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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04903197




Registration number
NCT04903197
Ethics application status
Date submitted
25/05/2021
Date registered
26/05/2021

Titles & IDs
Public title
Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
Scientific title
A Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)
Secondary ID [1] 0 0
2020-005881-32
Secondary ID [2] 0 0
CVAY736J12101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VAY736
Treatment: Drugs - lenalidomide

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.


Treatment: Drugs: VAY736
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.

Treatment: Drugs: lenalidomide
Immune-modulatory agent that enhances activation of NK cells.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and nature of dose limiting toxicities (DLTs)
Timepoint [1] 0 0
28 days (first cycle of treatment)
Primary outcome [2] 0 0
Incidence of Adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
4 years
Primary outcome [3] 0 0
Number of patients with dose interruptions and dose reductions
Timepoint [3] 0 0
4 years
Primary outcome [4] 0 0
Dose intensity
Timepoint [4] 0 0
4 years
Secondary outcome [1] 0 0
Overall response rate (ORR)
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Best overall response (BOR) rate
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Area under curve (AUC) for VAY736 and combination partners
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners
Timepoint [4] 0 0
4 years
Secondary outcome [5] 0 0
Change from baseline in anti-drug antibodies (ADA)
Timepoint [5] 0 0
Baseline, 4 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shanghai
Country [2] 0 0
China
State/province [2] 0 0
Tianjin
Country [3] 0 0
Germany
State/province [3] 0 0
Leipzig
Country [4] 0 0
Italy
State/province [4] 0 0
BS
Country [5] 0 0
Italy
State/province [5] 0 0
MI
Country [6] 0 0
Japan
State/province [6] 0 0
Yamagata
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Institutes of Biomedical Research
Address 0 0
Novartis Institutes of Biomedical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04903197