Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

November 3, 2016

Primary Completion Date

June 1, 2022

Study Completion Date

March 14, 2023

Conditions
Esophageal CancerGastric Cancer
Interventions
DRUG

pembrolizumab

DRUG

trastuzumab

DRUG

capecitabine

DRUG

cisplatin

DRUG

Oxaliplatin

Oxaliplatin may be administered instead, at a dose of 130 mg/m2/day as an I.V.over approximately 2 hours on Day 1 every 21-day cycles, up to a maximum of 8 cycles in the absence of disease progression or until other withdrawl criteria are met. Patients may begin with reduced dose of oxaliplatin 104 mg/m2 as starting dose if deemed necessary per the treating physician discretion. Oxaliplatin will be administered after the completion of the pembrolizumab infusion.

DRUG

5-Fluorouracil

Only for patients unable to take oral medications (because of certain circumstances such as malabsorption, difficulty swallowing, or other conditions that could affect intake of oral capecitabine medication), 5-FU may be administered instead, at a dose of 800 mg/m2/day as a continuous infusion over 5 days (Day 1 to Day 5 of each cycle), every 21 days. This decision should be made prior to registration by the treating physician; switching from capecitabine to 5-FU, or vice versa, will not be allowed during the study. 5-FU will be administered after completion of the cisplatin infusion.

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

Memorial Sloan Kettering Rockville Centre, Rockville Centre

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT02954536 - Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer | Biotech Hunter | Biotech Hunter