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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03815643Tipo: INTERVENTIONALInicio: 22 de mar de 2019Fin estimado: 19 de feb de 2027

Oncología Neumología Nefrología Obstetricia y Ginecología Urología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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Participant has been withdrawn from avelumab parent study for any reason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

Intervenciones

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).

Ubicaciones

Instituto Alexander Fleming

Ciudad Autonoma Buenos Aires, Argentina

Clínica Universitaria Privada Reina Fabiola

Córdoba, Argentina

Patrocinadores

PrincipalEMD Serono Research & Development Institute, Inc.

ColaboradorMerck KGaA, Darmstadt, Germany

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