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New treatment option for Soft Tissue Sarcoma
Official title Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT05679921
What this study is testing
What is pembrolizumab, pazopanib?
pembrolizumab, pazopanib is an investigational medicine, being studied as a potential treatment for soft tissue sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, randomized, phase II study to evaluate the clinical activity of pembrolizumab in combination with pazopanib compared to pazopanib monotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- Histologically confirmed Soft Tissue Sarcoma(STS) progression to 1 or 2 (less than 3) prior chemotherapy : Exclude pazopanib-resistant subtype -...
- Age \> 19 years, ≤80 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days before screening)
- Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
- Adequate normal organ and marrow function as defined below -Hemoglobin ≥9.0 g/dL -Absolute neutrophil count (ANC) ≥ 1500 per mm3 -Platelet count ≥...
You likely can't join if
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor...
- Any previous treatment with a Programmed Death-1(PD1) or Programmed Death-Ligand1(PD-L1) inhibitor, anti-PD-L2 agent, stimulatory/co-inhibitory...
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values...
- 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...
- Note: Hepatitis B and C screening tests are not required unless:
- Known history of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection
See the full eligibility criteria
- 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...
- Age \> 19 years, ≤80 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days before screening)
- Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
- 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...
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- 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...
- 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...
- 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...
- 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...
- 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
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.