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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03536780
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : February 15, 2019
Merck KGaA, Darmstadt, Germany
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
Young Saing Kim, Gachon University Gil Medical Center

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

Condition or disease Intervention/treatment Phase
Leiomyosarcoma Metastatic Drug: Avelumab and Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : February 28, 2022

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 100 minutes on Days 1, 8, and 15 of each 28-day cycle

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 3 years ]
    response rate according to RECIST v1.1

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03536780

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Contact: Young Saing Kim, MD, PhD +82-032-460-3231

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Korea, Republic of
Dong-a University Hospital Recruiting
Busan, Korea, Republic of
Contact: Sung Yong Oh         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Young Saing Kim, MD    +82-32-460-3231   
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jeeyun Lee         
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hyo Song Kim         
Sponsors and Collaborators
Gachon University Gil Medical Center
Merck KGaA, Darmstadt, Germany
Chong Kun Dang Pharmaceutical Corp.

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Responsible Party: Young Saing Kim, Assistant Professor, Gachon University Gil Medical Center Identifier: NCT03536780    
Other Study ID Numbers: KCSG UN18-06
MS100070_0069 ( Other Identifier: Merck KGaA )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs