ADVL1621 – A Phase I/II Study of Pembrolizumab (MK-3475) in Children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma
Patients must have either advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma. PD-L1 testing is performed as part of screening for the study. Patient’s current disease state must be one for which there are no known curative treatment options or therapies proven to prolong survival with an acceptable quality of life.
Pembrolizumab is a highly selective humanized monoclonal antibody that inhibits programmed cell death-1 (PD-1) activity by binding to the PD-1 receptor to block PD-1 ligands (PD-L1 and PD-L2) from binding. Blocking this pathway inhibits negative immune regulation caused by PD-1 receptor signaling, reverses T-cell suppression, thus inducing antitumor responses. Pembrolizumab will be administered as a 30 minute IV infusion every 3 weeks. Therapy may continue for up to 2 years in the absence of disease-progression or unacceptable toxicities.
- Patients must be between 6 months and 18 years of age.
- Must have adequate tissue from an archival sample (or new biopsy, if indicated) to send for PD-L1 expression.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and have the appropriate wash-out period from most recent cancer directed therapy.
- Must have adequate organ function as evidenced by laboratory criteria.
- Patients must not have a diagnosis of immunodeficiency or be receiving any form of immunosuppressive therapy or systemic steroids (physiologic replacement doses may be allowed after consultation with study Sponsor).
- Patients with CNS metastases must be stable (i.e. not show progressive disease on imaging and clinically asymptomatic, no new or enlarging brain mets allowed). Patients with primary CNS tumors must be neurologically stable, not requiring systemic steroids, and not have involvement of the brain stem.
- Must not have an autoimmune disease requiring systemic treatment in the past 2 years.
- Must not have received previous immune checkpoint inhibitors, except for patients with melanoma who may have received prior ipilimumab.
- Must not have known HIV Hepatitis B or C, or an uncontrolled infection.
- Must not have had a prior allogeneic hematopoetic stem cell transplant within the last 5 years.
For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at firstname.lastname@example.org.