Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Lenalidomide

Daratumumab

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

ANV419 administered by intravenous (IV) infusion

ANV419

Lenalidomide and dexamethasone administered orally

Lenalidomide with low-dose dexamethasone

Daratumumab administered by subcutaneous injection

Eduard Gasal, MD

The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab.

The purpose of this multi-site, open-label, Phase 1 adaptive design study is to evaluate the safety, tolerability and preliminary efficacy of ANV419 as a monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab in patients aged 18 years or older with with relapsed or refractory Multiple Myeloma.

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)

Anaveon AG

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ipilimumab administered by intravenous (IV) infusion

Claudia Schusterbauer, MD

The purpose of this study is to test the safety and efficacy of ANV419 (single agent) and in combination with ipilimumab in patients with relapsed/refractory advanced solid tumors.

The purpose of this First-in-Human, open-label, dose escalation study is to assess the initial safety and efficacy profile of ANV419 intravenous infusion alone and in combination with ipilimumab in patients with advanced solid tumours. It will evaluate the safety and tolerability of ANV419 alone and in combination with ipilimumab and, the safest and best dose of ANV419 when used alone or in combination.

A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer.

ANV419 First in Human Study Phase 1: Open-label, Dose Escalation Study of ANV419 as Single Agent and in Combination With Ipilimumab in Patients With Relapsed/Refractory Advanced Solid Tumors

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients have excisional biopsy/surgical resection of tumor lesion(s) (tumor collection) and TILs are expanded from this lesion/these lesions (TIL expansion).

The transplant product will be produced in the Good Manufacturing Practice (GMP) facility of the University Hospital in Basel. TIL transfer to patient and first administration of ANV419 at day 0.

The study uses a personalized IMP (investigational medicinal product), i.e. TIL product in combination with ANV419.

Day 0: Autologous TIL: (minimum 5 x 10\^9 and up to 2x 10\^11 lymphocytes) administered intravenously over 20 to 30 minutes.

Day 0: Intravenous treatment with ANV419 at 243 μg/kg 2 hours after the TIL infusion. Actual body weight will be used to calculate the dose of ANV419.

Day14: Intravenous treatment with ANV419 at 243 μg/kg. Actual body weight will be used to calculate the dose of ANV419.

Combination of Tumor-infiltrating lymphocyte transfer with ANV419

Heinz Läubli, Prof.

David König, Dr. med.

Benjamin Kasenda, PD Dr.

In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma

In brief, this trial consists of four study periods: screening, pre-treatment, treatment, and observational follow-up.

In the screening period, patients are screened for trial eligibility. In the pre-treatment period, patients have excisional biopsy/surgical resection of tumor lesion(s) (tumor collection) and TILs are expanded from this lesion/these lesions (TIL expansion). Patients are permitted to receive bridging therapy outside of the study protocol.

In the treatment period, patients have TIL-ACT. TIL-ACT includes a detailed procedure of preparative chemotherapy, followed by transfer of the TIL product, followed by in-vivo TIL expansion with ANV419 (2 doses). TIL transfer is defined as day 0 in the study protocol. Patients have an End of Treatment visit (14 days after the last study treatment), a safety follow-up (30 days after the last study treatment) and an efficacy follow up, which is the End of Study visit (day +90).

Thereafter, patients will transfer to observational follow-up, which is conducted every 3 months until 1 year after TIL transfer.

Patients who terminate the study prematurely during any of the treatment period due to e.g., disease progression, toxicity, patient wish, etc. will also transfer to observational follow-up.

The regimen (TIL-ACT with ANV419) has not been tested. Review by the IDSMB (independent data safety monitoring board) will be performed after 3 patients (safety check).

ACT-TIL and ANV419 for Advanced Melanoma.

A Phase I Trial of Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes and ANV419 in Patients With Advanced Melanoma. The BaseTIL-03M Trial

Incidence of adverse events (%) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419

Frequency of adverse events (number) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419

Severity of adverse events (CTCAE v5.0 criteria) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419.

CTCAE (Common Terminology Criteria for Adverse Events): Grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal.

ORR is defined as the proportion of patients with a best overall response of partial response or better (assessed by the local investigators)

DOR is defined as the time from the first documented response and the date of the first documented tumor progression, death, or the last tumor assessment that occurred before subsequent therapy. DOR time for responders who have not progressed or died will be censored at the time of last tumor assessment

The progression-free survival (PFS) is defined as the time from registration to objective tumor progression (determined by local investigators), or death due to any cause, whichever occurred first. PFS time for patients who have not progressed or died will be censored at the time of the last tumor assessment

OS is defined as the time from registration to the date of death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)	NCT05641324	Multiple Myelom... Relapsed Cancer Refractory Mult... Adult Disease Hematologic Dis...	ANV419 Lenalidomide wi... Daratumumab	18 Years -	Anaveon AG
A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer.	NCT04855929	Advanced Solid ... Adult Disease Lung Cancer	ANV419 Ipilimumab	18 Years -	Anaveon AG
ACT-TIL and ANV419 for Advanced Melanoma.	NCT05869539	Advanced Melano...	Combination of ...	18 Years -	University Hospital, Basel, Switzerland
ACT-TIL and ANV419 for Advanced Melanoma.	NCT05869539	Advanced Melano...	Combination of ...	18 Years -	University Hospital, Basel, Switzerland
A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer.	NCT04855929	Advanced Solid ... Adult Disease Lung Cancer	ANV419 Ipilimumab	18 Years -	Anaveon AG

Spots Global Cancer Trial Database for anv419

Every month we try and update this database with for anv419 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for anv419

Every month we try and update this database with for anv419 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for anv419 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.