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Monoclonal Antibodies

Intervention Arm for Neuroendocrine Carcinoma (NET-001 Trial)

Phase 1 & 2
Waitlist Available
Led By Simron Singh
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

NET-001 Trial 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.

Eligible Conditions
  • Neuroendocrine Carcinoma

NET-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
DCR by irRECIST version 1.1
Disease control rate (DCR)
Duration of response
+10 more
Other outcome measures
Correlation of PD-L1 status with response to avelumab
Correlation of mutational load and T-cell repertoire analysis with response to avelumab

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Investigations
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Infections and infestations
6%
Nervous system disorders
6%
Immune system disorders
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

NET-001 Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Treatment with avelumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
661 Previous Clinical Trials
1,554,041 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
439 Previous Clinical Trials
114,905 Total Patients Enrolled
Simron SinghPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
117 Total Patients Enrolled
~1 spots leftby Jun 2025
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