Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

Completed · Phase 1

Conditions studied: Breast Cancer, Lung Cancer, Hepatocellular Cancer, Colorectal Cancer, Pancreatic Cancer, Renal Cancer

In brief

To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.

Key facts

Study ID

NCT02947165

Run by

Novartis Pharmaceuticals

People needed

120

Starts

2017-04-25

Expected to finish

2021-06-18

Last updated by the study team

2022-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent must be obtained prior to any screening procedures.
• Patient (male or female) ≥ 18 years of age.
• Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
• Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC resistant to anti-PD-1/PD-L1; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic; Group 6 ccRCC resistant to anti-PD-1/PD-L1.
• Resistance to anti-PD-1/PD-L1 therapy is defined as: Documented progressive disease occurring while on/or within 6 months after anti-PD-1 and/or anti-PD-L1 agent (single or combination) received as the last therapy prior to enrollment.
• ECOG Performance Status ≤ 2.
• Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.

You may not qualify if…

• History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug.
• Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• HIV infection.
• Active HBV or HCV infection.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Sarah Cannon Research Institute SC — Nashville, Tennessee, United States
• Huntsman Cancer Institute SC — Salt Lake City, Utah, United States
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Kashiwa, Chiba, Japan
• Novartis Investigative Site — Sankt Gallen, Switzerland
• Novartis Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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