Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02834975|
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Peritoneum Cancer Epithelial Ovarian Cancer||Drug: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Single Arm Study of Combination Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Ovarian, Fallopian Tube, or Peritoneal Carcinoma Receiving Neoadjuvant Chemotherapy|
|Actual Study Start Date :||December 22, 2016|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: Pembrolizumab, Paclitaxel + Carboplatin
The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:
Pembrolizumab on Day 1 of each cycle.
Other Name: Taxol
Carboplatin IV on Day 1 of each cycle.
- Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy [ Time Frame: up to 48 months ]Measure of pathologic response
- Progression-Free Survival (PFS) Rate in Participants Receiving Protocol Therapy [ Time Frame: Up to 48 months ]Rate of Progression-Free Survival (PFS) in participants receiving protocol therapy. PFS is defined as the length of time from the date of first dose of study treatment until date of disease progression or death due to any cause, whichever comes first.
- Rate of toxicity in participants [ Time Frame: Up to 48 Months ]Safety and tolerability of the intervention will be reported as the rate of toxicity in participants as assessed by treating physician
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834975
|Contact: Marilyn Huang, MD, MSfirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Marilyn Huang, MD, MS 305-243-2233 email@example.com|
|Principal Investigator: Marilyn Huang, MD, MS|
|Principal Investigator:||Marilyn Huang, MD, MS||University of Miami|