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Completed

NCT Number: NCT02651662

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 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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Treatment and study plan

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.

Other names: REGN2810, Libtayo

Odronextamab

Drug

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

Other names: REGN1979

Primary outcomes

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

    Time frame: Up to 28 days

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

    Time frame: Up to 18 months

  3. Severity of TEAEs of cemiplimab in combination with odronextamab

    Time frame: Up to 18 months

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

    Time frame: Up to 18 months

  5. Severity of AESIs of cemiplimab in combination with odronextamab

    Time frame: Up to 18 months

Secondary outcomes

  1. Odronextamab and cemiplimab concentrations in serum

    Time frame: Up to 18 months

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

    Time frame: Up to 18 months

  3. Titer of ADAs to odronextamab and cemiplimab over time

    Time frame: Up to 18 months

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

    Time frame: Up to 18 months

  5. Titer of Nabs to odronextamab and cemiplimab over time

    Time frame: Up to 18 months

  6. Overall response rate as assessed by investigator

    Time frame: Up to 18 months

  7. Complete response (CR) rate as assessed by investigator

    Time frame: Up to 18 months

  8. Duration of response as assessed by investigator

    Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2016
Registry last updated
Jun 2, 2026

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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