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

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Gachon University Gil Medical Center
Updated on 11 February 2021


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

Condition Leiomyosarcoma Metastatic
Treatment Avelumab and Gemcitabine
Clinical Study IdentifierNCT03536780
SponsorGachon University Gil Medical Center
Last Modified on11 February 2021


Yes No Not Sure

Inclusion Criteria

Unresectable, advanced or metastatic histologically confirmed leiomyosarcoma
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.)
At least one measurable lesion according to RECIST v1.1
Adequate organ function
Life expectancy >= 3 months
Negative serum or urine pregnancy test at screening for women of childbearing potential

Exclusion Criteria

Prior treatment history of anti-PD-1/PD-L1 or anti-CTLA4 treatment
Receipt of 2 or more prior systemic treatments for advanced leiomyosarcoma
Active or untreated brain metastases or spinal cord compression
Prior treatment with gemcitabine
History of major surgery within 4 weeks prior to enrollment
Chemotherapy or radiotherapy within 3 weeks prior to the study drug commencement
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)
Pregnant or lactating women
HIV, HBV, or HCV infection
Severe hypersensitivity or anaphylaxis to monoclonal antibody, or uncontrolled bronchial asthma
Current use of immunosuppressive agent (exclusion : less than prednisone 10 mg/day or equivalent)
Active autoimmune disease
Clinically significant cardiovascular disease
Clinically significant interstitial pneumonitis or pulmonary fibrosis
Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
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