Study on Sacituzumab Tirumotecan with Pembrolizumab and Chemotherapy for Advanced Gastroesophageal Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06469944

Provider View

This clinical trial is testing a new combination of treatments for patients with advanced gastroesophageal cancer that cannot be removed by surgery. The study aims to find out if the combination of sacituzumab tirumotecan, pembrolizumab, and chemotherapy is safe and effective as a first treatment option.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with advanced gastroesophageal cancer that cannot be surgically removed. The trial will test the safety and effectiveness of combining sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs. The study is divided into two phases: the first phase will focus on safety and determining the best dose, while the second phase will evaluate how well the treatment works.

Description

The main study protocol is identified as MK-3475-U06. This trial is designed to test a new treatment combination for patients with advanced gastroesophageal cancer. The study will first assess the safety and appropriate dosage of sacituzumab tirumotecan when used with pembrolizumab and chemotherapy. Once the best dose is established, the study will proceed to evaluate the effectiveness of this treatment combination in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced gastroesophageal cancer that cannot be surgically removed.
  • Have not received any previous treatment for advanced or metastatic gastroesophageal cancer.
  • The cancer must not be HER2 positive.
  • Provide a sample of tumor tissue for analysis.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to baseline.
  • Have good organ function as determined by medical tests.
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 6 months.

Exclusion Criteria

  • Have received previous treatment for advanced gastroesophageal cancer.
  • Have lost more than 20% of body weight in the 3 months before starting the study.
  • Have severe eye conditions that affect healing.
  • Have significant nerve damage.
  • Have active inflammatory bowel disease requiring medication.
  • Have uncontrolled heart or blood vessel disease within 6 months before the study.
  • Have fluid buildup in the body that requires treatment within 2 weeks before the study.
  • Have a history of HIV infection.
  • Have received certain previous cancer treatments or investigational drugs within a specified time before the study.
  • Have active infections or other serious medical conditions.
  • Have other active cancers or brain metastases.
  • Have severe allergies to study drugs or components.
  • Have active autoimmune diseases requiring treatment in the past 2 years.
  • Have lung diseases requiring steroids.
  • Have active hepatitis B or C infections.
  • Have gastrointestinal issues affecting medication intake.
  • Have had major surgery or injury within 4 weeks before the study.
  • Have a history of organ transplant.

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