Avelumab Program Rollover Study

  • STATUS
    Recruiting
  • End date
    Jan 28, 2024
  • participants needed
    161
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 16 April 2021
avelumab

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.

Details
Condition Solid Tumors, Solid Neoplasm, Solid Tumour
Treatment Avelumab
Clinical Study IdentifierNCT03815643
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Solid Tumors?
Do you have any of these conditions: Solid Tumour or Solid Neoplasm or Solid Tumors?
Do you have any of these conditions: Solid Neoplasm or Solid Tumors or Solid Tumour?
Do you have any of these conditions: Solid Neoplasm or Solid Tumour or Solid Tumors?
Do you have any of these conditions: Solid Neoplasm or Solid Tumour or Solid Tumors?
Do you have any of these conditions: Solid Neoplasm or Solid Tumour or Solid Tumors?
Do you have any of these conditions: Solid Neoplasm or Solid Tumour or Solid Tumors?
Do you have any of these conditions: Solid Tumors or Solid Tumour or Solid Neoplasm?
Do you have any of these conditions: Solid Tumors or Solid Neoplasm or Solid Tumour?
Do you have any of these conditions: Solid Neoplasm or Solid Tumors or Solid Tumour?
Do you have any of these conditions: Solid Tumors or Solid Tumour or Solid Neoplasm?
Do you have any of these conditions: Solid Neoplasm or Solid Tumors or Solid Tumour?
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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