Solid Tumors
Conditions
Keywords
Avelumab, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Urothelial carcinoma (UC), Ovarian cancer
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.
Interventions
DRUGAvelumab
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).
Sponsors
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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ingredients * Participant has been enrolled in the comparator arm of avelumab parent study * Participant has been withdrawn from avelumab parent study for any reason * Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Responsible
Merck KGaA, Darmstadt, Germany
Outcome results
None listed