Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL).

Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.

Key Inclusion Criteria:

• Histologically proven classical HL
• First diagnosis, no previous treatment
• Stage I-II without risk factors as defined in the protocol

Key Exclusion Criteria:

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
• Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
• Prior chemotherapy or radiation therapy
• Concurrent disease precluding protocol treatment as defined in the protocol
• Pregnancy or breast-feeding
• Non-compliance as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply