Clinical trial · Interventional
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cemiplimab | Drug | Cemiplimab | ALIAS |
| Involved-site radiotherapy (IS-RT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concomitant treatment
- description
- Treatment Group A
- interventionNames
- Drug: Cemiplimab
- Radiation: Involved-site radiotherapy (IS-RT)
- type
- EXPERIMENTAL
- label
- Sequential treatment
- description
- Treatment Group B
- interventionNames
- Drug: Cemiplimab
- Radiation: Involved-site radiotherapy (IS-RT)
Primary outcomes (1)
- measure
- Progression-free survival (PFS) at 1 year
- timeFrame
- From randomization up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available