Avelumab Program Rollover Study

• ClinicalTrials.gov Identifier: NCT03815643
• Recruitment Status: Active, not recruiting
• First Posted: January 24, 2019
• Last Update Posted: March 23, 2022
• 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

• First Submitted Date: January 22, 2019
• First Posted Date: January 24, 2019
• Last Update Posted Date: March 23, 2022
• Actual Study Start Date: March 22, 2019
• Estimated Primary Completion Date: January 28, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Avelumab Program Rollover Study
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors

Intervention

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

Experimental: Avelumab

Intervention: Drug: Avelumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 20, 2020): 161
• Original Estimated Enrollment (submitted: January 22, 2019): 264
• Estimated Study Completion Date: January 28, 2024
• Estimated Primary Completion Date: January 28, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Belgium, Brazil, Japan, Korea, Republic of, Romania, Russian Federation, United States
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT03815643
• Other Study ID Numbers: 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

• 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: EMD Serono Research & Development Institute, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible; Merck KGaA, Darmstadt, Germany

• PRS Account: EMD Serono
• Verification Date: March 2022