Trial · NCT04082364
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
NCT04082364, Phase 2, Phase 3, Completed, MacroGenics; results first posted 2025-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer. Trials, record NCT04082364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04082364
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
- NCT number
- NCT04082364
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 82 participants, actual
- Lead sponsor
- MacroGenics
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
- Interventions
- margetuximab, Retifanlimab, Tebotelimab, Trastuzumab, Chemotherapy
- First posted
- 2019-09-09
- Last updated
- 2025-06-08
- Results first posted
- 2025-04-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Throughout the study, an average of 11 months. | Evaluation of adverse events and serious adverse events (Cohort A) |
| Primary | Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews | Throughout the study, an average of 11 months. | Percent of non MSI-H participants with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A ) based on investigator assessment. CR is defined as the disappearance of all target and non-target lesions with no new lesions appearing PR is defined as \>= to a 30% decrease in the sum of the longest dimensions of target lesions, non-progression of non- target lesions, with no new lesions appearing. CR + PR = ORR |
| Secondary | Median Progression-free Survival Using Investigator-assessed Radiology Reviews in Cohort A | Throughout the study, an average of 11 months. | Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A) based on investigator assessment |
| Secondary | Median Duration of Response in Cohort A Using Investigator-assessed Radiology Reviews | Throughout the study, an average of 11 months. | Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A) |
| Secondary | Disease Control Rate | Throughout the study, an average of 11 months. | Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B) |
| Secondary | ORR for Cohort B | Throughout the study, an average of 11 months. | Proportion of participants with best overall response of CR plus PR per RECIST 1.1 |
| Secondary | Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab | Throughout the study, an average of 11 months. | |
| Secondary | Number of Participants Who Have ADA to Retifanlimab | Throughout the study, an average of 11 months. | |
| Secondary | Number of Participants Who Have ADA to Tebotelimab | Throughout the study, an average of 11 months. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Throughout the study, an average of 11 months. | All patients who receive at least one dose of study drug in Cohort A. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews | Throughout the study, an average of 11 months. | All participants in Cohort A who received at least one dose of study treatment and had baseline radiographic tumor assessment. | percentage of participants with CR or PR | NUMBER |
| SECONDARY | Median Progression-free Survival Using Investigator-assessed Radiology Reviews in Cohort A | Throughout the study, an average of 11 months. | All participants who were assigned to treatment in Cohort A. | months | MEDIAN |
| SECONDARY | Median Duration of Response in Cohort A Using Investigator-assessed Radiology Reviews | Throughout the study, an average of 11 months. | All participants in Cohort A who achieved a confirmed CR or PR. | months | MEDIAN |
| SECONDARY | Disease Control Rate | Throughout the study, an average of 11 months. | All participants in Cohort A and B who received at least one dose of study treatment and had baseline radiographic tumor assessment. | percent of participants | NUMBER |
| SECONDARY | ORR for Cohort B | Throughout the study, an average of 11 months. | All participants in Cohort B who received at least one dose of study treatment and had baseline radiographic tumor assessment. | percent of participants with CR+PR | NUMBER |
| SECONDARY | Number of Participants Who Have Antidrug Antibodies (ADA) to Margetuximab | Throughout the study, an average of 11 months. | Participants in Cohort A and B who received margetuximab as a component of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Have ADA to Retifanlimab | Throughout the study, an average of 11 months. | Participants in Cohort A and B who received retifanlimab as a component of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Have ADA to Tebotelimab | Throughout the study, an average of 11 months. | Participants who received tebotelimab as a component of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Chemotherapy-free Arm | Any AE | 47 | Participants | |
| Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Chemotherapy-free Arm | treatment-related AE | 38 | Participants | |
| Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Chemotherapy-free Arm | severe AE | 25 | Participants | |
| Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Chemotherapy-free Arm | severe treatment-related AE | 12 | Participants | |
| Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 | Chemotherapy-free Arm | AE resulting in whole study treatment withdrawal | 8 | Participants | |
| Objective Response Rate (ORR) for Non-microsatellite Instability-high (Non-MSI-H) Participants (Cohort A) Using Investigator-assessed Radiology Reviews | Chemotherapy-free Arm | 52.1 | 95% Confidence Interval 37.2 to 66.7 | percentage of participants with CR or PR | |
| Median Progression-free Survival Using Investigator-assessed Radiology Reviews in Cohort A | Chemotherapy-free Arm | 9.8 | 95% Confidence Interval 4.60 to 14.75 | months | |
| Median Duration of Response in Cohort A Using Investigator-assessed Radiology Reviews | Chemotherapy-free Arm | 16.1 | 95% Confidence Interval 9.00 to 21.91 | months | |
| Disease Control Rate | Chemotherapy-free Arm | 83.3 | 95% Confidence Interval 69.8 to 92.5 | percent of participants | |
| Disease Control Rate | Trastuzumab and Chemotherapy Arm | 87.5 | 95% Confidence Interval 47.3 to 99.7 | percent of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Chemotherapy-free Arm | 48 | |
| Overall Study | STARTED | Part B: Margetuximab, Retifanlimab, and Chemotherapy Arm | 10 | |
| Overall Study | STARTED | Part B: Margetuximab, Tebotelimab and Chemotherapy Arm | 6 | |
| Overall Study | STARTED | Part B: Margetuximab and Chemotherapy Arm | 10 | |
| Overall Study | STARTED | Part B: Trastuzumab and Chemotherapy Arm | 8 | |
| Overall Study | COMPLETED | Part A: Chemotherapy-free Arm | 17 | |
| Overall Study | COMPLETED | Part B: Margetuximab, Retifanlimab, and Chemotherapy Arm | 7 | |
| Overall Study | COMPLETED | Part B: Margetuximab, Tebotelimab and Chemotherapy Arm | 3 | |
| Overall Study | COMPLETED | Part B: Margetuximab and Chemotherapy Arm | 2 | |
| Overall Study | COMPLETED | Part B: Trastuzumab and Chemotherapy Arm | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events495
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy-free Arm | 14 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Margetuximab, Retifanlimab, and Chemotherapy Arm | 3 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Margetuximab, Tebotelimab and Chemotherapy Arm | 5 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Margetuximab and Chemotherapy Arm | 9 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Trastuzumab and Chemotherapy Arm | 2 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy-free Arm | 0 | 48 | |
| other | Leukopenia | Blood and lymphatic system disorders | Margetuximab, Retifanlimab, and Chemotherapy Arm | 1 | 9 | |
| other | Leukopenia | Blood and lymphatic system disorders | Margetuximab, Tebotelimab and Chemotherapy Arm | 2 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Margetuximab and Chemotherapy Arm | 3 | 10 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trastuzumab and Chemotherapy Arm | 1 | 8 |
1 to 10 of 495Source ClinicalTrials.gov
See all 495 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy-free Arm | 25 | 48 |
| Total, all-cause mortality | Margetuximab, Retifanlimab, and Chemotherapy Arm | 1 | 9 |
| Total, all-cause mortality | Margetuximab, Tebotelimab and Chemotherapy Arm | 1 | 6 |
| Total, all-cause mortality | Margetuximab and Chemotherapy Arm | 2 | 10 |
| Total, all-cause mortality | Trastuzumab and Chemotherapy Arm | 1 | 8 |
| Total, other adverse events | Chemotherapy-free Arm | 47 | 48 |
| Total, other adverse events | Margetuximab, Retifanlimab, and Chemotherapy Arm | 9 | 9 |
| Total, other adverse events | Margetuximab, Tebotelimab and Chemotherapy Arm | 6 | 6 |
| Total, other adverse events | Margetuximab and Chemotherapy Arm | 10 | 10 |
| Total, other adverse events | Trastuzumab and Chemotherapy Arm | 7 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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