Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction

Part of paid clinical trials in New York, New York.

Sponsor
Brown University
Study ID
NCT05480384
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Esophageal Adenocarcinoma
  • Esophageal Cancer
  • Gastroesophageal-junction Cancer
  • HER-2 Protein Overexpression

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab, 360 mg IV every 3 weeks for 17 doses (12 months)
  • Trastuzumab deruxtecan — DRUG
    Given in combination with Nivolumab.

Study Details

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.

Key Dates

Start date
Jul 14, 2023
Status verified
Apr 2026
Primary completion
May 5, 2025
Completion
May 31, 2026

Study Design

Enrollment
1 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Starting Trastuzumab Deruxtecan Dose
    Trastuzumab deruxtecan, 6.4 mg/kg IV every 3 weeks for 17 doses (12 months)
  • Experimental: First Trastuzumab Deruxtecan Dose Reduction
    Trastuzumab deruxtecan, 5.4 mg/kg IV every 3 weeks for 17 doses (12 months)
  • Experimental: Second Trastuzumab Deruxtecan Dose Reduction
    Trastuzumab deruxtecan, 4.4 mg/kg IV every 3 weeks for 17 doses (12 months)

Primary Outcome Measure

Safety of the addition of adjuvant trastuzumab deruxtecan with nivolumab for patients with esophagogastric cancer who have completed trimodality treatment [ Time Frame: First dose of study treatment, through 30-days post last dose of drug, approximately 13 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/New York-PresbyterianNew YorkNew York10021-
Lifespan Cancer InstituteProvidenceRhode Island02903-

Find similar trials in New York, NY

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Weill Cornell Medicine/New York-Presbyterian· New York, NYLifespan Cancer Institute· Providence, RI

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