Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).
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|ClinicalTrials.gov Identifier: NCT02834975|
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : July 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Carcinoma Peritoneal Carcinoma Epithelial Ovarian Cancer||Drug: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin||Phase 2|
This is a single arm, open-label, phase II study to assess pathologic objective response rate (complete response + partial response) in patients treated with pembrolizumab, paclitaxel and carboplatin for advanced stage III or IV Ovarian, Fallopian Tube, or Peritoneal Carcinoma (EOC).
Eligible patients will undergo tissue biopsies to confirm diagnosis, followed by 3 to 4 cycles of neoadjuvant chemotherapy (NACT). This regimen will be followed by interval debulking surgery (IDS). Adjuvant chemotherapy (ACT) will consist of 3 to 4 more cycles of paclitaxel with carboplatin plus pembrolizumab, once every 21 days.
|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 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Pembrolizumab, Paclitaxel + Carboplatin
Pembrolizumab on Day 1, every 21 days per protocol.
Paclitaxel on Day 1, every 21 days per protocol.
Other Name: Taxol
Carboplatin every 21 days per protocol.
- Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy [ Time Frame: Up to 48 Months ]Rate of pathologic objective response rate (pORR) in participants receiving protocol therapy.
- 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.
- To confirm safety and tolerability of combination therapy [ Time Frame: Up to 48 Months ]Rate of toxicity in participants receiving protocol therapy to confirm the safety and tolerability.
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
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Marilyn Huang, MD 305-243-2233 email@example.com|
|Principal Investigator: Marilyn Huang, MD|
|Principal Investigator:||Marilyn Huang, MD||University of Miami|