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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373083
Recruitment Status : Withdrawn (Business Decision)
First Posted : May 4, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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
Hodgkin Lymphoma Drug: Cemiplimab Radiation: Involved-site radiotherapy (IS-RT) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : February 20, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Progression-free survival (PFS) at 1 year [ Time Frame: From randomization up to 1 year ]

Secondary Outcome Measures :
  1. PFS at 2 and 3 years [ Time Frame: From randomization up to 3 years ]
  2. Overall survival (OS) at 1, 2, and 3 years [ Time Frame: From randomization up to 3 years ]
  3. Incidence of acute toxicities [ Time Frame: Up to 90 days after study treatment ]
  4. Rate of patients with long-term fatigue using EORTC-QLQ-FA12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From first dose to up to 19 weeks ]
  8. Frequency of lymphoma treatment administered in addition to study treatment [ Time Frame: From randomization up to 3 years ]
  9. Types of lymphoma treatment administered in addition to study treatment [ Time Frame: From randomization up to 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373083


Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04373083    
Other Study ID Numbers: R2810-ONC-1615
2017-004265-28 ( EudraCT Number )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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).
URL: https://vivli.org/

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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:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents