Avelumab in G3 NEC

NCT03278405 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-18

No results posted yet for this study

Summary

This is a single-center, single-arm, open-label, pilot trial to evaluate the efficacy and safety of avelumab in subjects with unresectable or metastatic, Grade 3, poorly-differentiated neuroendocrine.carcinoma.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

Avelumab

Avelumab will be administered intravenously as an infusion, at a dose of 10 milligram per kilogram once every 2 weeks, until occurence of progressive disease, unacceptable toxicity, or any of the other criteria for withdrawal listed in the protocol .

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY
  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Simron Singh · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-08-09
Completion
2020-03-12
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278405 on ClinicalTrials.gov