A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Me… (NCT03069378) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma
United States41 participantsStarted 2017-03-03
Plain-language summary
The purpose of this study is to determine how well the combination of therapy of talimogene laherparepvec (T-VEC) and pembrolizumab works in the treatment of patients with sarcoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female age ≥ 18 years at the time of informed consent
* Be willing and able to provide written informed consent/assent for the trial
* Be willing to comply with treatment protocol
* Subjects must have a histologically confirmed metastatic and/or locally advanced inoperable sarcoma (metastatic/locally advanced cohort)
* For histology specific additional metastatic cohorts, patients must have undifferentiated pleomorphic sarcoma/myxofibrosarcoma, epithelioid sarcoma or cutaneous angiosarcoma.
* Subjects must have at least 1 injectable cutaneous, subcutaneous (superficial or deep) soft tissue or nodal lesion ≥ 10 mm in longest diameter. Of note, bone lesions are not eligible for injection unless there is a soft tissue component that is amenable to injection. Injectable 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
* Subjects with locally advanced/metastatic sarcoma must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy). An exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., epithelioid sarcoma). Treatment naive patients may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count provided it was completed m…