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This research is studying the safety and effectiveness of AMD3100 and pembrolizumab in participants with metastatic head and neck squamous cell carcinoma.
Full description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug combination works in treating a specific disease. "Investigational" means that the drug is being studied.
Because AMD3100 and Pembrolizumab have not been administered together to individuals before, there will be a Run-In phase prior to the beginning of Phase II. This Run-In Phase is designed to identify what dosing schedule is best for participants on this study. Participants will be participating in the Run-In Phase.
The U.S. Food and Drug Administration (FDA) has approved Pembrolizumab as a treatment option for this disease.
The FDA has not approved AMD3100 as a treatment option for this disease, however it has approved the drug for use in individuals who have recently had bone marrow transplants.
Pembrolizumab is thought to block a receptor called PD-1. This receptor usually acts as a "brake" to prevent the body's immune system from attacking cancer cells. The antibody "removes the brake" to allow parts of the body's immune system (usually T cells) to attack the tumor
AMD3100 is a drug that inhibits CXCR4, which is a biological mechanism called a chemokine. CXCR4 is over-expressed in cancer cells and promotes cancer cell growth, spread, and survival and controls immune cell trafficking. Researchers believe that inhibiting CXCR4 expels the immune-suppressive cells out of the tumor and attract the cancer-killing immune cells into the tumor environment so that the body's immune system may be able to better attack the cancer cells.
In this research study, the investigators are assessing the safety and effectiveness of AMD3100 and pembrolizumab in participants with aggressive head and neck squamous cell carcinoma.
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Inclusion criteria
Have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the recurrent or metastatic head and neck. For oropharyngeal cancer, tumor HPV status must be known.
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Have progressed on or after immune checkpoint therapy (anti-PD-1 or anti-PD-L1, as a monotherapy or in combination with other agents). Anti-PD-1/PD-L1 immune checkpoint therapy does not have to be the most immediate prior therapy before the study enrollment.
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. If slides are to be submitted, 10-20 unstained slides are required. Newly obtained biopsies are preferred to archived tissue. At a minimum, 3 core biopsies will be obtained and 1 core will be formalin fixed and the other 2 cores will be flash frozen.
Have a lesion that is accessible for biopsy for subjects in the Run-In phase. An exception can be granted for those patients who do not have a lesion that can be safely biopsied based upon review with the Principal Investigator. The tumor biopsy is optional in the Phase II portion of the study
Be >18 years of age on the day of signing informed consent.
ECOG performance status ≤ 1 (Karnofsky ≥70%, see Appendix A).
Have normal organ and marrow function as defined below. Specimens must be collected within 28 days prior to study registration.
Ability to understand and the willingness to sign a written informed consent document.
Male participants:
A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
-Female participants:
A female participant is eligible to participate if she is not pregnant (see Appendix C), not breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
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0 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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