Trial · NCT03914612
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
NCT03914612, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer. Trials, record NCT03914612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03914612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
- NCT number
- NCT03914612
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 813 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Dedifferentiated Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Mixed Cell Adenocarcinoma, Recurrent Endometrial Serous Adenocarcinoma, Recurrent Endometrial Undifferentiated Carcinoma, Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
- Interventions
- Carboplatin, Computed Tomography, Paclitaxel, Pembrolizumab, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2019-04-16
- Last updated
- 2026-10-21
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months. | Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events. |
| Secondary | Adverse Events With Grade 3 (or Higher) | For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months. | Assessed by Common Terminology Criteria for Adverse Events (CTCAE V5.0). The endpoint is the count of participants with an adverse event of grade 3 (or higher) by treatment group. |
| Secondary | Objective Tumor Response | For the time frame for tumor response, the interquartile range was (2.27 months, 8.66 months) and the maximum was 36.37 months. | Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1. |
| Secondary | Duration of Objective Response | For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months. | The time difference between the dates of first response and first progression; patients who do not progress are considered censored. Note: for Arm 2 (dMMR Cohort), the upper limit of the confidence interval is not able to be estimated due to an insufficient number of events. |
| Secondary | Overall Survival (OS) | Time from study entry to time of death or the date of last contact, assessed up to 5 years | Overall Survival (OS). This endpoint will be assessed by Kaplan-Meier. |
| Secondary | Quality of Life (QoL) in pMMR Patients Only | 0-54 weeks from start of treatment | QoL are collected in pMMR patients only and measured with the Function Assessment of Cancer Therapy -Endometrial Trial Outcome Index (FACT En-TOI). The FACT-En TOI scores range 0 - 120 with a larger score suggesting better or favorable state of QOL. |
| Secondary | Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC | IHC testing values (for both central and institutional) were collected at baseline. | Concordance between institutional MMR IHC testing and centralized MMR IHC. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics including the kappa statistic (e.g. Cohen's kappa coefficient). |
| Other | Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity | 0-54 weeks from start of treatment | Patient-reported neurotoxicity will be measured with FACT/GOG-Ntx subscale (short form). |
| Other | Effect of Pembrolizumab on PFS and OS by Program Death Ligand 1 (PD-L1) IHC | 5 years | Will assess the effect of pembrolizumab on PFS and OS by PD-L1 (combined positive score \[CPS\]) within proficient MMR (pMMR) and deficient MMR (dMMR) populations. The effectiveness of pembrolizumab will be compared by PD-L1 status (CPS). A formal test will be conducted by examining the interaction term between pembrolizumab treatment (yes or no) with PD-L1 status. The association between PD-L1 CPS status and MMR IHC status will be assessed with odds ratios. A test may be conducted with a Fisher's Exact Test, and confidence intervals will be provided. |
| Other | Association Between PD-L1 IHC and MMR Status | 5 years | Measures of association between PD-L1 IHC (CPS) and MMR IHC status. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics such as kappa statistics (e.g. Cohen's kappa coefficient). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months. | Randomized population (with determinate MMR status) | Months | MEDIAN |
| SECONDARY | Adverse Events With Grade 3 (or Higher) | For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months. | All randomized patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Tumor Response | For the time frame for tumor response, the interquartile range was (2.27 months, 8.66 months) and the maximum was 36.37 months. | Randomized patients with measurable disease | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Objective Response | For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months. | Randomized patients with objective tumor response | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from study entry to time of death or the date of last contact, assessed up to 5 years | |||
| SECONDARY | Quality of Life (QoL) in pMMR Patients Only | 0-54 weeks from start of treatment | The pMMR patients who provided baseline and at least one follow-up QOL assessment. | score | MEAN |
| SECONDARY | Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC | IHC testing values (for both central and institutional) were collected at baseline. | Patients from Japan were excluded. Otherwise all patients with a valid institutional MMR IHC status and a valid centralized MMR IHC status at baseline. | agreement score | NUMBER |
| OTHER_PRE_SPECIFIED | Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity | 0-54 weeks from start of treatment | |||
| OTHER_PRE_SPECIFIED | Effect of Pembrolizumab on PFS and OS by Program Death Ligand 1 (PD-L1) IHC | 5 years | |||
| OTHER_PRE_SPECIFIED | Association Between PD-L1 IHC and MMR Status | 5 years |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 7.6 | 95% Confidence Interval 6.4 to 9.9 | Months | |
| Progression-free Survival (PFS) | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | NA | 95% Confidence Interval 30.6 to NA | Months | |
| Progression-free Survival (PFS) | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 8.7 | 95% Confidence Interval 8.4 to 10.7 | Months | |
| Progression-free Survival (PFS) | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 11.7 | 95% Confidence Interval 11.0 to 15.0 | Months | |
| Adverse Events With Grade 3 (or Higher) | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 50 | Participants | ||
| Adverse Events With Grade 3 (or Higher) | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 68 | Participants | ||
| Adverse Events With Grade 3 (or Higher) | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 124 | Participants | ||
| Adverse Events With Grade 3 (or Higher) | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 151 | Participants | ||
| Objective Tumor Response | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 65 | Participants | ||
| Objective Tumor Response | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 75 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 113 | |
| Overall Study | STARTED | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 112 | |
| Overall Study | STARTED | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 295 | |
| Overall Study | STARTED | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 293 | |
| Overall Study | COMPLETED | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 113 | |
| Overall Study | COMPLETED | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 112 | |
| Overall Study | COMPLETED | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 295 | |
| Overall Study | COMPLETED | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 293 | |
| Overall Study | NOT COMPLETED | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 0 | |
| Overall Study | NOT COMPLETED | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,348
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 | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 58 | 106 | |
| other | Anemia | Blood and lymphatic system disorders | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 63 | 109 | |
| other | Anemia | Blood and lymphatic system disorders | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 144 | 274 | |
| other | Anemia | Blood and lymphatic system disorders | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 152 | 276 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 0 | 106 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 2 | 109 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 7 | 274 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 5 | 276 | |
| other | Eosinophilia | Blood and lymphatic system disorders | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 1 | 106 | |
| other | Eosinophilia | Blood and lymphatic system disorders | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 1 | 109 |
1 to 10 of 2,348Source ClinicalTrials.gov
See all 2,348 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 16 | 113 |
| Total, all-cause mortality | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 7 | 112 |
| Total, all-cause mortality | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 47 | 295 |
| Total, all-cause mortality | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 42 | 293 |
| Total, other adverse events | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 105 | 106 |
| Total, other adverse events | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 107 | 109 |
| Total, other adverse events | (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 256 | 274 |
| Total, other adverse events | (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 258 | 276 |
| Total, serious adverse events | (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 50 | 106 |
| Total, serious adverse events | (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 66 | 109 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT03914612
GET https://conductscience.org/api/trials/v1/NCT03914612/results?page=2