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Status unknownNCT03536780EAGLESUpdated Feb 4, 2021

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

A Phase 2 interventional study of Avelumab and Gemcitabine in Leiomyosarcoma Metastatic, sponsored by Gachon University Gil Medical Center. Status unknown at 6 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Gachon University Gil Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
20 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Leiomyosarcoma Metastatic

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In context

Leiomyosarcoma

147 studies on the registry are indexed under Leiomyosarcoma; 33 are open to participants now.

This study's planned enrollment of 38 is below the median of 45 across 121 interventional studies indexed under Leiomyosarcoma.

Browse Leiomyosarcoma studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Avelumab and Gemcitabine

    Drug: Avelumab and Gemcitabine

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

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What researchers measure

Primary outcomes

  1. Overall Response Rate

    response rate according to RECIST v1.1

    Time frame: 3 years

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Study locations

6 of 6 sites recruiting
  • Dong-a University Hospital
    Busan, Korea, Republic of
    • Sung Yong Oh · Contact
    Recruiting
  • Gachon University Gil Medical Center
    Incheon, Korea, Republic of
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Korea, Republic of
    • Yu Jung Kim · Contact
    Recruiting
  • Asan Medical Center
    Seoul, Korea, Republic of
    • Jeong-eun Kim · Contact
    Recruiting
  • Samsung Medical Center
    Seoul, Korea, Republic of
    • Jeeyun Lee · Contact
    Recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    • Mi So Kim · Contact
    Recruiting
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References and documents

Publications

  • Clark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005 Aug 18;353(7):701-11. doi: 10.1056/NEJMra041866. No abstract available. PubMed 16107623 ↗
  • Linch M, Miah AB, Thway K, Judson IR, Benson C. Systemic treatment of soft-tissue sarcoma-gold standard and novel therapies. Nat Rev Clin Oncol. 2014 Apr;11(4):187-202. doi: 10.1038/nrclinonc.2014.26. Epub 2014 Mar 18. PubMed 24642677 ↗
  • Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31. doi: 10.1200/JCO.2002.11.050. PubMed 12065559 ↗
  • Seddon B, Strauss SJ, Whelan J, Leahy M, Woll PJ, Cowie F, Rothermundt C, Wood Z, Benson C, Ali N, Marples M, Veal GJ, Jamieson D, Kuver K, Tirabosco R, Forsyth S, Nash S, Dehbi HM, Beare S. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1397-1410. doi: 10.1016/S1470-2045(17)30622-8. Epub 2017 Sep 4. PubMed 28882536 ↗
  • Pautier P, Floquet A, Penel N, Piperno-Neumann S, Isambert N, Rey A, Bompas E, Cioffi A, Delcambre C, Cupissol D, Collin F, Blay JY, Jimenez M, Duffaud F. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study). Oncologist. 2012;17(9):1213-20. doi: 10.1634/theoncologist.2011-0467. Epub 2012 Aug 20. PubMed 22907974 ↗
  • Dunn GP, Bruce AT, Ikeda H, Old LJ, Schreiber RD. Cancer immunoediting: from immunosurveillance to tumor escape. Nat Immunol. 2002 Nov;3(11):991-8. doi: 10.1038/ni1102-991. PubMed 12407406 ↗
  • Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4. Erratum In: Lancet Oncol. 2017 Dec;18(12):e711. doi: 10.1016/S1470-2045(17)30864-1. Lancet Oncol. 2018 Jan;19(1):e8. doi: 10.1016/S1470-2045(17)30926-9. PubMed 28988646 ↗
  • Kelly K, Infante JR, Taylor MH, Patel MR, Wong DJ, Iannotti N, Mehnert JM, Loos AH, Koch H, Speit I, Gulley JL. Safety profile of avelumab in patients with advanced solid tumors: A pooled analysis of data from the phase 1 JAVELIN solid tumor and phase 2 JAVELIN Merkel 200 clinical trials. Cancer. 2018 May 1;124(9):2010-2017. doi: 10.1002/cncr.31293. Epub 2018 Feb 22. PubMed 29469949 ↗
  • Galluzzi L, Senovilla L, Zitvogel L, Kroemer G. The secret ally: immunostimulation by anticancer drugs. Nat Rev Drug Discov. 2012 Feb 3;11(3):215-33. doi: 10.1038/nrd3626. PubMed 22301798 ↗
  • Chen G, Emens LA. Chemoimmunotherapy: reengineering tumor immunity. Cancer Immunol Immunother. 2013 Feb;62(2):203-16. doi: 10.1007/s00262-012-1388-0. Epub 2013 Feb 7. PubMed 23389507 ↗
  • Kim JM, Chen DS. Immune escape to PD-L1/PD-1 blockade: seven steps to success (or failure). Ann Oncol. 2016 Aug;27(8):1492-504. doi: 10.1093/annonc/mdw217. Epub 2016 May 20. PubMed 27207108 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03536780
Lead sponsor
Gachon University Gil Medical Center
Collaborators
Merck KGaA, Darmstadt, Germany, Chong Kun Dang Pharmaceutical Corp.
Responsible party
Young Saing Kim (Associate Professor, Gachon University Gil Medical Center) — Principal investigator
First posted
May 25, 2018
Start date
Oct 1, 2018
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Feb 4, 2021

Study contacts

Young Saing Kim, MD, PhD
Contact
zoomboom@gilhospital.com
+82-032-460-3231

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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