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Combination Therapy for Gastric Cancer (MAHOGANY Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by MacroGenics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma

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

Must not have

History of allogeneic stem cell or tissue/solid organ transplant

Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of two drugs, margetuximab and retifanlimab, as a possible treatment for stomach or gastroesophageal junction cancer.

Who is the study for?

This trial is for adults with untreated advanced HER2+ gastric or gastroesophageal junction cancer. They should have a good performance status, measurable tumor lesions, and no central nervous system metastases. Prior systemic treatment is okay if there's been a disease-free period of at least 6 months.

What is being tested?

The study tests combinations of margetuximab with retifanlimab or tebotelimab plus chemotherapy against trastuzumab with chemo in two parts: initial safety/efficacy assessment (Part A) and randomized comparison to find the best combo (Parts B1 & B2).

What are the potential side effects?

Potential side effects include immune-related reactions due to retifanlimab or tebotelimab, typical chemotherapy side effects like nausea, fatigue, hair loss, increased infection risk, and infusion-related reactions from monoclonal antibodies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and is HER2 positive.

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I am in Cohort B with HER2-positive cancer, regardless of my PD-L1 status.

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My cancer is HER2-positive and PD-L1-positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a transplant of stem cells or an organ from another person.

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I do not have serious heart, lung, or stomach problems.

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I have received immunotherapy before surgery or alongside other treatments.

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My cancer is MSI-H.

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events of margetuximab plus retifanlimab as assessed by CTCAE v5.0

Objective response rate (ORR) for non-microsatellite instability-high (non-MSI-H) patients (Cohort A)

Secondary study objectives

Disease control rate

Duration of response

ORR for Cohort B

+1 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

Anaemia

14%

Vomiting

14%

Neutropenia

14%

Alanine aminotransferase increased

14%

White blood cell count decreased

14%

Thrombocytopenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Musculoskeletal pain

Dizziness

Diarrhea

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Margetuximab, tebotelimab and chemotherapy armExperimental Treatment3 Interventions

margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Group II: Margetuximab, retifanlimab, and chemotherapy armExperimental Treatment3 Interventions

margetuximab plus retifanlimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Group III: Margetuximab and chemotherapy armExperimental Treatment2 Interventions

margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Group IV: Chemotherapy-free armExperimental Treatment2 Interventions

margetuximab plus retifanlimab

Group V: Trastuzumab and chemotherapy armActive Control2 Interventions

Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Margetuximab

FDA approved

Retifanlimab

Not yet FDA approved

0 / 8Eligibility criteria met