EUCTR2018-001360-39-IT
Active, not recruiting
Phase 1
A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab with Radiotherapy and Adjuvant Pembrolizumab in Patients with High-Risk, Localized Soft Tissue Sarcoma of the Extremity - SU2C-SARC032
ConditionsThis trial investigates whether neoadjuvant radiotherapy combined with pembrolizumab followed by surgical resection and adjuvant pembrolizumab improves disease-free survival for patients with high-risk soft tissue sarcoma of the extremity (undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma, tumor size > 5 cm, grade 2 or 3 out of 3) compared to radiotherapy alone followed by surgical resectionMedDRA version: 20.0Level: PTClassification code 10024629Term: Liposarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- This trial investigates whether neoadjuvant radiotherapy combined with pembrolizumab followed by surgical resection and adjuvant pembrolizumab improves disease-free survival for patients with high-risk soft tissue sarcoma of the extremity (undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma, tumor size > 5 cm, grade 2 or 3 out of 3) compared to radiotherapy alone followed by surgical resection
- Sponsor
- SARC
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1Age equal to or higher than 12 years
- •2Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e. shoulder or hip) that measures greater than 5 cm in any direction as assessed by imaging; Alternative terms for UPS meeting inclusion criteria include but are not limited to the following
- •pleomorphic undifferentiated sarcoma
- •unclassified spindle cell sarcoma
- •spindle cell sarcoma not otherwise specified
- •pleomorphic spindle cell sarcoma
- •pleomorphic fibroblastic sarcoma
- •undifferentiated high\-grade pleomorphic sarcoma
- •pleomorphic sarcoma with prominent inflammation
- •pleomorphic sarcoma with giant cells
Exclusion Criteria
- •1Prior chemotherapy, targeted small molecule therapy, or radiation therapy for current diagnosis of sarcoma
- •2Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
- •3Concurrent, clinically significant, active malignancies within two years of study enrollment.
- •4Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
- •5Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- •6Major surgery within four weeks prior to Day 1 of study or who have not recovered adequately from prior surgery.
- •7Currently receiving a study therapy or if they had an investigational agent within 4 weeks at the time of enrollment.
- •8Women who are pregnant or nursing/breastfeeding, or expecting to conceive or men who are expecting to father children within the projected duration of the trial, starting with the pre\-screening or screening visit through 120 days after the last dose of pembrolizumab.
- •9Inability to comply with protocol required procedures
- •10Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy by oral or IV routes within 7 days prior to the first dose of trial treatment
Outcomes
Primary Outcomes
Not specified
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