Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02947165 |
Recruitment Status :
Completed
First Posted : October 27, 2016
Last Update Posted : January 31, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Lung Cancer Hepatocellular Cancer Colorectal Cancer Pancreatic Cancer Renal Cancer | Drug: NIS793 Drug: PDR001 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies |
Actual Study Start Date : | April 25, 2017 |
Actual Primary Completion Date : | June 18, 2021 |
Actual Study Completion Date : | June 18, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: NIS793 |
Drug: NIS793
Anti-TGF beta antibody tested on a Q3W regimen or alternative Q2W regimen. |
Experimental: NIS793 + PDR001 |
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. |
- Incidence of DLTs, AEs, SAEs and dose reductions / interruptions for NIS793 [ Time Frame: Up to 90 days after end of treatment ]
- Incidence of DLTs, AEs, SAEs and dose reductions/interruptions for NIS793 in combination with PDR001 [ Time Frame: Up to 150 days after end of treatment ]
- Best overall response (BOR) [ Time Frame: 48 months ]Evaluate the anti-tumor activity per RECIST as well as per immune related Response Criteria (irRC) of NIS793 as single agent and in combination with PDR001 every 2 cycles from start of treatment until cycle 9 then every 3 cycles until end of treatment (if applicable).
- Disease control rate (DCR) [ Time Frame: 48 months ]Evaluate the anti-tumor activity per RECIST as well as per immune related Response Criteria (irRC) of NIS793 as single agent and in combination with PDR001every 2 cycles from start of treatment until cycle 9 then every 3 cycles until end of treatment (if applicable).
- Overall response rate (ORR) [ Time Frame: 48 months ]Evaluate the anti-tumor activity per RECIST as well as per immune related Response Criteria (irRC) of NIS793 as single agent and in combination with PDR001 every2 cycles from start of treatment until cycle 9 then every 3 cycles until end of treatment (if applicable).
- Progression free survival (PFS) [ Time Frame: 48 months ]Evaluate the anti-tumor activity per RECIST as well as per immune related Response Criteria (irRC) of NIS793 as single agent and in combination with PDR001 every 2 cycles from start of treatment until cycle 9 then every 3 cycles until end of treatment. During disease progression f/u, every 8 weeks for 40 weeks, then every 12 weeks.
- Duration of response (DOR) [ Time Frame: 48 months ]Evaluate the anti-tumor activity per RECIST as well as per immune related Response Criteria (irRC) of NIS793 as single agent and in combination with PDR001 every 2 cycles from start of treatment until cycle 9 then every 3 cycles until end of treatment (if applicable).
- Serum concentration-time profiles of NIS793 single agent and NIS793 in combination with PDR001 [ Time Frame: 48 months ]Evaluate serum concentration of NIS793 and PDR001 up to 8 cycles after start of treatment and at end of treatment.
- Presence of anti-NIS793 and anti-PDR001 antibodies [ Time Frame: 48 months ]Assess the emergence of anti-NIS793 and anti-PDR001 antibodies up to 8 cycles after start of treatment and at end of treatment.
- Concentration of anti-NIS793 and anti-PDR001 antibodies [ Time Frame: 48 months ]Assess the concentration of anti-NIS793 and anti-PDR001 antibodies up to 8 cycles after start of treatment and at end of treatment.
- Area under the curve (AUC) for NIS793 single agent and NIS793 in combination with PDR001. [ Time Frame: 48 months ]Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.
- Cmax for NIS793 single agent and NIS793 in combination with PDR001. [ Time Frame: 48 months ]Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.
- Tmax for NIS793 single agent and NIS793 in combination with PDR001. [ Time Frame: 48 months ]Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.
- Half life of NIS793 as single agent and in combination with PDR001. [ Time Frame: 48 months ]Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.
- Characterization of tumor infiltrating lymphocytes (TILs) by H&E [ Time Frame: 48 months ]Assess change from baseline of immune infiltrates in tumor biopsies after 2 cycles of treatment.
- Characterization of tumor infiltrating lymphocytes by immunohistochemistry using markers such as CD8 and PD-L1 [ Time Frame: 48 months ]Assess change from baseline in immunological markers in tumor biopsies after 2 cycles of treatment.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947165
United States, Tennessee | |
Sarah Cannon Research Institute SC | |
Nashville, Tennessee, United States, 37203 | |
United States, Utah | |
Huntsman Cancer Institute SC | |
Salt Lake City, Utah, United States, 84112 | |
Austria | |
Novartis Investigative Site | |
Salzburg, Austria, 5020 | |
Canada, Ontario | |
Novartis Investigative Site | |
Toronto, Ontario, Canada, M5G 2C1 | |
Germany | |
Novartis Investigative Site | |
Ulm, Germany, 89081 | |
Novartis Investigative Site | |
Wuerzburg, Germany, 97080 | |
Hong Kong | |
Novartis Investigative Site | |
Hong Kong, Hong Kong | |
Italy | |
Novartis Investigative Site | |
Milano, MI, Italy, 20132 | |
Novartis Investigative Site | |
Rozzano, MI, Italy, 20089 | |
Japan | |
Novartis Investigative Site | |
Kashiwa, Chiba, Japan, 277 8577 | |
Switzerland | |
Novartis Investigative Site | |
St. Gallen, Switzerland, 9007 | |
Taiwan | |
Novartis Investigative Site | |
Taipei, Taiwan, 10002 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02947165 |
Other Study ID Numbers: |
CNIS793X2101 2016-003044-36 ( EudraCT Number ) |
First Posted: | October 27, 2016 Key Record Dates |
Last Update Posted: | January 31, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Neoplasms Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Urologic Neoplasms Urogenital Neoplasms Kidney Diseases |
Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Diseases Spartalizumab Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |