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

NCT02651662 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: R1979-ONC-15042015-001697-172023-508209-25-00
• Study Type: interventional
• Target: 105
• Locations: 6 countries
• Sites: 30

Brief 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

Keywords

B-Cell Non-Hodgkin Lymphoma (B-NHL)

Outcome Measures

Primary Outcomes (5)

• Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab

  Up to 28 days

• Incidence of treatment emergent adverse events (TEAEs) of cemiplimab in combination with odronextamab

  Up to 18 months

• Severity of TEAEs of cemiplimab in combination with odronextamab

  Up to 18 months

• Incidence of adverse events of special interest (AESIs) of cemiplimab in combination with odronextamab

  Up to 18 months

• Severity of AESIs of cemiplimab in combination with odronextamab

  Up to 18 months

Secondary Outcomes (8)

• Odronextamab and cemiplimab concentrations in serum

  Up to 18 months

• Incidence of anti-drug antibodies (ADAs) to odronextamab and cemiplimab over time

  Up to 18 months

• Titer of ADAs to odronextamab and cemiplimab over time

  Up to 18 months

• Incidence of neutralizing antibodies (Nabs) to odronextamab and cemiplimab over time

  Up to 18 months

• Titer of Nabs to odronextamab and cemiplimab over time

  Up to 18 months

Study Arms (2)

Dose escalation phase

EXPERIMENTAL

Safety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab.

Drug: cemiplimab; Drug: odronextamab

Dose expansion phase

EXPERIMENTAL

RP2D administration of the combination treatment.

Drug: cemiplimab; Drug: odronextamab

Interventions

cemiplimab DRUG

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

Also known as: REGN2810, Libtayo

Dose escalation phase; Dose expansion phase

odronextamab DRUG

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

Also known as: REGN1979

Dose escalation phase; Dose expansion phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have documented CD20+ aggressive B-cell NHL that is either not responsive to or relapsed after at least 2 prior lines of systemic therapy, for whom treatment with an anti-CD20 antibody may be appropriate. In addition, prior treatments should at least contain an anti-CD20 antibody and an alkylating agent.
• Must have at least 1 nodal lesion (≥1.5 cm), or at least one extranodal lesion with longest transverse diameter (LDi) greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Adequate bone marrow and hepatic function, as defined in the protocol
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

You may not qualify if:

• Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL
• History of or current relevant CNS pathology, as described in the protocol
• Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (iAEs)
• Prior therapies, as described in the protocol
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
• Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled.
• Known hypersensitivity to both allopurinol and rasburicase
• Pregnant or breastfeeding women
• Women of childbearing potential, or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose, as defined in the protocol
• Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (30)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Dana Farber/Harvard Cancer Center - PO box 849168

Boston, Massachusetts, 02215, United States

Location

Harvard Medical School - Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49546, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III

Salzburg, 5020, Austria

Location

Medical University Vienna

Vienna, 1190, Austria

Location

University Hospital Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitatsklinikum Jena

Jena, 7747, Germany

Location

Universitatsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Soroka

Beersheba, 84101, Israel

Location

Hadassah Medical Center

Jerusalem, 91200, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Pratia MCM Krakow

Krakow, Malopolska, 30-510, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Pratia Onkologia Katowice

Katowice, 40-519, Poland

Location

Copernicus Memorial Hospital

Lodz, 93-513, Poland

Location

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

Warsaw, 02781, Poland

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008.0, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Institut Catala dOncologia (ICO Hospitalet)

Barcelona, 08908, Spain

Location

MD Anderson Cancer Center- Madrid

Madrid, 28033, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 11, 2016
• Study Start: January 11, 2016
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (5); PL (5); ES (11); IL (4); DE (3); AU (2)