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A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older at time of signing informed consent.

• ECOG performance status 0-1.

• HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH\>2.0 expression.

• Complete surgical resection of the primary tumor must be achievable

• Demonstrate adequate organ function as defined in Table 1.

∙ Table 1 - Organ Function Requirements for Eligibility Hematological

• Absolute neutrophil count (ANC): ≥1,500 /mcL

• Platelets: ≥100,000 / mcL

• Hemoglobin: ≥8 g/dL Renal

• Creatinine clearance: ≥ 50 mL/minute Hepatic

• Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)

• AST and ALT: ≤ 2.5 X ULN

• Albumin: \>3 mg/dL Coagulation

• International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): \<1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

• Male participants: A male participant must agree to use contraception as detailed in Section 15.3 of this protocol during the treatment period and for at least 230 days (5 terminal half-lives of trastuzumab \[140\] plus an additional 90 days \[spermatogenesis cycle\]) after the last dose of study treatment and refrain from donating sperm during this period.

• Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

‣ Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR

⁃ A WOCBP who agrees to follow the contraceptive guidance in section 15.3 during the treatment period and for at least 170 days (140 days plus an additional 30 days \[menstruation cycle\]) after the last dose of study treatment.

Locations
United States
Massachusetts
Massachusetts General Hospital (Data Collection Only)
RECRUITING
Boston
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Pennsylvania
University of Pennsylvania (Data Collection Only)
RECRUITING
Philadelphia
Texas
MD Anderson Cancer Center (Data Collection Only)
RECRUITING
Houston
Contact Information
Primary
Yelena Janjigian, MD
janjigiy@mskcc.org
646-888-4186
Backup
Samuel Cytryn, MD
cytryns@mskcc.org
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 49
Treatments
Experimental: Esophagogastric Cancer
Participants will have a diagnosis of resectable HER2+ (IHC 3+ or IHC 2+/FISH ratio \>2.0) esophageal, GEJ or gastric cancer.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc., Merck Sharp & Dohme LLC
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov