Solid Tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of Merck KGaA - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 103 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 209
Exclusion criteria
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ingredients - Participant has been enrolled in the comparator arm of avelumab parent study - Participant has been withdrawn from avelumab parent study for any reason - Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: - To evaluate the overall survival (OS) (for NSCLC, RCC, UC, and ovarian cancer indications only) - To evaluate the progression free survival (PFS) - To evaluate duration of response (DR);Primary end point(s): Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study;Timepoint(s) of evaluation of this end point: From enrolment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Number of Participants with Overall Survival (OS) 2 Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) 3 Duration of Response (DR) Assessed from Complete Response (CR) or Partial Response (PR) ;Timepoint(s) of evaluation of this end point: 1 From baseline (parent study) up to 5 years 2 From baseline (parent study) up to 5 years 3 From baseline (parent study) up to 5 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Czechia, Czech Republic, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed