Clareo Health | A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)
A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
The master screening protocol is MK-9999-U01.
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid tumors that are tumor mutational burden-high (TMB-H)
Must have recovered from all AEs from previous anticancer therapies
Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
You may not be if
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Received prior anticancer therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) in combination with either an Anti- lymphocyte-activation gene 3 (LAG-3) agent or an Anti- T-cell immunoreceptor with immunoglobulin (Ig) and ITIM domains (TIGIT) agent
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Known additional malignancy that is progressing or has required active treatment within the past 1 year
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in the past 2 years
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Active infection requiring systemic therapy
Concurrent active Hepatitis B and Hepatitis C virus infection
History of allogenic tissue/solid organ transplant
Has symptoms of or is being treated for graft versus host disease (GVHD)
Has not adequately recovered from major surgery or have ongoing surgical complications
