Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin

Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Study ID
NCT03095274
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab, 1500 mg Q4W for 12 months.
  • Tremelimumab — DRUG
    Tremelimumab 75 mg Q4W for up to 4 doses/cycles.

Study Details

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.

Key Dates

Start date
Apr 11, 2017
Status verified
Nov 2024
Primary completion
Nov 30, 2019
Completion
May 23, 2022

Study Design

Enrollment
126 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) for 12 months in patients ≥ 30kg. Weight-based dosing should be used for patients \<30 kg: durvalumab 20 mg/kg.
  • Experimental: Tremelimumab
    Tremelimumab 75 mg Q4W (equivalent to 1 mg/kg Q4W) for up to 4 doses/cycles in patients ≥ 30kg. Weight-based dosing should be used for patients \<30 kg: tremelimumab 1 mg/kg Q4.

Primary Outcome Measure

Clinical Benefit Rate (CBR) [ Time Frame: 9 months ]

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