Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:

* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.

* NACT: Paclitaxel on Day 1 of each cycle;
* ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.

Marilyn Huang, MD, MS

The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and Pembrolizumab may result in deeper and more durable responses compared with standard chemotherapy alone.

Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).

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

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.

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.

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.

Merck Sharp & Dohme LLC

University of Miami

Associate Professor of Clinical

The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles:

* Pembrolizumab 200mg intravenously (IV);
* Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT);
* Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT);
* Carboplatin IV area under the curve (AUC) of 6.

Pembrolizumab: Pembrolizumab on Day 1 of each cycle.

Paclitaxel: - NACT: Paclitaxel on Day 1 of each cycle;

- ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol.

Carboplatin: Carboplatin IV on Day 1 of each cycle.

Pembrolizumab, Paclitaxel + Carboplatin

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Abdulrahman Sinno, MD

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).

Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy

Progression-Free Survival (PFS)

All Treatment-related SAEs

Grade 3 or higher treatment-related SAEs

All Treatment-related AEs (excluding SAEs)

Grade 3 or higher treatment-related AEs (excluding SAEs)

All participants who received at least one dose of pembrolizumab in combination with paclitaxel and carboplatin.

Number of Participants Experiencing Treatment-related Toxicity

Overall Study

Spots Global Cancer Trial Database for Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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