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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | March 22, 2019 | Phase 3 | Interventional |
Primary Outcome 1 - Measure: 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
Primary Outcome 1 - Time Frame: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
Criteria:
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- Participant has been withdrawn from avelumab parent study for any reason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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Medical Responsible
Role: Study Director
Affiliation: Merck KGaA, Darmstadt, Germany
Name: Communication Center
Phone: +49 6151 72 5200
Email: service@emdgroup.com
Facility | Status | Contact |
---|---|---|
Highlands Oncology Group (10694) Fayetteville, Arkansas 72703 United States |
Recruiting |
tbeck@hogonc.com |
St Joseph Heritage Healthcare Santa Rosa, California 95403 United States |
Recruiting |
wes.lee@stjoe.org |
Holy Cross Hospital - Michael and Dianne Bienes CCC Fort Lauderdale, Florida 33308 United States |
Recruiting |
ena.segota@holy-cross.com |
Florida Cancer Specialists (10711) Sarasota, Florida 34232 United States |
Recruiting |
mpatel@flcancer.com |
Virginia Piper Cancer Institute Minneapolis, Minnesota 55407 United States |
Recruiting |
samith.kochuparambil@usoncology.com |
Oncology Hematology Care (7757) Cincinnati, Ohio 45242 United States |
Recruiting |
david.waterhouse@usoncology.com |
Oregon Health & Science University Portland, Oregon 97201 United States |
Recruiting |
taylmatt@ohsu.edu |
The West Clinic Germantown, Tennessee 38138 United States |
Recruiting |
avanderw@westclinic.com |
SCRI - Tennessee Oncology Nashville, Tennessee 37203 United States |
Recruiting |
jbendell@tnonc.com |
Oncology Consultants, P.A. Houston, Texas 77030 United States |
Recruiting |
jpeguero@oncologyconsultants.com |
Clínica Universitaria Privada Reina Fabiola Cordoba, X5004FHP Argentina |
Recruiting |
Santiagorafaelbella@gmail.com |
Centre Hospitalier de l'Ardenne - Pharmacie Libramont, 6800 Belgium |
Recruiting |
frederic.forget@vivalia.be |
Please Contact the Communication Center Darmstadt, 64293 Germany |
Recruiting | |
National Cancer Center Hospital (NCCH) (12154) Chuo-ku, 104-0045 Japan |
Recruiting |
siwasa@ncc.go.jp |
Chonnam National University Hwasun Hospital (13868) Hwasun-gun, 58128 Korea, Republic of |
Recruiting |
kyc0923@chonnam.ac.kr |
Seoul National University Hospital Seoul, 03080 Korea, Republic of |
Recruiting |
ohdoyoun@snu.ac.kr |
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala Oradea, 410469 Romania |
Recruiting |
simonamihutiu@yahoo.com |
Pavlov First Saint Petersburg State Medical University - PARENT Saint-Petersburg, 197022 Russian Federation |
Recruiting |
orloff-sv@mail.ru |