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

NCT ID: NCT04373083

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2025-02-20

Brief 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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concomitant treatment

Treatment Group A

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Administered in 3-week intervals

Involved-site radiotherapy (IS-RT)

Intervention Type: RADIATION

Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol

Sequential treatment

Treatment Group B

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Administered in 3-week intervals

Involved-site radiotherapy (IS-RT)

Intervention Type: RADIATION

Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol

Interventions

Cemiplimab

Administered in 3-week intervals

Intervention Type: DRUG

Involved-site radiotherapy (IS-RT)

Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol

Intervention Type: RADIATION

Other Intervention Names

REGN2810; Libtayo

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Other Identifiers

2017-004265-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R2810-ONC-1615

Identifier Type: -

Identifier Source: org_study_id