial has two phases to evaluate the safety and effectiveness of

Who is the study for?

This trial is for adults with advanced gastroesophageal adenocarcinoma that can't be surgically removed or has spread, and who haven't had previous systemic therapy for it. They should have a life expectancy of at least 6 months, an ECOG performance status of 0 or 1 (meaning they are fully active or restricted in physically strenuous activity but ambulatory), and must have recovered from major side effects of prior therapies.

What is being tested?

The study tests Sacituzumab Tirumotecan combined with Pembrolizumab and chemotherapy drugs like Leucovorin, Capecitabine, Levoleucovorin, and 5-FU in patients with certain types of stomach cancer. It's divided into two phases: first to check safety and tolerability (and find the best dose), then to assess how effective this combination is.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal organs (due to Pembrolizumab), as well as typical chemotherapy-related issues such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not expected to need surgery to remove my tumor during treatment.

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I haven't had systemic therapy for cancer that returned or spread.

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My cancer is not HER2 positive.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is a type that started in the stomach or esophagus and has not been treated yet.

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My cancer can be measured by scans according to specific criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking a strong medication that affects liver enzymes and cannot stop.

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I am severely allergic to specific cancer drugs or their ingredients.

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I have or had lung inflammation that needed steroids.

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I am currently being treated for an infection.

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I have trouble eating or taking pills due to a blockage in my digestive system.

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I have frequent and uncontrollable diarrhea.

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I am still recovering from major surgery or have complications.

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I have had treatment for advanced stomach or esophagus cancer.

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I have or had inflammatory bowel disease and need medication to suppress my immune system.

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I have lost more than 20% of my weight in the last 3 months.

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I have a severe eye condition that affects my cornea or eyelid glands.

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I have severe nerve damage in my hands or feet.

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I have been treated with a TROP2-targeted therapy before.

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I have been treated with a specific type of chemotherapy called topoisomerase 1 inhibitor.

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I have been treated with drugs targeting immune checkpoints.

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I had radiotherapy less than 2 weeks ago or need steroids for radiation side effects.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have active brain metastases or cancer in the lining of my brain.

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I have been treated for an autoimmune disease in the last 2 years.

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I have active hepatitis B or C.

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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 55 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 55 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blind Independent Review Committee (BICR)

Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE

Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

+1 more

Secondary study objectives

Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

Incidence of Antidrug Antibodies (ADA) to sacituzumab tirumotecan (sac-TMT, MK-2870)

Number of Participants Who Discontinue Study Treatment Due to an AE

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab plus Sacituzumab Tirumotecan plus ChemotherapyExperimental Treatment4 Interventions

Participants will receive sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 6 week cycle until discontinuation, pembrolizumab 400 mg via IV injection on day 1 of every 6 week cycle for up to 18 cycles (up to \~2 years) AND investigator's choice of capecitabine 1000 mg/m\^2 orally twice daily for 14 days Q3W OR 5-FU 400 mg/\^2 via bolus IV plus 2400 mg/m\^2 continuous IV once Q2W.

Group II: Pembrolizumab plus ChemotherapyActive Control5 Interventions

Participants will receive pembrolizumab 400 mg via intravenous (IV) injection on day 1 of every 6 week cycle for up to 18 cycles (up to \~2 years) AND investigator's choice of CAPOX chemotherapy (capecitabine 1000 mg/m\^2 orally twice daily for 14 days every 3 weeks (Q3W) and oxaliplatin 130 mg/m\^2 via IV infusion Q3W) OR mFOLFOX6 chemotherapy (oxaliplatin 85 mg/m\^2 via IV infusion Q3W; 5-FU 400 mg/\^2 via bolus IV plus 2400 mg/m\^2 continuous IV once every 2 weeks (Q2W); and leucovorin 400 mg/m\^2 via IV infusion Q2W OR levoleucovorin 200 mg/m\^2 Q2W).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Capecitabine

2013

Completed Phase 3

~4280