IRB #

IRB00010177

Title

A Phase I, Open-Label, Multiple-Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of avelumab (MSB0010718C) in Subjects with Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Principal Investigator

Matthew Taylor

Study Purpose

The purpose of this study is to test MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks.

Medical Condition(s)

1. Non-small cell lung cancer (first line or post platinum doublet)
2. Gastric or GEJ cancer (first line maintenance, second line, or third line)
3. Melanoma
4. Ovarian cancer (recurrent or platinum refractory)
5. ACC
6. Mesothelioma
7. Urothelial carcinoma (platinum ineligible or progressed after at least 1 platinum-based therapy)
8. Renal cell carcinoma (first-line and second-line)
9. Head and neck cancer (platinum ineligible or progressed after at least 1 platinum-based therapy)

Eligibility Criteria

1. Males and females at least 18 years or older
2. Diagnosis of one of the cancer types listed above.
3. No history of cancer that has spread to the central nervous system.
4. Other criteria may apply.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until your cancer gets worse or you develop unacceptable side effects

Minors Included

No

Contact

Knight Information Line
503-494-1080

Sponsor

EMD Serono, Inc.

Recruitment End

07/31/2016

Compensation Provided

No


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