Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT04373083 |
Recruitment Status :
Withdrawn
(Business Decision)
First Posted : May 4, 2020
Last Update Posted : January 15, 2021
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Concomitant treatment
Treatment Group A
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Drug: Cemiplimab
Administered in 3-week intervals
Other Names:
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:
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 |
- Progression-free survival (PFS) at 1 year [ Time Frame: From randomization up to 1 year ]
- PFS at 2 and 3 years [ Time Frame: From randomization up to 3 years ]
- Overall survival (OS) at 1, 2, and 3 years [ Time Frame: From randomization up to 3 years ]
- Incidence of acute toxicities [ Time Frame: Up to 90 days after study treatment ]
- 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.
- 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.
- 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.
- Rate of early discontinuation of study treatment [ Time Frame: From first dose to up to 19 weeks ]
- Frequency of lymphoma treatment administered in addition to study treatment [ Time Frame: From randomization up to 3 years ]
- Types of lymphoma treatment administered in addition to study treatment [ Time Frame: From randomization up to 3 years ]

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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 |
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

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
Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
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/ |
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 |
Early Stage Favorable Classical classical Hodgkin lymphoma (cHL) |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Cemiplimab Antineoplastic Agents, Immunological Antineoplastic Agents |