Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.

Part A is a single-arm cohort (Cohort A, 40 to 110 patients) will evaluate safety and efficacy of margetuximab plus retifanlimab.

Part B Part 1 has 4 arms (50 patients/arm). Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.

Official Title

A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer

Keywords

Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer, Stomach Neoplasms, Trastuzumab, Margetuximab, Retifanlimab, Tebotelimab, Chemotherapy

Eligibility

Locations

  • UCLA School of Medicine
    Santa Monica California 90404 United States
  • Norris Comprehensive Cancer Center (USC)
    Los Angeles California 90033 United States
  • City of Hope Comprehensive Cancer Center - Duarte
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MacroGenics
ID
NCT04082364
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
About 82 people participating
Last Updated