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 range18 Years
SexALL
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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…