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ACTIVE NOT RECRUITING Phase 1

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

NCT02651662 · View on ClinicalTrials.gov ↗

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)

Interventions

  • DRUG cemiplimab
  • DRUG odronextamab

Study Locations (20)

Other

  • Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III — Salzburg
  • Medical University Vienna — Vienna
  • University Hospital Frankfurt — Frankfurt am Main
  • Universitatsklinikum Jena — Jena
  • Universitatsklinikum Schleswig-Holstein, Campus Kiel — Kiel
  • Soroka — Beersheba
  • Hadassah Medical Center — Jerusalem
  • Chaim Sheba Medical Center — Ramat Gan
  • Tel Aviv Sourasky Medical Center — Tel Aviv
  • Pratia Onkologia Katowice — Katowice
  • Copernicus Memorial Hospital — Lodz
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa — Warsaw

Massachusetts

  • Dana Farber/Harvard Cancer Center - PO box 849168 — Boston
  • Harvard Medical School - Beth Israel Deaconess Medical Center — Boston

Maryland

  • Johns Hopkins University — Baltimore

Michigan

  • Cancer & Hematology Centers of Western Michigan — Grand Rapids

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland

Malopolska

  • Pratia MCM Krakow — Krakow

Pomeranian Voivodeship

  • Uniwersyteckie Centrum Kliniczne — Gdansk

Cantabria

  • Hospital Universitario Marques de Valdecilla — Santander

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2016-01-11
Est. Completion 2026-05-31
Phase Phase 1

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02651662

The ClinicalTrials.gov registry entry for NCT02651662 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsed/Refractory Aggressive B-Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions — of which cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02651662 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Massachusetts, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02651662 about?

NCT02651662 is a clinical study titled "A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies". 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...

What is the current status of trial NCT02651662?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2016-01-11. Estimated completion is 2026-05-31.

What conditions does trial NCT02651662 study?

This clinical trial studies the following conditions: Relapsed/Refractory Aggressive B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02651662?

The interventions under investigation include: cemiplimab (DRUG), odronextamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02651662?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02651662 being conducted?

This trial has 20 study locations across Maryland, Massachusetts, Michigan, Ohio, Malopolska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial