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

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial

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 Overview

• Status: Withdrawn
• Conditions: Hodgkin Lymphoma
• Intervention / Treatment: Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT)

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Concomitant treatment; Treatment Group A	Drug: Cemiplimab; Administered in 3-week intervals; Other Names: REGN2810; Libtayo; Radiation: 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
EXPERIMENTAL: Sequential treatment; Treatment Group B	Drug: Cemiplimab; Administered in 3-week intervals; Other Names: REGN2810; Libtayo; Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS) at 1 year	From randomization up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS at 2 and 3 years		From randomization up to 3 years
Overall survival (OS) at 1, 2, and 3 years		From randomization up to 3 years
Incidence of acute toxicities		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.	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.	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.	Up to 3 years
Rate of early discontinuation of study treatment		From first dose to up to 19 weeks
Frequency of lymphoma treatment administered in addition to study treatment		From randomization up to 3 years
Types of lymphoma treatment administered in addition to study treatment		From randomization up to 3 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 15, 2020
• Primary Completion (ANTICIPATED): December 20, 2022
• Study Completion (ANTICIPATED): February 20, 2025

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (ACTUAL): May 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Early Stage; Favorable; Classical; classical Hodgkin lymphoma (cHL)
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1615; 2017-004265-28 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes