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

• Status: Withdrawn
• Trial end date: 2025-02-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Cemiplimab

Criteria

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