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Brief Title: Avelumab Program Rollover Study

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

INTRODUCTION

  • Org Study ID: MS100070_0176
  • Secondary ID: N/A
  • NCT ID: NCT03815643
  • Sponsor: EMD Serono Research & Development Institute, Inc.

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.


  • Overall Status
    Recruiting
  • Start Date
    March 22, 2019
  • Phase
    Phase 3
  • Study Type
    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 - Timeframe: 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


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- Participant has been withdrawn from avelumab parent study for any reason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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Responsible

Role: Study Director

Affiliation: Merck KGaA, Darmstadt, Germany

Overall Contact

Name: Medical Responsible

Phone: +49 6151 72 5200

Email: service@emdgroup.com

LOCATION

Facility Status Contact
Facility: Highlands Oncology Group (10694)
Fayetteville, Arkansas 72703
United States 		Status: Recruiting Contact:
tbeck@hogonc.com
Facility: St Joseph Heritage Healthcare
Santa Rosa, California 95403
United States 		Status: Recruiting Contact:
wes.lee@stjoe.org
Facility: Holy Cross Hospital - Michael and Dianne Bienes CCC
Fort Lauderdale, Florida 33308
United States 		Status: Recruiting Contact:
ena.segota@holy-cross.com
Facility: Florida Cancer Specialists (10711)
Sarasota, Florida 34232
United States 		Status: Recruiting Contact:
mpatel@flcancer.com
Facility: Virginia Piper Cancer Institute
Minneapolis, Minnesota 55407
United States 		Status: Recruiting Contact:
samith.kochuparambil@usoncology.com
Facility: Oncology Hematology Care (7757)
Cincinnati, Ohio 45242
United States 		Status: Recruiting Contact:
david.waterhouse@usoncology.com
Facility: Oregon Health & Science University
Portland, Oregon 97201
United States 		Status: Recruiting Contact:
taylmatt@ohsu.edu
Facility: The West Clinic
Germantown, Tennessee 38138
United States 		Status: Recruiting Contact:
avanderw@westclinic.com
Facility: SCRI - Tennessee Oncology
Nashville, Tennessee 37203
United States 		Status: Recruiting Contact:
jbendell@tnonc.com
Facility: Oncology Consultants, P.A.
Houston, Texas 77030
United States 		Status: Recruiting Contact:
jpeguero@oncologyconsultants.com
Facility: Clínica Universitaria Privada Reina Fabiola
Cordoba, X5004FHP
Argentina 		Status: Recruiting Contact:
Santiagorafaelbella@gmail.com
Facility: Centre Hospitalier de l'Ardenne - Pharmacie
Libramont, 6800
Belgium 		Status: Recruiting Contact:
frederic.forget@vivalia.be
Facility: Please Contact the Communication Center
Darmstadt, 64293
Germany 		Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital (NCCH) (12154)
Chuo-ku, 104-0045
Japan 		Status: Recruiting Contact:
siwasa@ncc.go.jp
Facility: Chonnam National University Hwasun Hospital (13868)
Hwasun-gun, 58128
Korea, Republic of 		Status: Recruiting Contact:
kyc0923@chonnam.ac.kr
Facility: Seoul National University Hospital
Seoul, 03080
Korea, Republic of 		Status: Recruiting Contact:
ohdoyoun@snu.ac.kr
Facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala
Oradea, 410469
Romania 		Status: Recruiting Contact:
simonamihutiu@yahoo.com
Facility: Pavlov First Saint Petersburg State Medical University - PARENT
Saint-Petersburg, 197022
Russian Federation 		Status: Recruiting Contact:
orloff-sv@mail.ru

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