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

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

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

Conditions
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Leiomyosarcoma Metastatic

Intervention / Treatment
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* Drug: Avelumab and Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.) ECOG PS 0-2 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avelumab and Gemcitabine<br> | Drug: Avelumab and Gemcitabine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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