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



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:April 25, 2017
End Date:April 13, 2021
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies

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


Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures.

2. Patient (male or female) ≥ 18 years of age.

3. 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.

4. 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.

5. ECOG Performance Status ≤ 2.

6. 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.

Exclusion Criteria:

1. History of severe hypersensitivity reactions to study treatment ingredients or other
monoclonal antibodies and components of study drug.

2. 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.

3. HIV infection.

4. Active HBV or HCV infection.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
3
sites
Salt Lake City, Utah 84103
Principal Investigator: Ignacio Garrido Laguna
Phone: 801-213-4217
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Nashville, Tennessee 37205
Principal Investigator: Todd M. Bauer
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Salzburg,
Click here to add this to my saved trials