CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Durvalumab +1 moredrug
Likely dose
Durvalumab 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03095274
NCT03095274Phase 2Completed

A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for the Treatment of Patients With Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin (the DUNE Trial)

Grupo Espanol de Tumores Neuroendocrinos·interventional·Posted Mar 29, 2017·Updated Jan 9, 2025

In Brief

A Phase 2 clinical trial evaluating Durvalumab and Tremelimumab for Neuroendocrine Tumors and Neuroendocrine Neoplasm of Lung. Completed, enrolled 126 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartApr 11, 2017
Primary CompletionNov 30, 2019
Study CompletionMay 23, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.3 years ago

Interventions

Durvalumabdrug

Durvalumab, 1500 mg Q4W for 12 months.

Tremelimumabdrug

Tremelimumab 75 mg Q4W for up to 4 doses/cycles.