Study on Trastuzumab Deruxtecan and Nivolumab for Patients Free of Disease After Treatment for HER-2 Positive Esophageal and Gastroesophageal Cancers

Sponsor: Brown University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05480384

Provider View

This clinical trial is testing the safety and effectiveness of a combination of two drugs, trastuzumab deruxtecan and nivolumab, for patients with HER-2 positive esophageal and gastroesophageal cancers who have completed initial treatments and surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and initial effectiveness of using trastuzumab deruxtecan and nivolumab for one year in patients with HER-2 positive esophageal and gastroesophageal cancers. These patients have already completed chemotherapy, radiation, and surgery. The study will involve receiving these medications through an IV every 21 days for a total of 17 doses over a year.

Description

This study is designed to test the safety and early effectiveness of a combination treatment using trastuzumab deruxtecan and nivolumab for patients with HER-2 positive esophageal and gastroesophageal cancers. Participants will receive these medications through an IV every 21 days for a total of 17 doses over one year. The goal is to see if this combination can help prevent the cancer from returning after patients have completed their initial treatments, which include chemotherapy, radiation, and surgery.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the esophagus or gastroesophageal junction, with possible stomach involvement.
  • Cancer must show HER2 overexpression, confirmed by specific lab tests.
  • Completed chemotherapy, radiation, and surgery, with no remaining cancer detected but not a complete response.
  • 4 to 12 weeks post-surgery.
  • Initially had cancer stages T1N1-2 M0 or T2-3N0-2 M0 before treatment.
  • Aged 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Women of childbearing potential must have a negative pregnancy test before joining.
  • Must agree to use effective non-hormonal birth control during the study and for a period after.
  • Able to understand and willing to sign a consent form.
  • Heart function must be at least 50%.
  • Adequate organ and bone marrow function based on recent tests.
  • Women must not be pregnant or breastfeeding and must use effective contraception.
  • Men must use condoms and avoid fathering a child during and after the study.
  • Women must not donate eggs during and after the study.

Exclusion Criteria

  • Substance abuse or medical conditions that could interfere with the study.
  • Recent heart attack or severe heart conditions.
  • Abnormal heart rhythms or conditions requiring treatment.
  • Lung diseases or conditions affecting the lungs.
  • Uncontrolled infections requiring IV treatment.
  • Active immune system disorders or infections like HIV or hepatitis.
  • Recent live vaccine.
  • Unresolved side effects from previous cancer treatments.
  • Allergies to study drugs.
  • Pregnant or breastfeeding women.
  • Multiple cancers within the last 3 years, except certain treated cancers.
  • Fluid buildup requiring drainage.
  • Previous treatment with similar drugs.
  • Active autoimmune diseases requiring treatment.
  • Conditions requiring high-dose steroids or immunosuppressive drugs.
  • Any other condition that could prevent safe participation.

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