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

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

ClinicalTrials.gov Identifier: NCT02947165

Novartis Reference Number: CNIS793X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Breast Cancer
Lung Cancer
Hepatocellular Cancer
Colorectal Cancer
Pancreatic Cancer
Renal Cancer
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
220 participants
Start date 
Apr 25, 2017
Completion date 
Jul 06, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
NIS793
Anti-TGF beta antibody tested on a Q3W regimen or alternative Q2W regimen.
Drug
PDR001
Anti-PD-1 antibody tested on a Q3W regimen or alternative Q4W regimen.

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Locations

United States
Sarah Cannon Research Institute SC
Recruiting
Nashville, 37203
Tennessee
United States
Huntsman Cancer Institute SC
Recruiting
Salt Lake City, 84112
Utah
United States
Austria
Novartis Investigative Site
Recruiting
Salzburg, 5020
-
Austria
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 2C1
Ontario
Canada
Germany
Novartis Investigative Site
Completed
Ulm, 89081
-
Germany
Novartis Investigative Site
Active, not recruiting
Wuerzburg, 97080
-
Germany
Hong Kong
Novartis Investigative Site
Active, not recruiting
Hong Kong,
-
Hong Kong
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Active, not recruiting
Kashiwa, 277 8577
Chiba
Japan
Switzerland
Novartis Investigative Site
Active, not recruiting
St. Gallen, 9007
-
Switzerland
Taiwan
Novartis Investigative Site
Active, not recruiting
Taipei, 10002
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]