A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.
- Trial number:
- NCT03549000
- Trial phase:
- 1
- Study type:
- Immunotherapy
- Overall status:
- Terminated
Study start date
July, 2018
Scientific title
A Phase I/Ib, Open-label, Multi-center, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies.
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
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.
Study design
Primary purpose:
Treatment, Allocation:
Non-Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
Non-small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer Microsatellite Stable (MSS), Ovarian Cancer, Renal Cell Carcinoma (RCC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Other study ID numbers
CNZV930X2101; 2018-000153-51
Choose trial site (10)
H Lee Moffitt Cancer Center and Research Institute Inc
3011 Holly Dr, Tampa, FL 33612, USA
University of Texas MD Anderson Cancer Center MD Anderson PSC
1515 Holcombe Blvd, Houston, TX 77030, USA
Novartis Investigative Site
Melbourne VIC 3000, Australia
Novartis Investigative Site
Toronto, ON M5G 1Z6, Canada
Novartis Investigative Site
385 Boul. Bouchard, Dorval, QC H9S 1A9, Canada
Novartis Investigative Site
104-0045, Japan
National Cancer Centre Singapore
20 Pasir Panjang Rd, #10-25/28 Mapletree Business City, Singapore 117439
Novartis Investigative Site
Plaça de la Porta de la Mar, 6, 46004 València, Valencia, Spain
Novartis Investigative Site
C. de Serrano Galvache, 56, 28033 Madrid, Spain
Novartis Investigative Site
Sutton SM2 5PT, UK