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

ConditionsEsophageal CancerGastric AdenocarcinomaHER2 Gene Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Presence of metastatic or recurrent disease.

Has received prior treatment for esophagogastric cancer

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.

Has received prior therapy with an anti-HER2 agent

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    will be collected (optionally)

  • stool and saliva samples (optional)

    Other intervention

    will be collected (optionally)

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Esophagogastric CancerExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Event-free survival (EFS)

EFS is defined as the time from start of treatment to time of disease progression, recurrence, or death, whichever occurs first.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Genentech, Inc.

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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