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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04373083
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Administered in 3-week intervals
  • Involved-site radiotherapy (IS-RT) — 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

Study Details

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 Dates

Start date
Nov 15, 2020
Status verified
Dec 2020
Primary completion
Dec 20, 2022
Completion
Feb 20, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Concomitant treatment
    Treatment Group A
  • Experimental: Sequential treatment
    Treatment Group B

Primary Outcome Measure

Progression-free survival (PFS) at 1 year [ Time Frame: From randomization up to 1 year ]

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