A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.
NCT ID: NCT03549000
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
127 participants
INTERVENTIONAL
2018-07-18
2022-10-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NZV930 Monotherapy
Single Agent NZV930
NZV930
NZV930, Specified dose on specified days, intravenous (IV)
NZV930 with PDR001 Doublet Therapy
Combination of NZV930 with PDR001
NZV930
NZV930, Specified dose on specified days, intravenous (IV)
PDR001
PDR001, Specified dose on specified days, intravenous (IV)
NZV930 with NIR178 Doublet Therapy
Combination of NZV930 with NIR178
NZV930
NZV930, Specified dose on specified days, intravenous (IV)
NIR178
NIR178 Specified dose on specified days, Orally
NZV930 with NIR178 & PDR001 Triplet Therapy
Combination of NZV930 with NIR178 and PDR001
NZV930
NZV930, Specified dose on specified days, intravenous (IV)
PDR001
PDR001, Specified dose on specified days, intravenous (IV)
NIR178
NIR178 Specified dose on specified days, Orally
Interventions
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NZV930
NZV930, Specified dose on specified days, intravenous (IV)
PDR001
PDR001, Specified dose on specified days, intravenous (IV)
NIR178
NIR178 Specified dose on specified days, Orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment.
ECOG performance status 0-2 and in the opinion of the investigator, likely to complete at least 56 days of treatment.
Exclusion Criteria
Patients with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment prior to study entry and at doses of \<10 mg per day prednisolone or equivalent for at least 2 weeks before administration of any study treatment.
Patients who required discontinuation of treatment due to treatment-related toxicities with prior immunotherapy.
Patients previously treated with anti-CD73 treatment and/or adenosine receptor A2a (A2aR) inhibitors.
Active, previously documented, or suspected autoimmune disease within the past 2 years.
Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded. Additionally, patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
History of or current drug-induced interstitial lung disease or pneumonitis grade ≥ 2.
Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following: Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia Patients with corrected QT using the Fridericia's correction (QTcF) \> 470 msec for females or \>450 msec for males, on screening ECG or congenital long QT syndrome Acute myocardial infarction or unstable angina \< 3 months prior to study entry History of stroke or transient ischemic event requiring medical therapy Symptomatic claudication Infection: HIV infection, Active HBV or HCV infection (per institutional guidelines). Patients with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed in the expansion but not in the escalation, Known history of tuberculosis Infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed treatment before screening is initiated.
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 6 weeks is indicated as washout period. For patients receiving anticancer immunotherapies, 4 weeks is indicated as the washout period.
Systemic chronic steroid therapy (≥ 10 mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, nasal, and ophthalmic steroids are allowed
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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H Lee Moffitt Cancer Center and Research Institute Inc
Tampa, Florida, United States
University of Texas MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Sutton, Surrey, United Kingdom
Countries
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Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2018-000153-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNZV930X2101
Identifier Type: -
Identifier Source: org_study_id