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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
MAHOGANY Trial 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.Check my eligibility
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).See study design
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.
MAHOGANY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and is HER2 positive.
Select...
I had treatment before or after surgery and have been disease-free for at least 6 months.
Select...
I am in Cohort B with HER2-positive cancer, regardless of my PD-L1 status.
Select...
My cancer is HER2-positive and PD-L1-positive.
Select...
I can provide a sample of my tumor for testing.
Select...
I am getting treatment targeting HER2 and my cancer's HER2 status has been tested.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My blood tests show my organs are working well.
MAHOGANY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Disease control rate
Duration of response
Number of patients who have ADA to retifanlimab
+4 moreSide effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Neutropenia
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Vomiting
14%
White blood cell count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
10%
Neutrophil count decreased
5%
Diarrhea
5%
Musculoskeletal pain
5%
Dizziness
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
MAHOGANY 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
Retifanlimab
Not yet FDA approved
Margetuximab
FDA approved
Find a Location
Who is running the clinical trial?
Zai Lab (Shanghai) Co., Ltd.Industry Sponsor
28 Previous Clinical Trials
3,599 Total Patients Enrolled
MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,201 Total Patients Enrolled
Minori K. Rosales, MD, PhDStudy DirectorMacroGenics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced, cannot be surgically removed, and is HER2 positive.My cancer is MSI-H.I had treatment before or after surgery and have been disease-free for at least 6 months.I am in Cohort B with HER2-positive cancer, regardless of my PD-L1 status.My cancer is HER2-positive and PD-L1-positive.I can provide a sample of my tumor for testing.My cancer has spread to my brain.I am getting treatment targeting HER2 and my cancer's HER2 status has been tested.I have received immunotherapy before surgery or alongside other treatments.I haven't needed treatment for another cancer in the last 5 years.I do not have serious heart, lung, or stomach problems.I am fully active or restricted in physically strenuous activity but can do light work.I have had a transplant of stem cells or an organ from another person.My blood tests show my organs are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy-free arm
- Group 2: Margetuximab, retifanlimab, and chemotherapy arm
- Group 3: Margetuximab, tebotelimab and chemotherapy arm
- Group 4: Margetuximab and chemotherapy arm
- Group 5: Trastuzumab and chemotherapy arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what types of cancer is chemotherapy the primary form of treatment?
"Breast, high risk of recurrence, and metastatic breast cancer with HER2 positive can be treated using chemotherapy."
Answered by AI
Are there any other notable cases of Chemotherapy being used in a medical setting?
"There are a total of 229 clinical trials that are currently studying chemotherapy. Out of those, 54 are in Phase 3. Although many studies for this treatment originate in Seattle, WA, there are actually 15529 locations conducting these trials."
Answered by AI
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