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

Regeneron Pharmaceuticals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hodgkin Lymphoma

Interventions

CemiplimabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Progression-free survival (PFS) at 1 year

Time frame: From randomization up to 1 year

Secondary Outcomes

PFS at 2 and 3 years

Time frame: From randomization up to 3 years

Overall survival (OS) at 1, 2, and 3 years

Time frame: From randomization up to 3 years

Incidence of acute toxicities

Time frame: Up to 90 days after study treatment

Rate of patients with long-term fatigue using EORTC-QLQ-FA12

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). -FA12 module complements the core EORTC QLQ-C30 questionnaire regarding fatigue. Each item can be scored in four dimension on a scale from 1 to 4 with higher scores indicating worse symptoms.

Time frame: 12-18 months after randomization

Rate of patients with long-term fatigue using EORTC-QLQ-C30

Scores range from 0 to 100. A high scale score represents a higher response level.

Time frame: 12-18 months after randomization

Quality of life (QoL) using EORTC-QLQ-30

Scores range from 0 to 100. A high scale score represents a higher response level.

Time frame: Up to 3 years

Rate of early discontinuation of study treatment

Time frame: From first dose to up to 19 weeks

Frequency of lymphoma treatment administered in addition to study treatment

Data from ClinicalTrials.gov

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