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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)

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ClinicalTrials.gov Identifier: NCT03147404
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : December 30, 2019
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Seung tae Kim, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma, Grade 3 Drug: Avelumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 28, 2017
Actual Primary Completion Date : July 22, 2019
Actual Study Completion Date : July 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: Avelumab
Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
Drug: Avelumab
Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
Other Name: Bavencio

Primary Outcome Measures :
  1. BEST OF RESPONSE [ Time Frame: 12months ]

Secondary Outcome Measures :
  1. OVERALL RESPONSE [ Time Frame: 24months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Be20 years of age on day of signing informed consent
  3. Have histologically or cytologically-confirmed diagnosis of GEP-NECs including all gastrointestinal tracts
  4. Have metastatic disease or locally advanced, unresectable disease with feasible biopsy sites (baseline and follow up)
  5. Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum/etoposide
  6. 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:

  1. 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.
  2. Has grade 1 or 2 neuroendocrine tumor in GI tracts.
  3. 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.
  4. Has a known history of active TB
  5. Hypersensitivity to avelumab or any of its excipients.
  6. 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.
  7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147404

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
Merck KGaA, Darmstadt, Germany
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Principal Investigator: SeungTae KIM, MD, Ph.D SamsungMedicalCenter
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Responsible Party: Seung tae Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03147404    
Other Study ID Numbers: 2017-04-085
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Antineoplastic Agents, Immunological
Antineoplastic Agents