Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT04903197 |
Recruitment Status :
Recruiting
First Posted : May 26, 2021
Last Update Posted : March 25, 2024
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Condition or disease | Intervention/treatment | Phase |
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Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma | Drug: VAY736 Drug: lenalidomide | Phase 1 |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Actual Study Start Date : | January 24, 2022 |
Estimated Primary Completion Date : | October 30, 2026 |
Estimated Study Completion Date : | October 30, 2026 |
Arm | Intervention/treatment |
---|---|
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)
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Drug: 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.
Other Name: ianalumab |
Experimental: Arm 1B
VAY736 single agent dose expansion in patients with DLBCL
|
Drug: 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.
Other Name: ianalumab |
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.
|
Drug: 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.
Other Name: ianalumab Drug: lenalidomide Immune-modulatory agent that enhances activation of NK cells. |
Experimental: Arm 2B
VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm will not be conducted.
|
Drug: 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.
Other Name: ianalumab Drug: lenalidomide Immune-modulatory agent that enhances activation of NK cells. |
- Incidence and nature of dose limiting toxicities (DLTs) [ Time Frame: 28 days (first cycle of treatment) ]Safety and tolerability
- 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.
- Number of patients with dose interruptions and dose reductions [ Time Frame: 4 years ]Safety and tolerability
- Dose intensity [ Time Frame: 4 years ]Safety and tolerability
- Overall response rate (ORR) [ Time Frame: 4 years ]Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)
- Best overall response (BOR) rate [ Time Frame: 4 years ]Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)
- Area under curve (AUC) for VAY736 and combination partners [ Time Frame: 4 years ]PK parameters will be derived from serum concentrations
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04903197
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |
United States, California | |
City Of Hope National Med Ctr | Withdrawn |
Duarte, California, United States, 91010 | |
United States, Ohio | |
The Ohio State University James Cancer Hospital & | Withdrawn |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
MD Anderson Cancer Center | Withdrawn |
Houston, Texas, United States, 77030 | |
Australia, Victoria | |
Novartis Investigative Site | Active, not recruiting |
Melbourne, Victoria, Australia, 3004 | |
China, Jiangsu | |
Novartis Investigative Site | Recruiting |
Nanjing, Jiangsu, China, 210029 | |
China | |
Novartis Investigative Site | Recruiting |
Shanghai, China, 200032 | |
Novartis Investigative Site | Recruiting |
Tianjin, China, 300020 | |
Germany | |
Novartis Investigative Site | Recruiting |
Gottingen, Germany, 37075 | |
Novartis Investigative Site | Recruiting |
Koeln, Germany, 50937 | |
Novartis Investigative Site | Recruiting |
Leipzig, Germany, 04103 | |
Italy | |
Novartis Investigative Site | Recruiting |
Brescia, BS, Italy, 25123 | |
Novartis Investigative Site | Withdrawn |
Milano, MI, Italy, 20133 | |
Novartis Investigative Site | Active, not recruiting |
Rozzano, MI, Italy, 20089 | |
Japan | |
Novartis Investigative Site | Active, not recruiting |
Koto ku, Tokyo, Japan, 135 8550 | |
Novartis Investigative Site | Active, not recruiting |
Yamagata, Japan, 990 9585 | |
Korea, Republic of | |
Novartis Investigative Site | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Novartis Investigative Site | Recruiting |
Seoul, Korea, Republic of, 05505 | |
Singapore | |
Novartis Investigative Site | Recruiting |
Singapore, Singapore, 119228 | |
Spain | |
Novartis Investigative Site | Recruiting |
Madrid, Spain, 28034 | |
Novartis Investigative Site | Recruiting |
Madrid, Spain, 28041 |
Study Director: | Novartis Institutes of Biomedical Research | Novartis Institutes of Biomedical Research |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04903197 |
Other Study ID Numbers: |
CVAY736J12101 2020-005881-32 ( EudraCT Number ) |
First Posted: | May 26, 2021 Key Record Dates |
Last Update Posted: | March 25, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
non-Hodgkin lymphoma Diffuse large B cell lymphoma Follicular lymphoma Mantle cell lymphoma Marginal zone lymphoma VAY736 ianalumab |
lenalidomide NHL DLBCL FL MCL MZL |
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lenalidomide Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |