- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147404
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 (MS100070-0177)
December 26, 2019 updated by: Seung tae Kim, Samsung Medical Center
SAMSUND MEDICAL CENTER
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final contact.
After a screening phase of up to 28 days, eligible subjects will receive treatment beginning on Day 1 of each 2-week dosing cycle for aveluumab.
Treatment with aveluumab will continue until documented disease progression, unacceptable adverse event(s),intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, After the end of treatment, each subject will be followed for 30 days for adverse event monitoring (serious adverse events and events of clinical interest will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier).
Subjects who discontinue after 24months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression.
Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up.
All subjects will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Avelumab
Avelumab 10 mg/kg i.v.
every 2 weeks (Q2W)
|
Avelumab 10 mg/kg i.v.
every 2 weeks (Q2W)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BEST OF RESPONSE
Time Frame: 12months
|
12months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OVERALL RESPONSE
Time Frame: 24months
|
24months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: SeungTae KIM, MD, Ph.D, SamsungMedicalCenter
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2017
Primary Completion (Actual)
July 22, 2019
Study Completion (Actual)
July 22, 2019
Study Registration Dates
First Submitted
May 8, 2017
First Submitted That Met QC Criteria
May 8, 2017
First Posted (Actual)
May 10, 2017
Study Record Updates
Last Update Posted (Actual)
December 30, 2019
Last Update Submitted That Met QC Criteria
December 26, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-04-085
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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