Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Melanoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

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

Lymphosarcoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Immunomodulating Agents

Spartalizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Single agent arm. NIZ985 is administered as a single agent (subjects may be treated with the NIZ985-Spartalizumab combination after their first disease re-evaluation)

Combination arm. NIZ985 and Spartalizumab combination is administered starting at Cycle 1 Day 1 in dose escalation. NIZ985 and tislelizumab combination is administered starting at Cycle 1 Day 1 in dose expansion.

NIZ985

The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic profiles of NIZ985 as a single agent and in combination with spartalizumab or tislelizumab and identified preliminary anti-tumor activity.

This was a phase I/Ib, open-label, global, multi-center study of subcutaneously administered NIZ985 alone and in combination with a PD-1 inhibitor in patients with advanced solid tumors and lymphoma who had progressed after obtaining a previous response to anti-PD-1/ CPI therapy at any time prior to enrollment. Previous response was defined as a radiographic complete response (CR) or a partial response (PR). Patients with stable disease (SD) lasting ≥ 6 months could also be included if the most recent regimen included CPI. The study consisted of two parts, dose escalation and dose expansion. Two separate arms were examined during the escalation portion: 1) evaluation of NIZ985 as a single agent. Spartalizumab could be added at the time of the first disease re-evaluation and 2) administration of NIZ985 and spartalizumab as a combination starting from C1D1. In dose expansion, NIZ985 was administered in combination with tislelizumab.

A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab

A Phase I/Ib Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL-15/sIL-15Rα)) in Combination With Spartalizumab in Patients With Check Point Inhibitor (CPI) Relapsed Advanced Solid Tumors and Lymphoma

Incidence of DLTs in Cycle 1 (28 days) in escalation and expansion

AEs and SAEs including changes in laboratory parameters, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs for all patients from escalation and expansion

Number of dose interruptions and dose reductions of NIZ985, spartalizumab and tislelizumab.

Dose intensity as a ratio of cumulative dose received during duration of exposure over duration of exposure for NIZ985, spartalizumab and tislelizumab.

Measurement of serum concentrations of NIZ985, spartalizumab, and tislelizumab

Measurement of serum antidrug antibodies (ADA) to NIZ985, spartalizumab, and tislelizumab at baseline and on treatment

Novartis Pharmaceuticals

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Antibodies

Antibodies, Monoclonal

Immunoglobulins

* Single treatment arm, dose escalation administered subcutaneously (SC) on MWF for 2 consecutive weeks.
* Cycle length 28 days.
* Occurrence of a dose-limiting toxicity (DLT) leads to the expansion to 6 subjects.
* MTD is the dose prior to the dose level where ≥ 2/6 subjects have a DLT.
* Following identification of the MTD / RDE, dose expansion will follow.

* The phase Ib dose escalation portion of the study will consist of a fixed dose (400 mg, IV infusion, Q4W) of PDR001 and escalating doses of NIZ985 (hetIL-15) to evaluate safety, tolerability and determine the MTD and/or RDE of the combination to be used in expansion cohorts.
* On days when PDR001 and NIZ985 are administered on the same day, PDR001 will be administered first. NIZ985 will be administered after the PDR001 infusion has been completed.
* Information on the preparation and administration of PDR001 is found in the PDR001 pharmacy manual.

Subcutaneous administration of hetIL-15 three times a week for two consecutive weeks

• PDR001 is a human monoclonal antibody (MAb) administered day 1 of each cycle

PDR001

Phase I/Ib multicenter clinical trial. Single agent dose escalation of NIZ985 followed by expansion. Second escalation of NIZ985 in combination with PDR001 followed by expansion

A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers

A Phase 1 Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL15/sIL-15Ra)) Alone and in Combination With PDR001 in Adults With Metastatic Cancers

Best overall response (BOR) per RECIST and irRC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab	NCT04261439	In Escalation: ... In Expansion: M...	NIZ985 Spartalizumab Tislelizumab	18 Years -	Novartis
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab	NCT04261439	In Escalation: ... In Expansion: M...	NIZ985 Spartalizumab Tislelizumab	18 Years -	Novartis
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab	NCT04261439	In Escalation: ... In Expansion: M...	NIZ985 Spartalizumab Tislelizumab	18 Years -	Novartis
A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers	NCT02452268	Metastatic and ...	NIZ985 PDR001	18 Years -	Novartis

Spots Global Cancer Trial Database for niz985

Every month we try and update this database with for niz985 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 niz985

Every month we try and update this database with for niz985 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 niz985 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.