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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04373083
• Other study ID #: R2810-ONC-1615
• Secondary ID: 2017-004265-28
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 15, 2020
• Est. completion date: February 20, 2025

Study information

• Verified date: December 2020
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 20, 2025
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• Cemiplimab
Administered in 3-week intervals

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) at 1 year		From randomization up to 1 year
Secondary	PFS at 2 and 3 years		From randomization up to 3 years
Secondary	Overall survival (OS) at 1, 2, and 3 years		From randomization up to 3 years
Secondary	Incidence of acute toxicities		Up to 90 days after study treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of early discontinuation of study treatment		From first dose to up to 19 weeks
Secondary	Frequency of lymphoma treatment administered in addition to study treatment		From randomization up to 3 years
Secondary	Types of lymphoma treatment administered in addition to study treatment		From randomization up to 3 years