New hope for rare sarcoma? drug combo tested in 44 patients
NCT ID NCT03802071
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the immunotherapy drug durvalumab to standard chemotherapy (doxorubicin) could help people with advanced soft tissue sarcoma that has spread or come back. The trial included 44 adults whose cancer could be measured and who were healthy enough for treatment. The main goal was to check safety and see if the combination works better than chemo alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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44 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Aug 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed STS(soft tissue sarcoma) 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 4. Body weight \>30kg 5. Adequate normal organ and marrow function as defined below: 6. Left ventricular ejection fraction (LVEF) ≥ 45% 7. 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. 8. 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. 9. Must have a life expectancy of at least 12 weeks 10. 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 Exclusion Criteria: 1. Histologically- or cytologically-confirmed Kaposi's sarcoma or GIST 2. Previous treatment with anthracyclines 3. Participation in another clinical study with an investigational product during the last 2 weeks 4. 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 5. Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or PDGFR inhibitor 6. Mean QT interval corrected for heart rate (QTc) \> 480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction 7. 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 8. 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 9. 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 10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP(investigational product). 11. History of allogenic organ transplantation. 12. Active or prior documented autoimmune or inflammatory disorders 13. Uncontrolled intercurrent illness 14. Known active infection 15. History of another primary malignancy 16. History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment 17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. 18. 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. 19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?