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)

Conditions: Neoplasm Metastasis

Summary: this study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical hodgkin lymphoma (chl) solid tumors with microsatellite instability-high (msi-h)/mismatch repair deficient (dmmr) or tumor mutational burden-high (tmb-h). this study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (rp2d) (part 1) followed by an efficacy evaluation (part 2). participants will be assigned to a treatment arm (either part 1 or part 2) that is open for enrollment. there will be no hypothesis testing in this study.

the master screening protocol is mk-9999-u01.

Eligibility criteria:
inclusion criteria: * 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) exclusion criteria: * 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 * known tumors involving the brainstem