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JOURNAL ONKOLOGIE – STUDIE

Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

Rekrutierend

NCT-Nummer:
NCT04903197

Studienbeginn:
Januar 2022

Letztes Update:
25.03.2024

Wirkstoff:
VAY736, Lenalidomide

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Novartis Pharmaceuticals

Collaborator:
Bristol-Myers Squibb

Studienleiter

Novartis Institutes of Biomedical Research
Study Director
Novartis Institutes of Biomedical Research

Kontakt

Studienlocations
(3 von 20)

Novartis Investigative Site
37075 Gottingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
City Of Hope National Med Ctr
91010 Duarte
United StatesZurückgezogen» Google-Maps
The Ohio State University James Cancer Hospital &
43210 Columbus
United StatesZurückgezogen» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesZurückgezogen» Google-Maps
Novartis Investigative Site
3004 Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
20089 Rozzano
ItalyAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
135 8550 Koto ku
JapanAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
990 9585 Yamagata
JapanAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
119228 Singapore
SingaporeRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The primary objective of the study is to evaluate the safety and tolerability in patients

with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of VAY736

single agent and in combination with other anti-cancer therapies.

This is a phase I/Ib, multi-center, open-label study with multiple treatment arms in an

adaptive study design. The study is comprised of a dose escalation part and dose expansion

part.

In dose escalation, the investigational drug VAY736 will be explored alone or in combination

with partner therapies. Increasing doses of VAY736 alone or in combination will be given to

small groups of patients to identify the MTD/RD in patients with NHL. In dose expansion, some

or all the treatments from dose escalation will be tested at the recommended doses in

patients with NHL. Combination partners may be added in the future by protocol amendment. The

study is expected to be approximately 4 years in duration (from enrollment of first patient

to discontinuation of last patient).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all

subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle

cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must

have confirmed diagnosis of relapsed/refractory DLBCL.

- Received and failed or be intolerant to standard of care therapy (at least two prior

lines, including an anti-CD20 therapy for NHL)

- Must have measurable disease and ECOG of 0 to 2

Exclusion Criteria:

- Baseline laboratory results outside of protocol defined ranges

- Patients with primary CNS lymphoma

- History of hypersensitivity to VAY736 or any drugs in similar chemical classes (e.g.

monoclonal antibodies)

- Impaired cardiac function or clinically significant cardiac disease

- History of or current interstitial lung disease or pneumonitis grade 2 or higher

- HIV infection

- Active hepatitis C infection and/or hepatitis B infection

- Pregnant or nursing (lactating) women

- Women of child-bearing potential unless they are using highly effective methods of

contraception

Other Inclusion/Exclusion criteria may apply

Studien-Rationale

Primary outcome:

1. Incidence and nature of dose limiting toxicities (DLTs) (Time Frame - 28 days (first cycle of treatment)):
Safety and tolerability

2. Incidence of Adverse events (AEs) and serious adverse events (SAEs) (Time Frame - 4 years):
Incidence of AEs and SAEs is defined as number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.

3. Number of patients with dose interruptions and dose reductions (Time Frame - 4 years):
Safety and tolerability

4. Dose intensity (Time Frame - 4 years):
Safety and tolerability

Secondary outcome:

1. Overall response rate (ORR) (Time Frame - 4 years):
Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)

2. Best overall response (BOR) rate (Time Frame - 4 years):
Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)

3. Area under curve (AUC) for VAY736 and combination partners (Time Frame - 4 years):
PK parameters will be derived from serum concentrations

4. Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners (Time Frame - 4 years):
PK parameters will be derived from serum concentrations

5. Change from baseline in anti-drug antibodies (ADA) (Time Frame - Baseline, 4 years):
Blood samples will be collected to detect change in levels of antibodies to VAY736

Studien-Arme

  • Experimental: Arm 1A
    VAY736 single agent dose escalation in patients with NHL subtypes of diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL)
  • Experimental: Arm 1B
    VAY736 single agent dose expansion in patients with DLBCL
  • Experimental: Arm 2A
    VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). Enrollment has been halted in this arm.
  • Experimental: Arm 2B
    VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm will not be conducted.

Geprüfte Regime

  • VAY736 (ianalumab):
    VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.
  • lenalidomide:
    Immune-modulatory agent that enhances activation of NK cells.

Quelle: ClinicalTrials.gov


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