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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04373083
Collaborator
Sanofi (Industry)
0
Enrollment
2
Arms
51.2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
Anticipated Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Feb 20, 2025

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) at 1 year [From randomization up to 1 year]

    Secondary Outcome Measures

    1. PFS at 2 and 3 years [From randomization up to 3 years]

    2. Overall survival (OS) at 1, 2, and 3 years [From randomization up to 3 years]

    3. Incidence of acute toxicities [Up to 90 days after study treatment]

    4. 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.

    5. 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.

    6. 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.

    7. Rate of early discontinuation of study treatment [From first dose to up to 19 weeks]

    8. Frequency of lymphoma treatment administered in addition to study treatment [From randomization up to 3 years]

    9. Types of lymphoma treatment administered in addition to study treatment [From randomization up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Sanofi

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04373083
    Other Study ID Numbers:
    • R2810-ONC-1615
    • 2017-004265-28
    First Posted:
    May 4, 2020
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Regeneron Pharmaceuticals
    Early Stage
    Favorable
    Classical
    classical Hodgkin lymphoma (cHL)
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Cemiplimab

    Study Results

    No Results Posted as of Jan 15, 2021