Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

Recruiting Phase 2 Phase 3 Interventional Study
Advanced Extrapulmonary Neuroendocrine Carcinoma Metastatic Extrapulmonary Neuroendocrine Carcinoma Recurrent Extrapulmonary Neuroendocrine Carcinoma Unresectable Extrapulmonary Neuroendocrine Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
189 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
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About This Trial
This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph node…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC) * Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as…
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