NCT03410784

Pembrolizumab With Chemotherapy in Front Line Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

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

Timeline

• Start date: 2018-04-01
• Primary completion: 2024-08-01
• Completion: 2024-12-01
• First posted: 2018-01-25
• Last updated: 2023-03-24

Locations

13 sites across 1 country: Italy