Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma (NEXIS)
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|ClinicalTrials.gov Identifier: NCT03116529|
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Combination Product: Combination Radiation, Immunotherapy, Surgery||Phase 1 Phase 2|
The main purposes of this study are to evaluate the safety, tolerability, and efficacy of Durvalumab and Tremelimumab in combination with radiation prior to surgical resection of high-risk soft tissue sarcoma in the pelvis and extremities.
Patients will receive the same radiation therapy and surgical care they would receive normally and with no change in timing or duration of each treatment. They will also receive two immunotherapy agents, Durvalumab and Tremelimumab, during radiation prior to surgery, and a single agent, Durvalumab, after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Anti-PD-L1 (Durvalumab/MEDI4736) Plus Anti-CTLA-4 (Tremelimumab) and Radiation for High Risk Soft-Tissue Sarcoma|
|Actual Study Start Date :||June 21, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2022|
Neoadjuvant Radiation plus Durvalumab and Tremelimumab Wide Surgical Resection Adjuvant Durvalumab
Combination Product: Combination Radiation, Immunotherapy, Surgery
Three doses of Durvalumab (1500 mg) and Tremelimumab (75 mg) given intravenously once every four weeks during radiotherapy prior to surgery.
Radiation therapy delivered with a minimum dose of 50 Gy and 1.8-2 Gy per fraction. Bulky sarcomas, defined as >10 cms in greatest dimension, receive a single 15 Gy fraction of high-dose spatially fractionated (GRID) radiation therapy within 1-3 days prior to radiation therapy
Surgical resection is performed at least 5-8 weeks after cessation of radiotherapy and 4 weeks after completion of neoadjuvant immunotherapy.
Patients with no evidence of disease following surgical resection receive four additional doses and patients with evidence of disease receive nine additional doses of Durvalumab (1500 mg IV) once every four weeks unless there is clear progression of disease.
- Toxicity: Number of subjects experiencing high-grade toxicity [ Time Frame: 90 days after receipt of final dose of Durvalumab monotherapy or 180 days after receipt of final dose of combination Durvalumab/Tremelimumab, whichever is longer ]Number of subjects experiencing high-grade toxicity
- Histopathologic Response [ Time Frame: At time of surgery ]Number of subjects with an excellent response on histopathologic examination of the surgically removed tumor
- Overall Survival Rate [ Time Frame: Two years after start of treatment ]Percentage of patients still alive
- Overall Survival Rate [ Time Frame: Five years after start of treatment ]Percentage of patients still alive
- Disease-Specific Survival Rate [ Time Frame: Two years after start of treatment ]Percentage of patients who have not died from soft tissue sarcoma
- Disease-Specific Survival Rate [ Time Frame: Five years after start of treatment ]Percentage of patients who have not died from soft tissue sarcoma
- Relapse-Free Survival Rate [ Time Frame: Two years after start of treatment ]Percentage of patients who have not had a documented relapse of local or distant disease
- Relapse-Free Survival Rate [ Time Frame: Five years after start of treatment ]Percentage of patients who have not had a documented relapse of local or distant disease
- Radiologic Response To Treatment [ Time Frame: At time of surgery ]Best overall response to Neoadjuvant Radiation and Immunotherapy using Response Evaluation Criteria in Solid Tumors (RECIST)
- Radiologic Response To Treatment [ Time Frame: At time of surgery ]Best overall response to Neoadjuvant Radiation and Immunotherapy using immune-related response criteria (irRC)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116529
|Contact: Study Coordinator||410-328-6465||Navid.Saeidi@umm.edu|
|Contact: Vincent Y. Ng, MDfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland Medical Center, Greenebaum Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Navid Saeidi 410-328-6465 Navid.Saeidi@umm.edu|
|Sub-Investigator: Ed Sausville, MD|
|Sub-Investigator: William Regine, MD|
|Sub-Investigator: Daniel Lerman, MD|
|Sub-Investigator: Paul Staats, MD|
|Sub-Investigator: Eduardo Davila, PhD|
|Principal Investigator:||Vincent Y. Ng, MD||University of Maryland Medical Center, Greenebaum Comprehensive Cancer Center|