Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Com… (NCT05480384) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction
United States1 participantsStarted 2023-07-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pathologically confirmed primary adenocarcinoma of the esophagus, esophagogastric junction or (Stomach involvement is allowed.).
✓. HER2 overexpression defined by immunohistochemistry (IHC) 3+ or HER2 amplification by fluorescence in situ hybridization (FISH). This may be defined by local or commercial laboratories
✓. Completed trimodality treatment with chemoradiation followed by esophagectomy and had an R0 resection but did not achieve a complete pathologic response.
✓. 4 - 12 weeks after esophagectomy.
✓. Prior to trimodality treatment had stage T1N1-2 M0, T2-3N0-2 M0 disease.
✓. Age ≥ 18
✓. ECOG performance status 0-1
✓. For women of childbearing potential, a negative serum pregnancy test within 7 days prior to registration
Exclusion criteria
✕. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
✕. Patients with a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI.
What they're measuring
1
Safety of the addition of adjuvant trastuzumab deruxtecan with nivolumab for patients with esophagogastric cancer who have completed trimodality treatment
Timeframe: First dose of study treatment, through 30-days post last dose of drug, approximately 13 months
✕. Corrected QT interval (QTcF) prolongation to \> 470 msec (females) or \>450 msec (males) based on average of the screening triplicate12-lead ECG.
✕. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
✕. History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
✕. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
✕. Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Subjects with past or resolved hepatitis B virus (HBV) infection who are anti-HBc positive (+) are eligible only if they are HBsAg negative (-).
✕. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.