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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02651662

Studienbeginn:
Januar 2016

Letztes Update:
18.04.2024

Wirkstoff:
Cemiplimab, Odronextamab

Indikation (Clinical Trials):
Lymphoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Regeneron Pharmaceuticals

Collaborator:
-

Studienleiter

Clinical Trial Management
Study Director
Regeneron Pharmaceuticals

Kontakt

Clinical Trials Administrator
Kontakt:
E-Mail: clinicaltrials@regeneron.com» Kontaktdaten anzeigen

Studienlocations
(3 von 9)

Regeneron Research Facility
69120 Heidelberg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps

Regeneron Research Facility
21287 Baltimore
United StatesAktiv, nicht rekrutierend» Google-Maps

Regeneron Research Facility
02215 Boston
United StatesRekrutierend» Google-Maps

Regeneron Research Facility
08035 Barcelona
SpainRekrutierend» Google-Maps

Regeneron Research Facility
28033 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps

Regeneron Research Facility
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps

Regeneron Research Facility
28041 Madrid
SpainRekrutierend» Google-Maps

Regeneron Research Facility
28222 Majadahonda
SpainAktiv, nicht rekrutierend» Google-Maps

Regeneron Research Facility
37007 Salamanca
SpainAktiv, nicht rekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

1. 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.

2. 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]).

3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

4. Adequate bone marrow and hepatic function, as defined in the protocol

5. Willing and able to comply with clinic visits and study-related procedures

6. Provide signed informed consent

Key Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement

by non-primary CNS NHL

2. History of or current relevant CNS pathology, as described in the protocol

3. 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)

4. Prior therapies, as described in the protocol

5. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or

hepatitis C infection or other uncontrolled infection

6. Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase

chain reaction (PCR) assay until the infection is well controlled.

7. Known hypersensitivity to both allopurinol and rasburicase

8. Pregnant or breastfeeding women

9. 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

10. Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage

activation syndrome (MAS)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Studien-Rationale

Primary outcome:

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 outcome:

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)

Studien-Arme

Experimental: Dose escalation phase
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.
Experimental: Dose expansion phase
RP2D administration of the combination treatment.

Geprüfte Regime

cemiplimab (REGN2810 / Libtayo / ):
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
odronextamab (REGN1979):
Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.

Quelle: ClinicalTrials.gov

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