Hodgkin LymphomaPhase 2NCT04373083
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma
A Phase 2 study testing Cemiplimab and Involved-site radiotherapy (IS-RT) in people with Hodgkin Lymphoma, run by Regeneron Pharmaceuticals.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Cemiplimab and Involved-site radiotherapy (IS-RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2020to 20 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven classical HL
- First diagnosis, no previous treatment
- Stage I-II without risk factors as defined in the protocol
Who cannot join
- 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
About this study
Official title: Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
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.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Cemiplimab, Involved-site radiotherapy (IS-RT)
- Keywords
- Early Stage, Favorable, Classical, classical Hodgkin lymphoma (cHL)
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, Libtayo
Administered in 3-week intervals
Involved-site radiotherapy (IS-RT)Radiation
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
| Study group | Role | What they receive |
|---|---|---|
| Concomitant treatment | Experimental | Treatment Group A Receives: Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT) |
| Sequential treatment | Experimental | Treatment Group B Receives: Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) at 1 year
Measured: From randomization up to 1 year
Secondary outcomes (9)
PFS at 2 and 3 years
Measured: From randomization up to 3 years
Overall survival (OS) at 1, 2, and 3 years
Measured: From randomization up to 3 years
Incidence of acute toxicities
Measured: Up to 90 days after study treatment
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.
Measured: 12-18 months after randomization
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.
Measured: 12-18 months after randomization
Quality of life (QoL) using EORTC-QLQ-30
Scores range from 0 to 100. A high scale score represents a higher response level.
Measured: Up to 3 years
Rate of early discontinuation of study treatment
Measured: From first dose to up to 19 weeks
Frequency of lymphoma treatment administered in addition to study treatment
Measured: From randomization up to 3 years
Types of lymphoma treatment administered in addition to study treatment
Measured: From randomization up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start15 Nov 2020 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Feb 2025 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373083
- Sponsor's protocol ID
- R2810-ONC-1615
- Other IDs
- 2017-004265-28, 2017
- Status last verified
- Dec 2020
- First submitted
- 15 Apr 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT04373083
- Acronym / sponsor ID
- R2810-ONC-1615
- Conditions
- Hodgkin Lymphoma
- Keywords
- Early Stage, Favorable, Classical, classical Hodgkin lymphoma (cHL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant treatment | Experimental | Drug: Cemiplimab, Radiation: Involved-site radiotherapy (IS-RT)Treatment Group A |
| Sequential treatment | Experimental | Drug: Cemiplimab, Radiation: Involved-site radiotherapy (IS-RT)Treatment Group B |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven classical HL
- First diagnosis, no previous treatment
- Stage I-II without risk factors as defined in the protocol
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: REGN2810, LibtayoAdministered in 3-week intervals | Drug | Concomitant treatment, Sequential treatment |
| 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 | Radiation | Concomitant treatment, Sequential treatment |
Primary outcome
Progression-free survival (PFS) at 1 year
Time frame: From randomization up to 1 year
9 secondary outcomes
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
Rate of patients with long-term fatigue using EORTC-QLQ-C30
Time frame: 12-18 months after randomization
Quality of life (QoL) using EORTC-QLQ-30
Time frame: Up to 3 years
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab and Involved-site radiotherapy (IS-RT) in people with Hodgkin Lymphoma, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) at 1 year (time frame: From randomization up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.