Phase II Study of Avelumab in Metastatic Gastronetro-pancreatic （GEP） Neuroendocrine Carcinoma （NEC, WHO Grade 3） as Second-line Treatment After Failing to Etoposide+Cisplatin: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes

NCT03147404 | Completed Phase 2

• 1 other identifier: 2017-04-085
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II study of avelumab in metastatic gastronetro-pancreatic (GEP) neuroendocrine carcinoma (NEC, WHO grade 3) as second-line treatment after failing to etoposide+cisplatin: integration of genomic analysis to identify predictive molecular subtypes

Conditions

Neuroendocrine Carcinoma, Grade 3

Outcome Measures

Primary Outcomes (1)

• BEST OF RESPONSE

  12months

Secondary Outcomes (1)

• OVERALL RESPONSE

  24months

Study Arms (1)

Avelumab

EXPERIMENTAL

Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)

Drug: Avelumab

Interventions

Avelumab DRUG

Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)

Also known as: Bavencio

Avelumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent for Biomedical Research. However, the subject may participate in the main trial without participating in Biomedical Research.
• Be20 years of age on day of signing informed consent
• Have histologically or cytologically-confirmed diagnosis of GEP-NECs including all gastrointestinal tracts
• Have metastatic disease or locally advanced, unresectable disease with feasible biopsy sites (baseline and follow up)
• Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum/etoposide
• Have measurable disease based on mRECIST as determined by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Has grade 1 or 2 neuroendocrine tumor in GI tracts.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has a known history of active TB
• Hypersensitivity to avelumab or any of its excipients.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Lymphoma, Follicular

Interventions

avelumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• SeungTae KIM, MD, Ph.D

  SamsungMedicalCenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Model Details: Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: December 28, 2017
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

KR (1)