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

NCT03410784 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-03-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, M.D., Ph.D. · National Cancer Institute, Naples

  • Nicoletta Colombo, M.D. · European Institute of Oncology

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

  • Gennaro Daniele, M.D., Ph.D. · National Cancer Institute, Naples

  • Ciro Gallo, M.D. · University of Campania Luigi Vanvitelli

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410784 on ClinicalTrials.gov