Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma

Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma: Open-label, Multicenter, Randomized, Phase 2 Trials

Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma (NCT05679921) is a Phase 2 interventional studying Soft Tissue Sarcoma, sponsored by Yonsei University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open-label, randomized, phase II study to evaluate the clinical activity of pembrolizumab in combination with pazopanib compared to pazopanib monotherapy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Soft Tissue Sarcoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 116 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Soft Tissue Sarcoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: \- 1. diagnosed by tissue sample (biopsy-confirmed) Soft Tissue Sarcoma(STS) progression to 1 or 2 (less than 3) prior chemotherapy : Exclude pazopanib-resistant subtype - embryonal rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing tumours, primitive neuroectodermal tumour, gastrointestinal stromal tumour, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma, and liposarcoma 2. Age \> 19 years, ≤80 years at time of study entry 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days before screening) 4. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 5. Adequate normal organ and marrow function as defined below -blood count (hemoglobin) at least 9.0 g/dL -Absolute neutrophil count (ANC) ≥ 1500 per mm3 -Platelet count ≥ 100,000 per mm3 -Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). -Aspartate Aminotransferase (AST, SGOT)/Alanine Aminotransferase (ALT, SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN -Creatinine≤1.5 x ULN -International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) : ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants 6. The participant (or legally acceptable representative if applicable) provides written willing to sign a consent form for the trial. 7. A male or female participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: \- 1. Histologically confirmed Soft Tissue Sarcoma(STS) progression to 1 or 2 (less than 3) prior chemotherapy : Exclude pazopanib-resistant subtype - embryonal rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing tumours, primitive neuroectodermal tumour, gastrointestinal stromal tumour, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma, and liposarcoma 2. Age \> 19 years, ≤80 years at time of study entry 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days before screening) 4. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 5. Adequate normal organ and marrow function as defined below -Hemoglobin ≥9.0 g/dL -Absolute neutrophil count (ANC) ≥ 1500 per mm3 -Platelet count ≥ 100,000 per mm3 -Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). -Aspartate Aminotransferase (AST, SGOT)/Alanine Aminotransferase (ALT, SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN -Creatinine≤1.5 x ULN -International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) : ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants 6. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 7. A male or female participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days after the last dose of study treatment. 9. Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Exclusion Criteria: 1. 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 2. Any previous treatment with a Programmed Death-1(PD1) or Programmed Death-Ligand1(PD-L1) inhibitor, anti-PD-L2 agent, stimulatory/co-inhibitory T-cell receptor (eg. CTLA-4, OX-40, CD137), and/or pazopanib 3. 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 4. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Investigational Product(IP). 6\. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 7\. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-Central Nervous System(CNS) disease. 8\. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 9\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 10\. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, urothelial cancer, or carcinoma in situ that have undergone potentially curative therapy are not excluded. 11\. Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable: without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention). 12\. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. 13\. Has a history of or current(non-infectious) pneumonitis/interstitial lung disease that required steroids 14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority. 15. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. * Note: Hepatitis B and C screening tests are not required unless: * Known history of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection * As mandated by local health authority 16. Known active infection requiring systemic therapy. * Active infection including tuberculosis * Active hepatitis B (HBsAg reactive and HBV DNA is detected) * Active hepatitis C (anti-HCV reactive and HCV RNA \[qualitative\] is detected) * Human immunodeficiency virus infection 17. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. 18\. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 19\. Has had an allogenic tissue/solid organ transplant. 20. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. 21\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 22\. Known or probable QT interval prolongation. 23. Any following history in past 6 months * Coronary angioplasty or stent insertion, myocardial infarction, unstable angina, coronary artery bypass, New York Heart Association(NYHA) stage III or IV congestive heart failure, thromboembolism (stable patients on anticoagulation for at least 6 weeks can be enrolled), hemoptysis, brain hemorrhage or clinically significant gastrointestinal bleeding.

Treatments Being Tested

DRUG

pembrolizumab, pazopanib

Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing. Participants who complete study intervention after 2 years of pembrolizumab can be treated with pazopanib monotherapy based on physician's judgement. The duration of optional pembrolizumab crossover treatment will be maximum of 2 years i.e. a total of 35 cycles of pembrolizumab for patients progressing on pazopanib.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Severance Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05679921), the sponsor (Yonsei University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05679921 clinical trial studying?

This is an open-label, randomized, phase II study to evaluate the clinical activity of pembrolizumab in combination with pazopanib compared to pazopanib monotherapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05679921?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05679921?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05679921. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05679921. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.