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Advanced Soft Tissue SarcomaPhase 2MELODYNCT06981637

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

A Phase 2 study testing Pegylated liposomal doxorubicin in people with Advanced Soft Tissue Sarcoma, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Soft Tissue Sarcoma
What is being tested?
Pegylated liposomal doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
7 sitesTaiwan
Study dates
31 Dec 2025to 31 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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
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  • 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;
  • All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
  • Patients with reproductive potential must use effective contraception (hormone orbarrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.
  • Patients must be able to comply with study procedures and sign informed consent.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hui-Jen Tsai, MD contact

+886-6-7000123 ext. 65149

hjtsai@nhri.edu.tw

Tom Wei-Wu Chen, MD,PhD contact

+886-2-23123456 ext. 267462

tomweiwuchen@ntu.edu.tw

7 sites in 1 country

Taiwan7 sites, 7 recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City

    Yu-Li Su, MD

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital,

    Kaohsiung City

    Yi-Chang Liu, MD

    Recruiting

  • China Medical University Hospital

    Taichung

    Li-Yaun Bai, M.D.PhD

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Chia-Jui Yen, MD,PhD

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Tom Wei-Wu Chen, MD,PhD, tomweiwuchen@ntu.edu.tw

    Recruiting

  • Taipei Veterans General Hospital

    Taipei

    Chueh-Chuan Yen, MD,PhD

    Recruiting

  • Tri-Service General Hospital

    Taipei

    Ming-Shen Dai, MD

    Recruiting

Other trials in Taiwan

About this study

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

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

Read the detailed description

Patients enrolled will be randomized to either experimental arm or control arm. 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. Patients in control arm will receive active surveillance without treatment (treatment holiday).

Being tested
Pegylated liposomal doxorubicin
Keywords
advanced soft tissue sarcoma, pegylated liposomal doxorubicin, open label randomized

What participants receive

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

  • Pegylated liposomal doxorubicinDrug

    Also called Lipodox

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

Study groups in NCT06981637
Study groupRoleWhat they receive
Pegylated liposomal doxorubicinExperimentalPatients 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.
Receives: Drug: Pegylated liposomal doxorubicin
Active surveillanceNo interventionPatients in control arm will receive active surveillance without treatment (treatment holiday). In control arm, crossover is not permitted after disease progression

What is being measured

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

  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.

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Overall survival (OS)

    Defined as the time from the date of randomization to the date of death from any cause, or censoring at the date of last known follow-up alive

    Measured: Up to approximately 2 years

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) rate at 12 months. PFS is defined as the time from the date of randomization to the date of first documented evidence of progressive disease (including radiograph or clinical progressive disease), or death, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Time to next treatment (TTNT)

    Defined as the time from the date of randomization to the date of commencing next treatment line. Patients who started other anti-cancer therapy (including radiotherapy and surgery) will be counted as an event for TTNT. Those who received radiotherapy or surgical resection after randomization but not based on clinical or radiological progression are considered as an event for TTNT.

    Measured: Up to approximately 2 years

  4. Objective response rate (ORR)

    Objective response rate (ORR) at maintenance PLD phase per RECIST 1.1 criteria

    Measured: Up to approximately 2 years

  5. Frequency and severity of AE

    AEs will be accessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

    Measured: Up to approximately 2 years

  6. Safety of interest: cardiac function as assessed by LVEF

    Safety of interest: cardiac function as assessed by LVEF(either by cardiac US or MUGA)

    Measured: Up to approximately 2 years

  7. Quality of Life Effects on patient-reported outcomes as assessed by EORTC QLQ C30

    The questionnaire comprises 5 functioning scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. The functioning and symptoms items are scored on a 4-point scale that range from "not at all" to "very much," and the global health status and QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent.". There are 30 questions in total and the scores range from 0 to 100.

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted21 May 2025
  2. Study start31 Dec 2025
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2029 (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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06981637
Sponsor's protocol ID
T1725
Acronym
MELODY
Status last verified
Nov 2025
First submitted
5 May 2025
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated liposomal doxorubicin in people with Advanced Soft Tissue Sarcoma, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.

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 19 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Taiwan. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hui-Jen Tsai, MD (+886-6-7000123 ext. 65149, hjtsai@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival from randomization (time frame: Up to approximately 2 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 NCT06981637.

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 2 Jul 2026.

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