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Brief Title: Avelumab Program Rollover Study

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

INTRODUCTION

  • Org Study ID: MS100070_0176
  • Secondary ID: N/A
  • NCT ID: NCT03815643
  • Sponsor: EMD Serono Research & Development Institute, Inc.

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    March 22, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs)

Primary Outcome 1 - Timeframe: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)

Primary Outcome 2 - Measure: All Serious AEs

Primary Outcome 2 - Timeframe: N/A

Primary Outcome 3 - Measure: Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events

Primary Outcome 3 - Timeframe: N/A

CONDITION

  • Solid Tumors

ELIGIBILITY

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- * Participant has been withdrawn from avelumab parent study for any reason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: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Responsible

Role: Study Director

Affiliation: Merck KGaA, Darmstadt, Germany

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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