Trial record 1 of 1 for:
MS100070_0176
Avelumab Program Rollover Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03815643 |
Recruitment Status :
Active, not recruiting
First Posted : January 24, 2019
Last Update Posted : March 23, 2022
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Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | January 22, 2019 | ||||||||||||||||||
First Posted Date ICMJE | January 24, 2019 | ||||||||||||||||||
Last Update Posted Date | March 23, 2022 | ||||||||||||||||||
Actual Study Start Date ICMJE | March 22, 2019 | ||||||||||||||||||
Estimated Primary Completion Date | January 28, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events [ Time Frame: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab) ] | ||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Avelumab Program Rollover Study | ||||||||||||||||||
Official Title ICMJE | An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies | ||||||||||||||||||
Brief Summary | The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study. | ||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumors | ||||||||||||||||||
Intervention ICMJE | Drug: Avelumab
Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).
Other Name: MSB0010718C
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Study Arms ICMJE | Experimental: Avelumab
Intervention: Drug: Avelumab
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||
Actual Enrollment ICMJE |
161 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
264 | ||||||||||||||||||
Estimated Study Completion Date ICMJE | January 28, 2024 | ||||||||||||||||||
Estimated Primary Completion Date | January 28, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Argentina, Belgium, Brazil, Japan, Korea, Republic of, Romania, Russian Federation, United States | ||||||||||||||||||
Removed Location Countries | Germany | ||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03815643 | ||||||||||||||||||
Other Study ID Numbers ICMJE | MS100070_0176 2018-003711-21 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | EMD Serono ( EMD Serono Research & Development Institute, Inc. ) | ||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||
Current Study Sponsor ICMJE | EMD Serono Research & Development Institute, Inc. | ||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||
Collaborators ICMJE | Merck KGaA, Darmstadt, Germany | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | EMD Serono | ||||||||||||||||||
Verification Date | March 2022 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |