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SarcomaPhase 1/2NCT03802071

A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma

A Phase 1/2 study testing Durvalumab+doxorubicin cobination in people with Sarcoma, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The yearly incidence of soft-tissue sarcomas (STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. Sarcomas of the soft tissue are a heterogeneous group of malignant tumors of mesenchymal origin that originate in connective tissue. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Sarcoma
What is being tested?
Durvalumab+doxorubicin cobination
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSouth Korea
Study dates
16 Sep 2019to 10 Aug 2022
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed STS(soft tissue sarcoma)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
  • Body weight >30kg
  • Adequate normal organ and marrow function as defined below:
  • Left ventricular ejection fraction (LVEF) ≥ 45%
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  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Must have a life expectancy of at least 12 weeks
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations

Who cannot join

  • Histologically- or cytologically-confirmed Kaposi's sarcoma or GIST
  • Previous treatment with anthracyclines
  • Participation in another clinical study with an investigational product during the last 2 weeks
  • Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 14 days prior to the first dose of study drug
  • Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or PDGFR inhibitor
  • Mean QT interval corrected for heart rate (QTc) > 480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
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  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 14 days prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 14 days of the first dose of study drug
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP(investigational product).
  • History of allogenic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness
  • Known active infection
  • History of another primary malignancy
  • History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

About this study

Official title: A Phase I/II Study of Durvalumab in Combination With Standard Chemotherapy Doxorubicin for Advanced Soft Tissue Sarcoma

The yearly incidence of soft-tissue sarcomas (STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. Sarcomas of the soft tissue are a heterogeneous group of malignant tumors of mesenchymal origin that originate in connective tissue. Local control with wide surgical resection with or without adjuvant radiation has a success rate of close to 90%. However, approximately 40% to 50% of patients with a large (>5 cm), deep, high-grade soft-tissue sarcoma eventually develop distant metastases, primarily in the lung. Therefore, overall survival of metastatic STS remained still poor, less than 1 year. Therefore, current clinical trials with various targeted agents are ongoing add on the doxorubicin monotherapy.

Investigator planned to conduct the phase I/II trial of durvalumab in combination with standard chemotherapy, doxorubicin for metastatic/recurred sofe tissue sarcoma.

Read the detailed description

The yearly incidence of soft-tissue sarcomas (STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. Sarcomas of the soft tissue are a heterogeneous group of malignant tumors of mesenchymal origin that originate in connective tissue. Local control with wide surgical resection with or without adjuvant radiation has a success rate of close to 90%. However, approximately 40% to 50% of patients with a large (>5 cm), deep, high-grade soft-tissue sarcoma (STS) eventually develop distant metastases, primarily in the lung. Therefore, overall survival (OS) of metastatic STS remained still poor, less than 1 year. Therefore, current clinical trials with various targeted agents are ongoing add on the doxorubicin monotherapy.

Durvalumab (MEDI4736) is a human monoclonal antibody that inhibits binding of PD-L1. For this orphan tumor, STS, PD-L1 may be a promising strategy and favorable toxicity may warrant further combination. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination. Regarding anti-PD-L1 treatment in STS, in phase I trial with human monoclonal antibody to PD-L1, MPDL3280A, one heavily treated synovial sarcoma patients demonstrated partial responses. In recent phase II study of pembrolizumab, PD-1 inhibitor in advanced STS among the 40 STS cases (17.5%) had responses (1 complete response and 6 partial response). Based on the study, pembrolizumab monotherapy was approved for previously treated STS in Korea.

Therefore, various clinical trials are ongoing immune checkpoint inhibitor with PDGFR inhibitors [axitinib for renal cell carcinoma (RCC), pazopanib for RCC and STS, Sorafenib for RCC, and liver cancer, sunitinib for RCC, gastrointestinal stromal tumor, and pancreatic cancer].

Conditions
Sarcoma
Being tested
Durvalumab+doxorubicin cobination
Medical subject headings
Sarcoma

What participants receive

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

  • Durvalumab+doxorubicin cobinationDrug

    Durvalumab 1500mg IV Doxorubicin 75mg/m2 IV D1 Q3weeks (up to 8cycles)

Study groups in NCT03802071
Study groupRoleWhat they receive
Durvalumab+doxorubicin combinationExperimentalNot described
Receives: Drug: Durvalumab+doxorubicin cobination

What is being measured

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

  1. adverse event

    to evaluate the safety and tolerability of durvalumab in combination with doxorubicin

    Measured: 3 weeks

Timeline

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

  1. First posted14 Jan 2019
  2. Study start16 Sep 2019
  3. Primary completion10 Aug 2022
  4. Study completion10 Aug 2022

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03802071
Sponsor's protocol ID
4-2018-0746
Status last verified
Apr 2026
First submitted
7 Jan 2019
Last updated
30 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab+doxorubicin cobination in people with Sarcoma, run by Yonsei University at 1 site 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 10 inclusion and 19 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse event (time frame: 3 weeks). 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 NCT03802071.

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 30 Apr 2026.

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