search
Back to results

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

Primary Purpose

Hodgkin Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cemiplimab
Involved-site radiotherapy (IS-RT)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Early Stage, Favorable, Classical, classical Hodgkin lymphoma (cHL)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Concomitant treatment

    Sequential treatment

    Arm Description

    Treatment Group A

    Treatment Group B

    Outcomes

    Primary Outcome Measures

    Progression-free survival (PFS) at 1 year

    Secondary Outcome Measures

    PFS at 2 and 3 years
    Overall survival (OS) at 1, 2, and 3 years
    Incidence of acute toxicities
    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.
    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.
    Quality of life (QoL) using EORTC-QLQ-30
    Scores range from 0 to 100. A high scale score represents a higher response level.
    Rate of early discontinuation of study treatment
    Frequency of lymphoma treatment administered in addition to study treatment
    Types of lymphoma treatment administered in addition to study treatment

    Full Information

    First Posted
    April 15, 2020
    Last Updated
    January 13, 2021
    Sponsor
    Regeneron Pharmaceuticals
    Collaborators
    Sanofi
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04373083
    Brief Title
    Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma
    Official Title
    Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business Decision
    Study Start Date
    November 15, 2020 (Anticipated)
    Primary Completion Date
    December 20, 2022 (Anticipated)
    Study Completion Date
    February 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Regeneron Pharmaceuticals
    Collaborators
    Sanofi

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hodgkin Lymphoma
    Keywords
    Early Stage, Favorable, Classical, classical Hodgkin lymphoma (cHL)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Concomitant treatment
    Arm Type
    Experimental
    Arm Description
    Treatment Group A
    Arm Title
    Sequential treatment
    Arm Type
    Experimental
    Arm Description
    Treatment Group B
    Intervention Type
    Drug
    Intervention Name(s)
    Cemiplimab
    Other Intervention Name(s)
    REGN2810, Libtayo
    Intervention Description
    Administered in 3-week intervals
    Intervention Type
    Radiation
    Intervention Name(s)
    Involved-site radiotherapy (IS-RT)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Progression-free survival (PFS) at 1 year
    Time Frame
    From randomization up to 1 year
    Secondary Outcome Measure Information:
    Title
    PFS at 2 and 3 years
    Time Frame
    From randomization up to 3 years
    Title
    Overall survival (OS) at 1, 2, and 3 years
    Time Frame
    From randomization up to 3 years
    Title
    Incidence of acute toxicities
    Time Frame
    Up to 90 days after study treatment
    Title
    Rate of patients with long-term fatigue using EORTC-QLQ-FA12
    Description
    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.
    Time Frame
    12-18 months after randomization
    Title
    Rate of patients with long-term fatigue using EORTC-QLQ-C30
    Description
    Scores range from 0 to 100. A high scale score represents a higher response level.
    Time Frame
    12-18 months after randomization
    Title
    Quality of life (QoL) using EORTC-QLQ-30
    Description
    Scores range from 0 to 100. A high scale score represents a higher response level.
    Time Frame
    Up to 3 years
    Title
    Rate of early discontinuation of study treatment
    Time Frame
    From first dose to up to 19 weeks
    Title
    Frequency of lymphoma treatment administered in addition to study treatment
    Time Frame
    From randomization up to 3 years
    Title
    Types of lymphoma treatment administered in addition to study treatment
    Time Frame
    From randomization up to 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trial Management
    Organizational Affiliation
    Regeneron Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 URL
    https://vivli.org/

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs