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

February 2, 2021 updated by: Young Saing Kim, Gachon University Gil Medical Center

Phase II Trial of Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Dong-A University Hospital
        • Contact:
          • Sung Yong Oh
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
      • Seongnam-si, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Jeong-eun Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Mi So Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Unresectable, advanced or metastatic histologically confirmed leiomyosarcoma
  2. Progression during or after first-line doxorubicin-based chemotherapy (relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doxorubicin-based regimen could be considered as first-line therapy.)
  3. ECOG PS 0-2
  4. At least one measurable lesion according to RECIST v1.1
  5. Adequate organ function
  6. Life expectancy >= 3 months
  7. Negative serum or urine pregnancy test at screening for women of childbearing potential

Exclusion Criteria:

  1. Prior treatment history of anti-PD-1/PD-L1 or anti-CTLA4 treatment
  2. Receipt of 2 or more prior systemic treatments for advanced leiomyosarcoma
  3. Active or untreated brain metastases or spinal cord compression
  4. Prior treatment with gemcitabine
  5. History of major surgery within 4 weeks prior to enrollment
  6. Chemotherapy or radiotherapy within 3 weeks prior to the study drug commencement
  7. Previous malignant disease other than leiomyosarcoma within the last 5 years with the exception of basal or squamous cell carcinoma of skin or carcinoma in situ (bladder, cervical, colorectal, breast)
  8. Pregnant or lactating women
  9. HIV, HBV, or HCV infection
  10. Severe hypersensitivity or anaphylaxis to monoclonal antibody, or uncontrolled bronchial asthma
  11. Current use of immunosuppressive agent (exclusion : less than prednisone 10 mg/day or equivalent)
  12. Active autoimmune disease
  13. Clinically significant cardiovascular disease
  14. Clinically significant interstitial pneumonitis or pulmonary fibrosis
  15. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avelumab and Gemcitabine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 3 years
response rate according to RECIST v1.1
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Collaborators

Merck KGaA, Darmstadt, Germany
Chong Kun Dang Pharmaceutical Corp.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG UN18-06
  • MS100070_0069 (Other Identifier: Merck KGaA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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