First Trastuzumab Deruxtecan Dose Reduction for Esophageal Adenocarcinoma (EAC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lifespan Cancer Institute, Providence, RI
Esophageal Adenocarcinoma (EAC)+4 More
Trastuzumab deruxtecan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

An open label phase II study to determine the safety and preliminary efficacy of the combination of 1-year of adjuvant trastuzumab deruxtecan and nivolumab for patients with HER2 overexpressing esophagogastric adenocarcinoma who have completed chemoradiation followed by esophagectomy.

Eligible Conditions

  • Esophageal Adenocarcinoma (EAC)
  • Gastro Esophageal Junction Cancer
  • HER-2 Protein Overexpression
  • Esophageal Neoplasms Malignant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: First dose of study treatment until time of cancer recurrence or death from any cause, whichever occurs first, maximum of 36 months

Month 36
Disease-free survival with adjuvant trastuzumab deruxtecan & nivolumab after completion of trimodality treatment for HER2+ esophageal cancer.
Month 13
Safety of the addition of adjuvant trastuzumab deruxtecan with nivolumab for patients with esophagogastric cancer who have completed trimodality treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

First Trastuzumab Deruxtecan Dose Reduction
1 of 3
Starting Trastuzumab Deruxtecan Dose
1 of 3
Second Trastuzumab Deruxtecan Dose Reduction
1 of 3
Experimental Treatment

25 Total Participants · 3 Treatment Groups

Primary Treatment: First Trastuzumab Deruxtecan Dose Reduction · No Placebo Group · Phase 2

First Trastuzumab Deruxtecan Dose ReductionExperimental Group · 2 Interventions: Trastuzumab deruxtecan, Nivolumab · Intervention Types: Drug, Drug
Starting Trastuzumab Deruxtecan DoseExperimental Group · 2 Interventions: Trastuzumab deruxtecan, Nivolumab · Intervention Types: Drug, Drug
Second Trastuzumab Deruxtecan Dose ReductionExperimental Group · 2 Interventions: Trastuzumab deruxtecan, Nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2020
Completed Phase 2
~50
Nivolumab
2014
Completed Phase 3
~5540

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first dose of study treatment until time of cancer recurrence or death from any cause, whichever occurs first, maximum of 36 months
Closest Location: Lifespan Cancer Institute · Providence, RI
2021First Recorded Clinical Trial
1 TrialsResearching Esophageal Adenocarcinoma (EAC)
2 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have stage T1N1-2 M0, T2-3N0-2 M0 disease.
You are a woman of childbearing potential.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.
HER2 overexpression defined by immunohistochemistry (IHC) 3+ or HER2 amplification by fluorescence in situ hybridization (FISH)

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.