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

Regeneron Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04373083

2017-004265-28 (EudraCT Number)

R2810-ONC-1615

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Concomitant treatment

Experimental group

Description:

Treatment Group A

Treatment:

Radiation: Involved-site radiotherapy (IS-RT)

Drug: Cemiplimab

Sequential treatment

Experimental group

Description:

Treatment Group B

Treatment:

Radiation: Involved-site radiotherapy (IS-RT)

Drug: Cemiplimab