- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2018-07-18
2022-10-17
2022-10-17
127
NCT03549000
Novartis
Novartis
INTERVENTIONAL
A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.
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
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-25 | N/A | 2024-12-09 |
2018-05-25 | N/A | 2024-12-13 |
2018-06-07 | N/A | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: NZV930 Monotherapy Single Agent NZV930 | OTHER: NZV930
|
| EXPERIMENTAL: NZV930 with PDR001 Doublet Therapy Combination of NZV930 with PDR001 | OTHER: NZV930
OTHER: PDR001
|
| EXPERIMENTAL: NZV930 with NIR178 Doublet Therapy Combination of NZV930 with NIR178 | OTHER: NZV930
DRUG: NIR178
|
| EXPERIMENTAL: NZV930 with NIR178 & PDR001 Triplet Therapy Combination of NZV930 with NIR178 and PDR001 | OTHER: NZV930
OTHER: PDR001
DRUG: NIR178
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability of the NZV930 in combination with PDR001 and/or NIR178 | Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs, and ECGs Dose limiting toxicity in cycle 1 (28 days) for single agent NZV930 and NZV930 in combination with PDR001 and/or NIR178 during dose escalation phase only Tolerability: dose interruptions Tolerability: dose reductions Tolerability: dose intensity | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Defined as the proportion of patients with best overall response of CR or PR | 3 years |
| Clinical Benefit Rate (CBR) | Defined as the proportion of patients with best overall response of CR, PR or SD >= 16 weeks | 3 years |
| Progression Free Survival (PFS) | Defined as the time from the date of start of treatment to the date of the event defined as first documented progression or death due to any cause | 3 years |
| Serum concentration vs. time profiles of NZV930 (free drug) and PDR001. | Serum concentration vs. time profiles of NZV930 (free drug) and PDR001. | 3 years |
| Plasma concentration vs. time profiles for NIR178 and derived PK parameters | Concentration time profile of NIR178 and its metabolites | 3 years |
| To assess the immunogenicity of NZV930 and PDR001 | Presence and titer of anti-drug antibodies, anti-NZV930 and anti-PDR001 in (patients receiving combination with PDR001). | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
