drugset / Trial / NCT03116529
Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma
Phase 1/2
Terminated
22 enrolled
University of Maryland, Baltimore
AstraZeneca · collabUniversity of Arizona · collabWest Penn Allegheny Health System · collab
NaSingle-groupOpen-labelTreatment
Summary
Chemotherapy is controversial for soft tissue sarcoma that has not yet metastasized. Surgery and radiation are effective for local control, but there are no highly effective interventions to prevent metastatic spread of soft tissue sarcoma. Immunotherapy has shown promise in other types of cancer. Combining two types of immunotherapy agents with preoperative radiation may help the immune system recognize the sarcoma and stimulate an anti-tumor immune response.
Timeline
- Start
- 2017-06-21
- Primary completion
- 2024-06-21
- Completion
- 2024-06-21
Publications
- Ng VY, Sahlani MN, Fogel JD, Chiu AK, Kallen ME, Davis D, Snider J, Regine W, Bentzen SM, Sausville E. Results of an Integrated Phase I/II Prospective Clinical Trial (NEXIS) for Neoadjuvant Anti-PD-L1 (Durvalumab) and Anti-CTLA-4 (Tremelimumab) With Radiation for High-Risk Soft-Tissue Sarcoma of the Trunk and Extremities. Cureus. 2024 Oct 22;16(10):e72119. doi: 10.7759/cureus.72119. eCollection 2024 Oct.
- Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |