A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02452268 |
Recruitment Status :
Completed
First Posted : May 22, 2015
Last Update Posted : March 23, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic and Advanced Solid Tumors | Drug: NIZ985 Drug: PDR001 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 8, 2017 |
Actual Primary Completion Date : | March 7, 2022 |
Actual Study Completion Date : | March 7, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: NIZ985
|
Drug: NIZ985
Subcutaneous administration of hetIL-15 three times a week for two consecutive weeks
Other Name: IL-15/sIL-15Ra, heterodimeric IL-15 |
Experimental: NIZ985 + PDR001
|
Drug: PDR001
• PDR001 is a human monoclonal antibody (MAb) administered day 1 of each cycle |
- Assess the dose-limiting toxicity of the single agent NIZ985 and the combination of PDR001 [ Time Frame: 28 days ]
- Determine the maximum tolerated dose (MTD) of hetIL-15 as determined by DLTs during Cycle 1. [ Time Frame: 28 days ]
- Determine the pharmacokinetic (PK) profile of hetIL-15, including T½ [ Time Frame: 28 days ]
- Determine the pharmacokinetic (PK) profile of hetIL-15, including Cmax. [ Time Frame: 28 Days ]
- Determine the preliminary anti-tumor activity of hetIL-15 [ Time Frame: 8 weeks ]Best overall response (BOR) per RECIST and irRC

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:
-
Histologically confirmed solid tumor malignancy that is metastatic or unresectable and have progressed on at least 1 prior therapy and for whom standard curative or palliative measures do not exist or are associated with minimal subject survival benefit.
Evaluable or measurable disease, defined as by Response Evaluation Criteria in Solid Tumors (RECIST).
- Recovered to ≤ grade 1 NCI CTCAE version 4.0 from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks earlier.
- Subjects on bisphosphonates for any cancer or on hormone therapy for prostate cancer may continue this therapy. However, subjects with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy producing castrate levels of testosterone.
- Age ≥18 years.
- ECOG performance status ≤1 (Karnofsky ≥70%).
-
Normal organ and marrow function:
- leukocytes ≥3,000/mcL
- absolute neutrophil count (ANC) ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- AST/ALT ≤2.5 × ULN
- creatinine <1.5 × institutional ULN OR
- creatinine clearance ≥60 mL/min/1.73 m2 for subjects with serum creatinine levels >1.5 × higher than ULN.
- DLCO/VA and FEV1 ≥ 50% of predicted on PFTs.
- Subjects with inactive central nervous system (CNS) metastasis are eligible..
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during the treatment portion of the study and for 4 months after completion of hetIL-15 administration.
- Able to provide written informed consent.
- Life expectancy > 3 months.
Exclusion Criteria:
- Prior IL-15 treatment or cytotoxic therapy, immunotherapy, radiotherapy, major surgery, antitumor vaccines or monoclonal antibodies in the 4 weeks prior or for checkpoint inhibitors such as anti-CTLA-4 or anti PD1/PD-L1 or nitrosoureas or mitomycin C for 6 weeks prior to C1D1.
- Primary brain cancers or active CNS metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to hetIL-15.
- Concurrent anticancer therapy (including other investigational agents) with the exception of hormone therapy for prostate cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cognitive impairment, active substance abuse, or psychiatric illness/social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements.
- HIV positive patients.
- Positive hepatitis B or C serology.
- History of severe asthma or absolute requirement for chronic inhaled corticosteroid medications.
- History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-CTLA-4) therapy that has been completely resolved for more than 4 weeks prior to C1D1.

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): NCT02452268
United States, Maryland | |
National Cancer Institute National Cancer Institute | |
Bethesda, Maryland, United States, 20892 | |
United States, Missouri | |
Washington University School of Medicine SC | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
The Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43212 | |
United States, Oregon | |
Providence Portland Medical Center SC | |
Portland, Oregon, United States, 97123 | |
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98105 | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02452268 |
Other Study ID Numbers: |
CNIZ985X2102J NIZ985X2102J ( Other Identifier: Novartis ) |
First Posted: | May 22, 2015 Key Record Dates |
Last Update Posted: | March 23, 2022 |
Last Verified: | March 2022 |
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 |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |
Spartalizumab Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |