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
Description
Brief 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 has 2 subparts. Cohort B1 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. The most
effective combination with margetuximab from Cohort B1 will be used in Cohort B2.
Cohort B2 has 2 arms (250 patients/arm). Patients will be randomized to margetuximab plus
retifanlimab or tebotelimab plus chemotherapy, or to trastuzumab plus chemotherapy.
Phase
N/AInclusion and Exclusion Criteria
- - Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
- Prior systemic perioperative treatment is allowed; however the patient must have had a disease-free interval of at least 6 months from end of chemo/surgery
- Patients receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility
- Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review
- Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment. - Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing - Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1 - Life expectancy ≥ 6 months - At least one radiographically measurable target lesion - Acceptable laboratory parameters and adequate organ function Key
- Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions
- Patients with known MSI-H status
- History of allogeneic stem cell or tissue/solid organ transplant
- Central nervous system metastases
- Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise
- Prior neoadjuvant or adjuvant treatment with immunotherapy
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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