IRB #

STUDY00016046

Title

Response Assessment to Pembrolizumab with Standard of Care Therapy in Oligometastatic Brain Tumors from Melanoma, and Glioblastoma Using Ferumoxytol Steady State Imaging– A Pilot Study

Principal Investigator

Prakash Ambady

Study Purpose

In this study, we will test an MRI contrast agent called ferumoxytol, to see if it is helpful in viewing your brain tumor, and in particular, the blood vessels in and around the tumor, in a different way than the standard contrast agent, gadolinium.

In this study, you will also receive pembrolizumab, which is an experimental drug that when given with standard care radiation or chemotherapy, could shrink your tumor(s). Pembrolizumab (also known as Keytruda) is experimental, however has already been FDA-approved to treat other cancers. This study will look at how well your tumor(s) respond to pembrolizumab.

Medical Condition(s)

Metastatic melanoma and glioblastoma

Eligibility Criteria

In order to be eligible for participation in this trial, the subject must:
1. Be ≥18 years of age on day of signing informed consent.

2. Have a life expectancy of at least 6 months.

3. Have a confirmed diagnosis of:
Group 1: Metastatic melanoma to the brain OR
Group 2: Glioblastoma

4. At least 30 days from any major surgeries including brain biopsy and have complete resolution of its effects.

5. All subjects of childbearing potential should be willing to use adequate method of contraception or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.

6. Criteria specific to each arm:
Arm 1:
• Must agree to standard of care radiation
• There are no restrictions on the number of prior lines of treatment for cancer in the body (outside of the brain)
• If subjects have known brain disease that were treated previously with local therapies, surgery, and/or radiation, these lesions must be stable for at least 30 days prior to enrollment.

Arm 2: Subject is eligible for and agrees to receive standard of care radiation and temozolamide after surgery

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

2 years on study drug, and then followed for disease status

Minors Included

No

Contact

Riley Roth-Carter 503-494-5626, rothcarr@ohsu.edu

Sponsor

Merck

Recruitment End

12/31/2020

Compensation Provided

No


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