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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005881-32 | EudraCT Number |
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Business decision and not due to any safety or tolerability concerns.
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The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.
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 was explored alone or in combination with lenalidomide. Increasing doses of VAY736 alone or in combination were given to small groups of patients to identify the maximum tolerated dose/recommended dose (MTD/RD) in patients with NHL. In dose expansion, some or all the treatments from dose escalation could be tested at the recommended doses in patients with NHL. The study was expected to last approximately 4 years (from the enrollment of the first patient to the discontinuation of the last patient), but it was terminated early due to a business decision, not because of any safety or tolerability concerns. Consequently, the dose expansion part was not conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1A | Experimental | 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) |
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| Arm 1B | Experimental | VAY736 single agent dose expansion in patients with DLBCL. This arm was not conducted. |
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| Arm 2A | Experimental | VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). |
|
| Arm 2B | Experimental | VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm was not conducted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAY736 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of dose limiting toxicities (DLTs) | Safety and tolerability | 28 days (first cycle of treatment) |
| Incidence of Adverse events (AEs) and serious adverse events (SAEs) | 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. | 4 years |
| Number of patients with dose interruptions and dose reductions | Safety and tolerability | 4 years |
| Dose intensity | Safety and tolerability | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans) | 4 years |
| Best overall response (BOR) rate | Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans) |
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Inclusion Criteria:
Exclusion Criteria:
Other Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Institutes of Biomedical Research | Novartis Institutes of Biomedical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Melbourne | Victoria | 3004 | Australia | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| CVAY736J12101 Clinical Trial Results | View source |
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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|
| lenalidomide | Drug | Immune-modulatory agent that enhances activation of NK cells. |
|
| 4 years |
| Area under curve (AUC) for VAY736 and combination partners | PK parameters will be derived from serum concentrations | 4 years |
| Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners | PK parameters will be derived from serum concentrations | 4 years |
| Change from baseline in anti-drug antibodies (ADA) | Blood samples will be collected to detect change in levels of antibodies to VAY736 | Baseline, 4 years |
| Shanghai |
| 200032 |
| China |
| Novartis Investigative Site | Tianjin | 300020 | China |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Yamagata | Yamagata | 990 9585 | Japan |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| C000656267 | ianalumab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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