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

Study Overview
=================
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.

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

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Cemiplimab
* Radiation: Involved-site radiotherapy (IS-RT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant treatment<br>Treatment Group A | Drug: Cemiplimab<br>* Administered in 3-week intervals<br>* Other names: Libtayo;Radiation: Involved-site radiotherapy (IS-RT)<br>* 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<br>|
| Experimental: Sequential treatment<br>Treatment Group B | Drug: Cemiplimab<br>* Administered in 3-week intervals<br>* Other names: Libtayo;Radiation: Involved-site radiotherapy (IS-RT)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early Stage, Favorable, Classical, classical Hodgkin lymphoma (cHL)