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Avelumab Program Rollover Study
Avelumab Program Rollover Study

NCT03815643

Active Not RecruitingPhase 3

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions: Solid Tumors

Interventions: Avelumab

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Czechia, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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* Participant has been withdrawn from avelumab parent study for any reason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.
Locations (104)
  • Scottsdale, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Sacramento, California, United States
  • Santa Rosa, California, United States
  • Santa Rosa, California, United States
  • Norwalk, Connecticut, United States
  • Port Saint Lucie, Florida, United States
  • Marietta, Georgia, United States
  • Rockville, Maryland, United States
  • Lansing, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Kansas City, Missouri, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Providence, Rhode Island, United States
  • Charleston, South Carolina, United States
  • Greenville, South Carolina, United States
  • Germantown, Tennessee, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Burlington, Vermont, United States
  • Ciudad Autonoma Buenos Aires, Argentina
  • Córdoba, Argentina
  • Ballarat, Australia
  • Clayton, Australia
  • + 74 more on CT.gov