Avelumab Program Rollover Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: Avelumab


Participation Criteria
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Eligibility Criteria
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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ingredients Participant has been enrolled in the comparator arm of avelumab parent study Participant has been withdrawn from avelumab parent study for any reason Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avelumab<br> | Drug: Avelumab<br>* 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).<br>* Other names: MSB0010718C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From baseline up to 5 years | 
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |  | From baseline up to 5 years | 
| Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) |  | From baseline up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avelumab, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Urothelial carcinoma (UC), Ovarian cancer