Spots Global Cancer Trial Database for A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab

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Trial Identification

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

Official Title: 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

Study ID: NCT04261439

Conditions

In Escalation: All Patients With Solid Tumors and Lymphoma

In Expansion: Melanoma, Non-small Cell Lung Cancer

Interventions

NIZ985

Spartalizumab

Tislelizumab

Study Description

Brief Summary: 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.

Detailed Description: 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.