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Protocol No.1711GCCCPrincipal InvestigatorNg, Vincent
PhasePhase I/II (Cancer Control)
Age GroupAdult
TitleNeoadjuvant Anti-PD-L1 (Durvalumab/MEDI4736) Plus Anti-CTLA-4 (Tremelimumab) and Radiation for High Risk Soft-Tissue Sarcoma
DescriptionThe purpose of the study is to test the combination of two drugs called Durvalumab and Tremelimumab with radiation. Both drugs are designed to strengthen your immune system to potentially recognize the tumor and kill tumor cells. Using your immune system to potentially recognize and kill tumor cells is known as immunotherapy. You will still receive the standard of care treatment for soft tissue sarcoma, namely radiation plus surgery, but you will have immunotherapy added to your treatment.
TreatmentA. Chemotherapy Drugs: Tremelimumab Durvalumab (DURVA) B. Radiation Therapy C. Surgery
Key Eligibility1.Written informed consent and any locally-required authorization (e.g., HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
2. Patients with a biopsy-proven adult-type high-risk soft tissue sarcoma (STS) in the trunk (non-retroperitoneal) or extremities. Histologies will include the most common adult-type STS such as undifferentiated pleomorphic sarcoma, liposarcoma, leiomyosarcoma, fibrosarcoma, synovial sarcoma, angiosarcoma, epithelioid sarcoma and malignant peripheral nerve sheath tumor. STS considered high-risk as defined below:
-Tumors greater than or equal to 5 cm, intermediate or high grade according to FNCLCC criteria, and a location deep to fascia.
-Intermediate or high-grade tumors that are locally recurrent, metastatic or have had prior inadequate resections
-Intermediate and High Grade Tumors shall be Grade 2 or 3 based on FNCLCC parameters (Trojani et al, 1984; Coindre 2006)
o Tumor Differentiation
-Score 1 (sarcomas closely resembling normal adult mesenchymal tissue)
-Score 2 (sarcomas for which histological typing is certain)
-Score 3 (embryonal and undifferentiated sarcomas)
o Mitotic Count (HPF – high power field – 0.17 mm squared)
-Score 1 (0-9 mitoses per 10 HPF)
-Score 2 (10-19 mitoses per 10 HPF)
-Score 3 (greater than or equal to 20 mitoses per 10 HPF)
o Tumor Necrosis
-Score 0 (no necrosis)
-Score 1 (less than 50% tumor necrosis)
-Score 2 (greater than or equal to 50% tumor necrosis)
o Histological Grade
-Grade 1 – total score 2 or 3
-Grade 2 – total score 4 or 5
-Grade 3 – total score 6, 7 or 8
3. Patients must have measurable disease as defined by RECIST v1.1.
4. Age > 18 years at time of study entry
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
6. Life expectancy of > 12 weeks based on investigator estimate
7. Adequate normal organ and marrow function
8. Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: > or equal to 60 years old and no menses for > or equal to 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
9. Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized male subjects who are sexually active with a female partner of childbearing potential must be willing to use 2 methods of effective contraception (Table 1) from time of screening through 180 days after receipt of the final dose of Durvalumab + Tremelimumab combination therapy or 90 days after receipt of the final dose of Durvalumab Monotherapy, whichever is the longer time period.
10. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Applicable Disease SitesSoft Tissue
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03116529
ContactGreenebaum Cancer Center Navid Saeidi, MS Phone:410-328-6465
Pager:410-328-2337 #7678
Email:Navid.saeidi@umm.edu
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