A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06123338
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be administered on an every 3-week dosing schedule
  • Trastuzumab — DRUG
    Trastuzumab will be administered on an every 3-week dosing schedule
  • Oxaliplatin — DRUG
    Oxaliplatin every 3 weeks, +/-7 days
  • Capecitabine — DRUG
    Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks
  • 5-Fluorouracil — DRUG
    5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks
  • Docetaxel — DRUG
    Docetaxel administered intravenously once every 2 weeks.
  • Nutrition questionnaires (optional) — OTHER
    will be collected (optionally)
  • stool and saliva samples (optional) — OTHER
    will be collected (optionally)

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: 2 years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital (Data Collection Only)BostonMassachusetts02114
Samuel Klempner, MD
617-724-4000
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Yelena Janjigian, MD
646-888-4186
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Yelena Janjigian, MD
646-888-4186
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Yelena Janjigian, MD
646-888-4186
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)CommackNew York11725
Yelena Janjigian, MD
646-888-4186
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Yelena Janjigian, MD
646-888-4186
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Yelena Y Janjigian, MD
646-888-4186
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Yelena Janjigian, MD
646-888-4186
University of Pennsylvania (Data Collection Only)PhiladelphiaPennsylvania19104
Ryan Massa, MD
215-316-5151
MD Anderson Cancer Center (Data Collection Only)HoustonTexas77030
Jennifer Li, MD
855-760-5921

Find similar trials in Boston, MA

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Massachusetts General Hospital (Data Collection Only)· Boston, MAMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited protocol activity)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY

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