Avelumab Program Rollover Study

Overview

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.

Full Title of Study: “An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 28, 2024

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: Avelumab

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMD Serono Research & Development Institute, Inc.
  • Collaborator
    • Merck KGaA, Darmstadt, Germany
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Responsible, Study Director, Merck KGaA, Darmstadt, Germany
  • Overall Contact(s)
    • Communication Center, +49 6151 72 5200, service@emdgroup.com

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