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

Phase 2

Withdrawn

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT)

• Registration Number: NCT04373083
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-04
• Study Start: 2020-11-15
• Status Verified: 2020-12
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Primary Completion: 2022-12-20
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concomitant treatment	Involved-site radiotherapy (IS-RT)	Treatment Group A
Sequential treatment	Cemiplimab	Treatment Group B
Concomitant treatment	Cemiplimab	Treatment Group A
Sequential treatment	Involved-site radiotherapy (IS-RT)	Treatment Group B

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) at 1 year	From randomization up to 1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS) at 1, 2, and 3 years	From randomization up to 3 years
Rate of patients with long-term fatigue using EORTC-QLQ-FA12	12-18 months after randomization	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.
Types of lymphoma treatment administered in addition to study treatment	From randomization up to 3 years
PFS at 2 and 3 years	From randomization up to 3 years
Quality of life (QoL) using EORTC-QLQ-30	Up to 3 years	Scores range from 0 to 100. A high scale score represents a higher response level.
Rate of early discontinuation of study treatment	From first dose to up to 19 weeks
Incidence of acute toxicities	Up to 90 days after study treatment
Frequency of lymphoma treatment administered in addition to study treatment	From randomization up to 3 years
Rate of patients with long-term fatigue using EORTC-QLQ-C30	12-18 months after randomization	Scores range from 0 to 100. A high scale score represents a higher response level.