Carboplatin, Paclitaxel With or Without Avelumab in Advanced or Recurrent Endometrial Cancer

NCT03503786 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-11-13

No results posted yet for this study

Summary

This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer

Conditions

Interventions

DRUG

Carboplatin

Carboplatin AUC 5 i.v. every 3 weeks for 6 - 8 cycles

DRUG

Paclitaxel

Paclitaxel 175 mg/m2 i.v. every 3 weeks for 6-8 cycles

DRUG

Avelumab

Avelumab 10 mg/kg every 3 weeks for 6-8 cycles + Avelumab 10 mg/kg every 14 days until disease progression or unacceptable toxicity

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

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

  • 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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

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 NCT03503786 on ClinicalTrials.gov