Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin
NCT03095274 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2025-01-09
Summary
Well-differentiated gastroenteropancreatic and lung neuroendocrine tumors are generally malignancies with a prolonged natural history. However, clinical behavior is heterogeneous and when tumor progression is observed, treatment options are limited. The most used therapy for neuroendocrine tumors management are somatostatin analogs. However, even the use in lung carcinoids is quite usual, no antitumoral activity has been demonstrated. Tremelimumab and Durvalumab combination could be more efficient drugs to improve immune system activation and could obtain a significantly higher clinical benefit in these patients. Tremelimumab and Durvalumab would be the first immune combination agents showing efficacy in neuroendocrine neoplasms of different origins.
Conditions
- Neuroendocrine Tumors
- Neuroendocrine Neoplasm of Lung
Interventions
- DRUG
-
Durvalumab, 1500 mg Q4W for 12 months.
- DRUG
-
Tremelimumab
Tremelimumab 75 mg Q4W for up to 4 doses/cycles.
Sponsors & Collaborators
-
Grupo Espanol de Tumores Neuroendocrinos
lead OTHER
Principal Investigators
-
Jaume Capdevila, M.D., Ph.D. · Hospital Universitari Vall d'Hebron, Barcelona
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-11
- Primary Completion
- 2019-11-30
- Completion
- 2022-05-23
Countries
- Spain
Study Locations
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