Leiomyosarcoma Metastatic
Conditions
Brief summary
A Phase 2 trial of avelumab plus gemcitabine in advanced leiomyosarcoma as a second line treatment
Interventions
DRUGAvelumab 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
Merck KGaA, Darmstadt, Germany
Chong Kun Dang Pharmaceutical Corp.
Gachon University Gil Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 3 years | response rate according to RECIST v1.1 |
Countries
South Korea
Contacts
Primary ContactYoung Saing Kim, MD, PhD
Outcome results
None listed