Trial · NCT02549209
Pembro/Carbo/Taxol in Endometrial Cancer
NCT02549209, Phase 2, Completed, Daniela Matei, MD; results first posted 2021-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembro/Carbo/Taxol in Endometrial Cancer. Trials, record NCT02549209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02549209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembro/Carbo/Taxol in Endometrial Cancer
- NCT number
- NCT02549209
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Daniela Matei, MD
- Conditions
- Endometrial Cancer, Endometrial Adenocarcinoma
- Interventions
- Pembrolizumab, Paclitaxel, Carboplatin
- First posted
- 2015-09-15
- Last updated
- 2022-03-02
- Results first posted
- 2021-11-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rates (ORR) | From start of treatment Day 1 (D1) and assessed for a maximum of 18 months | Objective response rate(ORR) is defined as the percentage of subjects with a partial response or complete response according to immune-related RECIST criteria. Immune-Related Response Criteria: Complete Response(irCR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Reponse (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD |
| Secondary | Proportion of Subjects Who Experience ≥ Grade 3 Toxicity According Per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 Criteria | From time of consent to up to a maximum of 7 months(30 days following cessation of treatment ) | Proportion of subjects who experience ≥ Grade 3 toxicity regardless of relation according per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 criteria while receiving pembrolizumab in combination with standard carboplatin/paclitaxel therapy |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rates (ORR) | From start of treatment Day 1 (D1) and assessed for a maximum of 18 months | Forty-three of the enrolled patients were evaluable for efficacy using the primary endpoint of ORR. Three patients received a single dose of therapy and were not evaluable for response due to transition to hospice care, a severe allergic reaction to therapy, or no further follow up. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects Who Experience ≥ Grade 3 Toxicity According Per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 Criteria | From time of consent to up to a maximum of 7 months(30 days following cessation of treatment ) | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rates (ORR) | Investigational Treatment | 74.4 | 95% Confidence Interval 58.8 to 86.5 | percentage of participants | |
| Proportion of Subjects Who Experience ≥ Grade 3 Toxicity According Per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 Criteria | Investigational Treatment | 0.74 | proportion of participants |
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 | Investigational Treatment | 46 | |
| Overall Study | COMPLETED | Investigational Treatment | 46 | |
| Overall Study | NOT COMPLETED | Investigational Treatment | 0 |
Source ClinicalTrials.gov
Adverse events191
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 | ABDOMINAL DISTENSION | Gastrointestinal disorders | Investigational Treatment | 1 | 46 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Investigational Treatment | 15 | 46 | 15 |
| other | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Investigational Treatment | 9 | 46 | 13 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Investigational Treatment | 2 | 46 | 2 |
| other | AGITATION | Psychiatric disorders | Investigational Treatment | 3 | 46 | 4 |
| other | ALANINE AMINOTRANSFERASE INCREASED | Investigations | Investigational Treatment | 7 | 46 | 8 |
| other | ALKALINE PHOSPHATASE INCREASED | Investigations | Investigational Treatment | 8 | 46 | 12 |
| other | ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | Investigational Treatment | 3 | 46 | 3 |
| other | ALOPECIA | Skin and subcutaneous tissue disorders | Investigational Treatment | 21 | 46 | 26 |
| other | ANEMIA | Blood and lymphatic system disorders | Investigational Treatment | 36 | 46 | 92 |
1 to 10 of 191Source ClinicalTrials.gov
See all 191 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Investigational Treatment | 11 | 46 |
| Total, other adverse events | Investigational Treatment | 46 | 46 |
| Total, serious adverse events | Investigational Treatment | 16 | 46 |
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/NCT02549209
GET https://conductscience.org/api/trials/v1/NCT02549209/events?page=2