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

ClinicalTrials.gov Identifier: NCT02452268

Novartis Reference Number: CNIZ985X2102J

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Metastatic and Advanced Solid Tumors
Phase 
Phase 1
Overall status 
Active, not recruiting
Enrollment count 
74 participants
Start date 
May 08, 2017
Completion date 
Jan 11, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
NIZ985
Subcutaneous administration of hetIL-15 three times a week for two consecutive weeks
Drug
PDR001
• PDR001 is a human monoclonal antibody (MAb) administered day 1 of each cycle

Eligibility Criteria

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.

Study Locations

United States
National Cancer Institute National Cancer Institute
-
Bethesda, 20892
Maryland
United States
Washington University School of Medicine SC
-
Saint Louis, 63110
Missouri
United States
The Ohio State University Comprehensive Cancer Center
-
Columbus, 43212
Ohio
United States
Providence Portland Medical Center SC
-
Portland, 97123
Oregon
United States
Huntsman Cancer Institute
-
Salt Lake City, 84112
Utah
United States
Seattle Cancer Care Alliance
-
Seattle, 98105
Washington
United States
University of Wisconsin
-
Madison, 53792
Wisconsin
United States

Have a question?

Call 1-999-669-6682 or email [email protected]