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

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

Spots Global Cancer Trial Database for in escalation: all patients with solid tumors and lymphoma