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

NCT03802071 | Completed Phase 1

• 1 other identifier: 4-2018-0746
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• adverse event

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

  3 weeks

Study Arms (1)

Durvalumab+doxorubicin combination

EXPERIMENTAL

Drug: Durvalumab+doxorubicin cobination

Interventions

Durvalumab+doxorubicin cobination DRUG

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

Durvalumab+doxorubicin combination

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 14, 2019
• Study Start: September 16, 2019
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

KR (1)