This early phase I trial studies how well anti-PD-1 therapy consisting of pembrolizumab or nivolumab works in treating patients with classical Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory) with or without prior chimeric antigen receptor (CAR)-T cell therapy. Anti-PD-1 therapy with either pembrolizumab and nivolumab, block (inhibit) PD-1 or PD-L1 binding, which strengthens the immune response against cancer cells. This treatment basically prevents the cancer cells from hiding from cancer fighting T cells. Treatment with anti-PD-1 therapy may help strengthen T cells in Hodgkin lymphoma patients who have or have not received CAR-T cell therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04134325.
PRIMARY OBJECTIVE:
I. To evaluate the efficacy, as determined by objective response rate, of anti-PD-1 therapy after progression on CD30 CAR-T cell therapy in relapsed/refractory (r/r) classical Hodgkin lymphoma (cHL).
SECONDARY OBJECTIVES:
I. To measure the change in peripheral blood T-cell receptor clonality during treatment with anti-PD-1 therapy after progression on CD30 CAR-T cell therapy.
II. To measure the change in peripheral blood immunophenotype during treatment with anti-PD-1 therapy after progression on CD30 CAR-T cell therapy.
III. To estimate the progression free survival of anti-PD-1 therapy after progression on CD30 CAR-T cell therapy in r/r cHL.
EXPLORATORY OBJECTIVES:
I. To measure the expansion and persistence of CD30 CAR-T cells after treatment with anti-PD1 therapy in subjects with classical Hodgkin lymphoma who have progressed after CAR-T cell therapy.
II. To compare the change in peripheral blood immunophenotype during treatment with anti-PD-1 therapy in patients with and without prior CD30 CAR-T cell therapy.
III. To compare the change in peripheral blood T-cell receptor clonality during treatment with anti-PD-1 therapy with and without prior CD30 CAR-T cell therapy.
IV. To measure and compare changes in the tumor microenvironment during the course of anti-PD-1 therapy after CD30 CAR-T cell therapy.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients who have received prior CD30 CAR-T therapy receive standard of care nivolumab or pembrolizumab intravenously (IV) as clinically indicated.
ARM II: Patients who haven't received prior CD30 CAR-T therapy receive standard of care nivolumab or pembrolizumab IV as clinically indicated.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorNatalie S. Grover
