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Avelumab Program Rollover Study

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 : June 16, 2022
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date June 16, 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
 (submitted: January 22, 2019)
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
 (submitted: January 22, 2019)
  • Overall Survival (OS) [ Time Frame: From baseline up to 5 years ]
  • Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From baseline up to 5 years ]
  • Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) [ Time Frame: From baseline up to 5 years ]
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
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
Study Arms  ICMJE Experimental: Avelumab
Intervention: Drug: Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2020)
161
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2019)
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:

  • Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany

    • Merck Serono Co., Ltd (Japan)
  • Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
  • Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
  • Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

  • Participants who are pregnant or breastfeeding
  • Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
  • Participant has been enrolled in the comparator arm of avelumab parent study
  • Participant has been withdrawn from avelumab parent study for any reason
  • Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
  • Other protocol defined exclusion criteria could apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
URL: http://bit.ly/IPD21
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
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP