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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroendocrine Carcinoma, Grade 3 | Drug: Avelumab | Phase 2 |
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 |
Official Title: | SAMSUND MEDICAL CENTER |
Actual Study Start Date : | December 28, 2017 |
Actual Primary Completion Date : | July 22, 2019 |
Actual Study Completion Date : | July 22, 2019 |

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 |
- BEST OF RESPONSE [ Time Frame: 12months ]
- OVERALL RESPONSE [ Time Frame: 24months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 06351 |
Principal Investigator: | SeungTae KIM, MD, Ph.D | SamsungMedicalCenter |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Neuroendocrine Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Avelumab Antineoplastic Agents, Immunological Antineoplastic Agents |