Study of Pembrolizumab with Trastuzumab and Chemotherapy for Esophagogastric Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06123338

Provider View

This clinical trial is exploring whether adding the drugs trastuzumab and pembrolizumab to standard chemotherapy can effectively treat esophagogastric cancer that can be surgically removed and is HER2 positive.

Patient Parameters

Program Overview

The aim of this study is to determine if combining the drugs trastuzumab and pembrolizumab with standard chemotherapy is an effective treatment for patients with HER2 positive esophagogastric cancer that can be surgically removed. Researchers want to see if this combination can help control the cancer better than chemotherapy alone.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status, with an ECOG performance score of 0 or 1.
  • Have HER2 positive esophageal, gastroesophageal junction, or gastric cancer confirmed by specific tests.
  • The primary tumor must be able to be completely removed by surgery.
  • Must have adequate organ function, including:
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 100,000/mcL.
    • Hemoglobin level of at least 8 g/dL.
    • Serum creatinine within normal limits.
    • Liver function tests within specified limits.
    • Blood clotting times within normal limits unless on anticoagulants.
  • Male participants must agree to use contraception during treatment and for 230 days after the last dose.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception during treatment and for 170 days after the last dose if they are of childbearing potential.

Exclusion Criteria

  • Have metastatic or recurrent esophagogastric cancer.
  • Have received previous treatment for esophagogastric cancer.
  • Have been treated with anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents before.
  • Have been treated with anti-HER2 agents before.
  • Have a heart ejection fraction below 50% unless cleared by a cardiologist.
  • Are currently in another clinical trial or have been in one recently.
  • Have an immune deficiency or are on immunosuppressive therapy.
  • Have a history of active tuberculosis.
  • Are allergic to pembrolizumab or its ingredients.
  • Have had another cancer in the past 3 years, except for certain skin cancers.
  • Have active brain metastases or cancer in the brain lining.
  • Have active lung inflammation or infection.
  • Have any condition that could interfere with the study.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have had a positive pregnancy test before starting the study.
  • Have had a tissue or organ transplant.
  • Have active autoimmune or inflammatory disorders, with some exceptions.
  • Have HIV, active Hepatitis B, or Hepatitis C.
  • Have received a live vaccine recently.
  • Are unwilling to give consent or follow the study protocol.

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