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

ClinicalTrials.gov ID

NCT03536780

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

38Estimated

Last Update Posted

Feb 4, 2021Actual

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2022Estimated

Official Title

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

Brief Summary

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

• Leiomyosarcoma Metastatic

• Avelumab and Gemcitabine

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Merck KGaA, Darmstadt, GermanyINDUSTRY

Chong Kun Dang Pharmaceutical Corp.INDUSTRY

zoomboom@gilhospital.com+82-32-460-3231

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