A Rollover Study of Experimental Avelumab for Solid Tumor Cancer

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: cancer, antibodies, monoclonal antibodies, solid tumors
Type: Drug study, Phase 3
Target:
2 Participants
Investigator:
Description
Avelumab is a monoclonal antibody. This means it is an antibody that is active against a single specific target structure. Antibodies are usually produced naturally by the body’s immune system. They protect the body from sources of infection or agents that may be harmful to the body. Artificial antibodies, such as the study drug, can be made into medications to help prevent the growth or spread of cancer. The specific target structure that the study drug is active against may be present on the type of cancer you have.

You are invited to take part in this roll-over clinical research study. It is for patients who were treated with the study drug avelumab in another clinical research study. Participants from several studies on avelumab (referred to as “parent studies”) are invited to take part.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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  • Participant has been withdrawn from avelumab parent study for any reason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.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The length of your participation in this study will depend on how long you receive avelumab. You may continue to be followed up until 5 years after you have received the last dose of avelumab.
Recruitment period
From April 29, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Carolyn King
Research Topic
Conditions:
  • Solid Tumors