Status:
WITHDRAWN
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- Key
- Histologically proven classical HL
- First diagnosis, no previous treatment
- Stage I-II without risk factors as defined in the protocol
- Key
Exclusion
- 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
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04373083
Start Date
November 15 2020
End Date
February 20 2025
Last Update
January 15 2021
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