Avelumab Program Rollover Study

Merck KGaA (EMD Serono)

Status and phase

Active, not recruiting

Phase 3

Conditions

Solid Tumors

Treatments

Drug: Avelumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03815643

2018-003711-21 (EudraCT Number)

2024-514274-46-00 (EU Trial (CTIS) Number)

MS100070_0176

Details and patient eligibility

About

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.

Enrollment

205 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Participant has been withdrawn from avelumab parent study for any reason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.