Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma (NCT04784247) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma
United States52 participantsStarted 2021-03-18
Plain-language summary
The purpose of this study is to find out whether combining the study drugs, lenvatinib and pembrolizumab, is a safe and effective treatment for metastatic soft tissue sarcomas that cannot be removed with surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female age ≥18 years at time of informed consent
* Be willing and able to provide written informed consent/assent for the trial
* Be willing to comply with treatment protocol
* Availability of archival tissue for correlative studies; either a paraffin block or at least 20 unstained slides are acceptable
* Patients must have a metastatic and/or unresectable soft tissue sarcoma as below:
* Cohort A: Leiomyosarcoma
* Cohort B: High grade undifferentiated pleomorphic sarcoma
* Cohort C: Vascular sarcomas (including angiosarcoma and epithelioid hemangioendothelioma)
* Cohort D: Other soft tissue sarcomas (including synovial sarcoma and malignant peripheral nerve sheath tumor
* Cohort E: Bone sarcomas (including osteosarcoma and chondrosarcoma)
* Subjects must have had at least 1 but not more than 3 prior lines of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy); patients who decline the standard of care first-line systemic therapy will be eligible for this trial. Prior adjuvant therapy will not count provided it was completed more than 6-month previously.
* Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.Where and when possible, target lesions will not be chosen as the biopsy lesion.
* Must have a performance statu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.