A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With… (NCT03549000) | Clinical Trial Compass
TerminatedPhase 1
A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.
Stopped: After review of data which showed low likelihood of efficacy in these patients Novartis decided to terminate the trial early. Termination was not safety related
United States, Australia, Canada127 participantsStarted 2018-07-18
Plain-language summary
The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Adult men \& women ≥ 18 years of age Histologically confirmed advanced malignancies with documented progression following standard therapy, or for whom, in the opinion of the investigator, no appropriate standard therapy exists.
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:
Symptomatic or uncontrolled Brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
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 e…
What they're measuring
1
Number of participants with adverse events as a measure of safety and tolerability of the NZV930 in combination with PDR001 and/or NIR178