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Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment

NCT03536780 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-02-04

No results posted yet for this study

Summary

A Phase 2 trial of avelumab plus gemcitabine in advanced leiomyosarcoma as a second line treatment

Conditions

  • Leiomyosarcoma Metastatic

Interventions

DRUG

Avelumab and Gemcitabine

* Avelumab: 10 mg/kg by IV infusion over 1 hour, every 2 weeks * Gemcitabine: 1000 mg/m2 by IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Chong Kun Dang Pharmaceutical Corp.

    collaborator INDUSTRY

  • Gachon University Gil Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

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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 NCT03536780 on ClinicalTrials.gov