Protocol
12-127
Full Title
A Phase 1, Multi-Center, Open-Label, Two-Stage Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMP-224 in a Regimen Containing Cyclophosphamide in Patients with Advanced Solid Malignancies
Purpose
The purpose of this study is to evaluate the safety and preliminary effectiveness of an investigational drug called AMP-224 when given with the conventional chemotherapy agent cyclophosphamide in patients with advanced melanoma that is no longer responding to standard treatments.
AMP-224 boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells.
AMP-224 binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells. It is hoped that by combining it with chemotherapy drugs, such as cyclophosphamide, cancer cell death can be enhanced.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced cutaneous melanoma that is no longer responding to standard treatments.
- Patients must have disease that progressed despite a BRAF inhibitor.
- Patients must have recovered from the serious side effects of prior therapies before entering the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Mark A. Dickson at 646-888-4164.
Disease(s)
Melanoma
Locations
Related Diseases
