Trial · NCT02834975
Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).
NCT02834975, Phase 2, Terminated, University of Miami; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC). Trials, record NCT02834975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02834975
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).
- NCT number
- NCT02834975
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Fallopian Tube Cancer, Peritoneum Cancer, Epithelial Ovarian Cancer
- Interventions
- Pembrolizumab, Paclitaxel, Carboplatin
- First posted
- 2016-07-15
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy | Up to 48 months | The pORR will be calculated as the percentage of participants with pathologic complete response (pCR) and pathologic partial response (pPR) overall as best response. For this protocol, pathologic complete response (pCR) will be defined as no residual macroscopic or (viable) microscopic disease. Pathologic partial response (pPR) will be defined as the presence of residual (viable) microscopic tumor, and the size of the largest focus will be provided for possible outcome correlation. |
| Secondary | Progression-Free Survival (PFS) | Up to 48 months | Progression-Free Survival (PFS) is measured from date of start of treatment to the earliest occurrence of any of the following events: documented disease progression or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status which is the date of last tumor assessment according to RECIST v1.1. |
| Secondary | Number of Participants Experiencing Treatment-related Toxicity | Up to 48 Months | Safety and tolerability of the intervention will be reported as the number of participants experiencing treatment-related toxicity including serious adverse events (SAEs) and adverse events (AEs), as assessed by treating physician. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0, per physician discretion. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy | Up to 48 months | Participants who received at least one dose of pembrolizumab in combination with paclitaxel and carboplatin will have tissue collected at baseline and at the time interval debulking surgery (IDS). | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Up to 48 months | months | MEDIAN | |
| SECONDARY | Number of Participants Experiencing Treatment-related Toxicity | Up to 48 Months | All participants who received at least one dose of pembrolizumab in combination with paclitaxel and carboplatin. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy | Pembrolizumab, Paclitaxel + Carboplatin | 60 | 95% Confidence Interval 38.7 to 78.9 | percentage of participants | |
| Progression-Free Survival (PFS) | Pembrolizumab, Paclitaxel + Carboplatin | 22.5 | 95% Confidence Interval 11.9 to NA | months | |
| Number of Participants Experiencing Treatment-related Toxicity | Pembrolizumab, Paclitaxel + Carboplatin | All Treatment-related SAEs | 3 | Participants | |
| Number of Participants Experiencing Treatment-related Toxicity | Pembrolizumab, Paclitaxel + Carboplatin | Grade 3 or higher treatment-related SAEs | 1 | Participants | |
| Number of Participants Experiencing Treatment-related Toxicity | Pembrolizumab, Paclitaxel + Carboplatin | All Treatment-related AEs (excluding SAEs) | 23 | Participants | |
| Number of Participants Experiencing Treatment-related Toxicity | Pembrolizumab, Paclitaxel + Carboplatin | Grade 3 or higher treatment-related AEs (excluding SAEs) | 10 | 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 | Pembrolizumab, Paclitaxel + Carboplatin | 26 | |
| Overall Study | COMPLETED | Pembrolizumab, Paclitaxel + Carboplatin | 21 | |
| Overall Study | NOT COMPLETED | Pembrolizumab, Paclitaxel + Carboplatin | 5 |
Source ClinicalTrials.gov
Adverse events91
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 | Pembrolizumab, Paclitaxel + Carboplatin | 9 | 26 | 10 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Pembrolizumab, Paclitaxel + Carboplatin | 1 | 26 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Pembrolizumab, Paclitaxel + Carboplatin | 3 | 26 | 4 |
| other | Sinus tachycardia | Cardiac disorders | Pembrolizumab, Paclitaxel + Carboplatin | 2 | 26 | 2 |
| other | Ear pain | Ear and labyrinth disorders | Pembrolizumab, Paclitaxel + Carboplatin | 1 | 26 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab, Paclitaxel + Carboplatin | 2 | 26 | 2 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab, Paclitaxel + Carboplatin | 1 | 26 | 1 |
| other | Blurred vision | Eye disorders | Pembrolizumab, Paclitaxel + Carboplatin | 1 | 26 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab, Paclitaxel + Carboplatin | 7 | 26 | 13 |
| other | Ascites | Gastrointestinal disorders | Pembrolizumab, Paclitaxel + Carboplatin | 1 | 26 | 1 |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab, Paclitaxel + Carboplatin | 11 | 26 |
| Total, other adverse events | Pembrolizumab, Paclitaxel + Carboplatin | 26 | 26 |
| Total, serious adverse events | Pembrolizumab, Paclitaxel + Carboplatin | 6 | 26 |
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/NCT02834975
GET https://conductscience.org/api/trials/v1/NCT02834975/events?page=2