Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Solid Tumors, Avelumab, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Urothelial carcinoma (UC), Ovarian cancer

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

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  • Participant has been withdrawn from avelumab parent study for any reason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

  • University of California Davis Health System - Comprehensive Cancer Center
    Sacramento California 95817 United States
  • Providence Medical Foundation
    Santa Rosa California 95403 United States
  • St Joseph Heritage Healthcare
    Santa Rosa California 95403 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
Links
Trial Awareness and Transparency website
ID
NCT03815643
Phase
Phase 3 Solid Tumor Research Study
Study Type
Interventional
Participants
About 205 people participating
Last Updated