A Phase II Clinical Trial of Pembrolizumab in Combination With Carboplatin-paclitaxel in Patients With Advanced (Stage III B-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer: MITO28/MANGO OV4 Study

National Cancer Institute, Naples13 sites in 1 country72 target enrollmentApril 1, 2018

ConditionsOvarian Cancer

InterventionsPembrolizumab Paclitaxel Carboplatin

DrugsPembrolizumab Paclitaxel Carboplatin

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Ovarian Cancer
Sponsor: National Cancer Institute, Naples
Enrollment: 72
Locations: 13
Primary Endpoint: Proportion of patients free from progression
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to assess the therapeutic efficacy and toxicity of the combination chemotherapy Paclitaxel and Carboplatin with Pembrolizumab in patients with advanced ovarian cancer. The main objective is to test whether the therapeutic intervention benefits the patient evaluating the number of subjects who are progression-free after 18 months from the beginning of the first line treatment.

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

National Cancer Institute, Naples

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In order to be eligible for participation in this trial, the subject must:
•Have a histologically confirmed diagnosis of advanced (FIGO stage IIIB, IIIC, IV) epithelial ovarian, primary peritoneal or fallopian tube cancer.
•Have evidence of residual tumor after debulking surgery OR be non-eligible neither for primary surgery nor for neoadjuvant chemotherapy followed by interval debulking surgery
•Be willing and able to provide written informed consent/assent for the trial.
•Be at least 18 years of age on day of signing informed consent.
•Have measurable disease based on RECIST 1.
•Have tumor samples available for biomarker analysis.
•Have a performance status of 0 or 1 on the ECOG Performance Scale.
•Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject:
•Is currently participating and receiving study therapy or has participated in a study of an investigational agent or investigational device and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•Has a known history of active TB (Bacillus Tuberculosis)
•Hypersensitivity to Pembrolizumab or any of its excipients.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (Grade 0 or 1 at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (Grade 0 or 1 at baseline) from adverse events due to a previously administered agent.
•Note: Subjects with Grade 1 or 2 neuropathy are an exception to this criterion and may qualify for the study.
•Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.

Arms & Interventions

First-line chemotherapy with pembrolizumab

* Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Intervention: Pembrolizumab

First-line chemotherapy with pembrolizumab

* Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Intervention: Paclitaxel

First-line chemotherapy with pembrolizumab

* Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

Intervention: Carboplatin

Outcomes

Primary Outcomes

Proportion of patients free from progression

Time Frame: 18 months from beginning of first line treatment

Secondary Outcomes

progression free survival(3 years)
overall survival(5 years)
number of patients with complete and partial responses(18 months)
worst grade toxicity per patient(evaluated every 3 weeks up to 18 months)
changes in patient-reported outcome (PRO) scores of disease-related symptoms from baseline(up to 18 months)