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A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

NCT02651662 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-02-02

No results posted yet for this study

Summary

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)

Conditions

  • Relapsed/Refractory Aggressive B-Cell Lymphoma

Interventions

DRUG

odronextamab

Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.

DRUG

cemiplimab

Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-11
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Germany
  • Israel
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651662 on ClinicalTrials.gov