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Leiomyosarcoma MetastaticPhase 2EAGLESNCT03536780

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

A Phase 2 study testing Avelumab and Gemcitabine in people with Leiomyosarcoma Metastatic, run by Gachon University Gil Medical Center at 6 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 2 trial of avelumab plus gemcitabine in advanced leiomyosarcoma as a second line treatment Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Leiomyosarcoma Metastatic
What is being tested?
Avelumab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
6 sitesSouth Korea
Study dates
1 Oct 2018to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

Young Saing Kim, MD, PhD contact

+82-032-460-3231

zoomboom@gilhospital.com

6 sites in 1 country

South Korea6 sites, 6 recruiting

  • Dong-a University Hospital

    Busan

    Sung Yong Oh

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Young Saing Kim, MD, +82-32-460-3231, zoomboom@gilhospital.com

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si

    Yu Jung Kim

    Recruiting

  • Asan Medical Center

    Seoul

    Jeong-eun Kim

    Recruiting

  • Samsung Medical Center

    Seoul

    Jeeyun Lee

    Recruiting

  • Seoul National University Hospital

    Seoul

    Mi So Kim

    Recruiting

Other trials in South Korea

About this study

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

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

Being tested
Avelumab and Gemcitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avelumab and GemcitabineDrug

    • 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
Study groups in NCT03536780
Study groupRoleWhat they receive
Avelumab and GemcitabineExperimentalNot described
Receives: Drug: Avelumab and Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    response rate according to RECIST v1.1

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03536780
Sponsor's protocol ID
KCSG UN18-06
Other IDs
MS100070_0069
Acronym
EAGLES
Status last verified
Feb 2021
First submitted
10 May 2018
Last updated
4 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab and Gemcitabine in people with Leiomyosarcoma Metastatic, run by Gachon University Gil Medical Center at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Young Saing Kim, MD, PhD (+82-032-460-3231, zoomboom@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03536780, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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