cemiplimab
DrugAdministration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
Other names: REGN2810, Libtayo
NCT Number: NCT02651662
This study is researching a combination of 2 experimental drugs, referred to as "study drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose regimen for the combination with odronextamab.
This study is also looking at several other research questions, including:
* What side effects may happen from taking the study drugs * How effective the study drugs are against the disease * How much study drug is in the blood at different times * Whether the body makes substances or protein called antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III, Salzburg, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
Other names: REGN2810, Libtayo
Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.
Other names: REGN1979
Time frame: Up to 28 days
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Time frame: Up to 18 months
Regeneron Pharmaceuticals
Industry
A Phase 1 Study to Assess Safety and Tolerability of Odronextamab (REGN1979) an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and Cemiplimab (REGN2810), an Anti-Programmed Death-1 Monoclonal Antibody in Patients With B-Cell Malignancies (CLIO-1)
Acronym: CLIO-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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