Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

NCT06981637 | Recruiting Phase 2 DMC

• 1 other identifier: T1725
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 7

Brief Summary

Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

Conditions

Advanced Soft Tissue Sarcoma

Keywords

advanced soft tissue sarcoma; pegylated liposomal doxorubicin; open label randomized

Outcome Measures

Primary Outcomes (1)

• Progression-free survival from randomization

  The Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1, see Appendix 2) every 8 weeks, and every 12 weeks 24 weeks after randomization.

  Up to approximately 2 years

Secondary Outcomes (7)

• Overall survival (OS)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Time to next treatment (TTNT)

  Up to approximately 2 years

• Objective response rate (ORR)

  Up to approximately 2 years

• Frequency and severity of AE

  Up to approximately 2 years

Study Arms (2)

Pegylated liposomal doxorubicin

EXPERIMENTAL

Patients in experimental arm will receive pegylated liposomal doxorubicin (PLD) 40mg/m2 every 4 weeks. Maintenance PLD could be administered up to a total of 12 cycles.

Drug: Pegylated liposomal doxorubicin

Active surveillance

NO INTERVENTION

Patients in control arm will receive active surveillance without treatment (treatment holiday). In control arm, crossover is not permitted after disease progression

Interventions

Pegylated liposomal doxorubicin DRUG

pegylated liposomal doxorubicin 40mg / m2 every 4 weeks for a maximum of 12 cycles.

Also known as: Lipodox

Pegylated liposomal doxorubicin

Eligibility Criteria

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

You may qualify if:

• A histologically confirmed advanced soft tissue sarcoma. Note that subtypes typically do not use chemotherapy as standard treatment are not allowed, such as alveolar soft part sarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma)
• Patients received first-line anthracycline-based treatment for a minimum of 4 cycles and a maximum of 8 cycles.
• The best response after first-line anthracycline-based treatment must be either a complete response, partial response, or stable disease as defined by RECIST 1.1.
• The best response should be attributed solely to systemic treatment and not to local therapy. All the patients must have at least one measurable tumor based on RECIST 1.1 before initiating first-line anthracycline-based treatment.
• Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment
• Patients have a life expectancy ≥ 3 months
• Patients older than 18 years old.
• ECOG performance status of 0 to 1.
• Patients must have adequate organ function and marrow reserve measured within 7 days prior to randomization as defined below:
• Hemoglobin ≥ 9.0 g/dL;
• Absolute neutrophil count ≥ 1,500/mm3;
• Platelets ≥ 100,000/mm3;
• Total bilirubin ≤ 1.5 x upper normal limit;
• AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed;
• Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≥50ml/min;

You may not qualify if:

• Known allergy history to PLD or other drugs of liposome-based formulation.
• LVEF \< 50% at screening as determined by UCG or MUGA.
• Serious non-healing wound, ulcer, or bone fracture not related to underlying sarcoma.
• Major surgical procedure, open biopsy, significant traumatic injury, or radiotherapy within 21 days prior to randomization.
• Severe, uncontrolled medical conditions including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.
• Psychiatric illness or social situation that would preclude study compliance.
• Women with pregnant or breast feeding (a urine pregnancy test must be performed on all female patients who are of childbearing potential before entering the study, and the result must be negative.
• Another previous malignancy diagnosed within the past 3 years. Patients with carcinoma in situ and stage I malignancy under active surveillance (no medical treatment needed) are allowed for enrollment.
• Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti- convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.
• Patients with active hepatitis B. However, patients with controlled hepatitis B under anti-viral agent are allowed.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Cheng-Kung University Hospital: collaborator
• Tri-Service General Hospital: collaborator
• China Medical University Hospital: collaborator

Study Sites (7)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

NOT YET RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital,

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

liposomal doxorubicin

Study Officials

• Tsang-Wu Liu, MD

  Taiwan Cooperative Oncology Group, National Health Research Institutes

  STUDY DIRECTOR

• Tom Wei-Wu Chen, MD,PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsang-Wu Liu, MD

CONTACT

+886-2-26534401; walter@nhri.org.tw

Tom Wei-Wu Chen, MD,PhD

CONTACT

+886-2-23123456; tomweiwuchen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An investigator-initiated,A multinational open label randomized (2:1 experimental vs control) phase II study. Stratified randomization factor： 1. The response after first-line anthracycline-based treatment (CR/PR vs SD) 2. The study country. Patients will be randomized 2:1 using the method of minimization accounting for the stratification factors above.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 21, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: January 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7)