Trial · NCT03835819
A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)
NCT03835819, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2025-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC). Trials, record NCT03835819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03835819
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)
- NCT number
- NCT03835819
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Endometrial Cancer
- Interventions
- Pembrolizumab, IMGN853
- First posted
- 2019-02-11
- Last updated
- 2026-06-01
- Results first posted
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 6 months | The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR. The ORR is therefore reported as the percentage of participants who achieved a CR or PR per RECIST v1.1. |
| Primary | Progression-Free Survival at 6 Months (PFS6) | 6 months | Progression-free survival at 6 months was determined by the frequency of patients who survived progression-free for at least 6 months after initiating study treatment by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. |
| Secondary | Progression-free Survival | Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. | Progression-free survival was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The distribution of progression-free times will be estimated using Kaplan-Meier analysis. |
| Secondary | Overall Survival | Participants are followed for survival status from registration through up to 3 years after removal from study intervention | Overall survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive. The distribution of overall survival times will be estimated using Kaplan-Meier analysis. |
| Secondary | Duration of Response | Interval from best overall response to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. | Duration of response (DoR) is defined as time from best overall response to the time of disease progression. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | 6 months | Among 18 patients, 5 had a confirmed response. Confirmed ORR is 28%, with 95% confidence interval of \[ 10%, 53%\]. | percentage of participants | NUMBER |
| PRIMARY | Progression-Free Survival at 6 Months (PFS6) | 6 months | 4 patients were alive and progression-free at 6 months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. | months | MEDIAN | |
| SECONDARY | Overall Survival | Participants are followed for survival status from registration through up to 3 years after removal from study intervention | months | MEDIAN | |
| SECONDARY | Duration of Response | Interval from best overall response to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. | Due to the small number of responses, reporting the confidence interval or interquartile range is not meaningful. Out of the 5 confirmed responders, 2 experienced events (progression or death), while 3 were censored. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | IMGN853 + Pembrolizumab | 28 | 95% Confidence Interval 10 to 53 | percentage of participants | |
| Progression-Free Survival at 6 Months (PFS6) | IMGN853 + Pembrolizumab | 4 | Participants | ||
| Progression-free Survival | IMGN853 + Pembrolizumab | 2.73 | 95% Confidence Interval 1.2 to 4.5 | months | |
| Overall Survival | IMGN853 + Pembrolizumab | 11.3 | 95% Confidence Interval 3.32 to NA | months | |
| Duration of Response | IMGN853 + Pembrolizumab | 7.1 | Full Range 2.76 to 18.14 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMGN853 + Pembrolizumab | 18 | |
| Overall Study | COMPLETED | IMGN853 + Pembrolizumab | 18 | |
| Overall Study | NOT COMPLETED | IMGN853 + Pembrolizumab | 0 |
Source ClinicalTrials.gov
Adverse events120
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 | Anemia | Blood and lymphatic system disorders | IMGN853 + Pembrolizumab | 10 | 18 | |
| other | Sinus tachycardia | Cardiac disorders | IMGN853 + Pembrolizumab | 1 | 18 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMGN853 + Pembrolizumab | 1 | 18 | |
| other | Adrenal insufficiency | Endocrine disorders | IMGN853 + Pembrolizumab | 1 | 18 | |
| other | Hyperthyroidism | Endocrine disorders | IMGN853 + Pembrolizumab | 1 | 18 | |
| other | Hypothyroidism | Endocrine disorders | IMGN853 + Pembrolizumab | 1 | 18 | |
| other | Blurred vision | Eye disorders | IMGN853 + Pembrolizumab | 8 | 18 | |
| other | Cataract | Eye disorders | IMGN853 + Pembrolizumab | 1 | 18 | |
| other | Dry eye | Eye disorders | IMGN853 + Pembrolizumab | 2 | 18 | |
| other | Eye disorders - Other, specify | Eye disorders | IMGN853 + Pembrolizumab | 1 | 18 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMGN853 + Pembrolizumab | 12 | 18 |
| Total, other adverse events | IMGN853 + Pembrolizumab | 18 | 18 |
| Total, serious adverse events | IMGN853 + Pembrolizumab | 4 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03835819
GET https://conductscience.org/api/trials/v1/NCT03835819/events?page=2