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BRIEF TITLE: Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

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


  • Org Study ID: MS100070_0176
  • Secondary ID:
  • NCT ID: NCT03815643
  • NCT Alias:
  • Sponsor: EMD Serono Research & Development Institute, Inc. - Industry
  • Source: EMD Serono

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.

Overal Status Start Date Phase Study Type
Recruiting March 22, 2019 Phase 3 Interventional

Primary Outcomes:

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)

Condition:

  • Solid Tumors

Eligibility

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- Participant has been withdrawn from avelumab parent study for any reason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

Official Information

Name: Medical Responsible

Role: Study Director

Affiliation: Merck KGaA, Darmstadt, Germany

Overall Contact

Name: Communication Center

Phone: +49 6151 72 5200

Email: service@emdgroup.com

Locations

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