Neuroendocrine Carcinoma, Grade 3Phase 2MS100070-0177NCT03147404
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
A Phase 2 study testing Avelumab in people with Neuroendocrine Carcinoma, Grade 3, run by Samsung Medical Center at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuroendocrine Carcinoma, Grade 3
- What is being tested?
- Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2017to 22 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Neuroendocrine Carcinoma, Grade 3
- Being tested
- Avelumab
- Medical subject headings
- Carcinoma, Neuroendocrine, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called Bavencio
Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
| Study group | Role | What they receive |
|---|---|---|
| Avelumab | Experimental | Avelumab 10 mg/kg i.v. every 2 weeks (Q2W) Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
BEST OF RESPONSE
Measured: 12months
Secondary outcomes (1)
OVERALL RESPONSE
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start28 Dec 2017
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Carcinoma, Grade 3Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Principal investigator, Seung tae Kim, Samsung Medical Center
- Investigators
- SeungTae KIM, MD, Ph.D, Principal investigator, SamsungMedicalCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147404
- Sponsor's protocol ID
- 2017-04-085
- Acronym
- MS100070-0177
- Status last verified
- Dec 2019
- First submitted
- 8 May 2017
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAMSUND MEDICAL CENTER
- ClinicalTrials.gov ID
- NCT03147404
- Acronym / sponsor ID
- MS100070-0177 / 2017-04-085
- Conditions
- Neuroendocrine Carcinoma, Grade 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
| Arm | Type | Receives |
|---|---|---|
| Avelumab | Experimental | Drug: AvelumabAvelumab 10 mg/kg i.v. every 2 weeks (Q2W) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAlso: BavencioAvelumab 10 mg/kg i.v. every 2 weeks (Q2W) | Drug | Avelumab |
Primary outcome
BEST OF RESPONSE
Time frame: 12months
1 secondary outcome
OVERALL RESPONSE
Time frame: 24months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
Related trials for Neuroendocrine Carcinoma, Grade 3
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Active, not recruitingPhase 1
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.
Thyroid Cancer, Medullary, Neuroendocrine Tumor of the Lung Grade 1 and 2
RecruitingPhase 1
SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
Neuroendocrine Carcinoma, Neuroendocrine Tumors
Active, not recruitingPhase 1/2
A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)
Small-Cell Lung Cancer, Neuroendocrine Carcinoma
RecruitingPhase 1
FTT PET/CT in Pancreatic Neuroendocrine Tumors
Neuroendocrine Carcinoma Metastatic, Pancreatic Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SeungTae KIM, MD, Ph.D principal investigator
SamsungMedicalCenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab in people with Neuroendocrine Carcinoma, Grade 3, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BEST OF RESPONSE (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.