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Clinical Trial Record

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

2017-04-25

2021-06-18

2021-06-18

120

Study Overview

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

N/A

  • Breast Cancer
  • Lung Cancer
  • Hepatocellular Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Renal Cancer
  • DRUG: NIS793
  • DRUG: PDR001
  • CNIS793X2101
  • 2016-003044-36 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2016-10-18  

N/A  

2022-01-28  

2016-10-25  

N/A  

2022-01-31  

2016-10-27  

N/A  

2022-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: NIS793

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.
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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of DLTs, AEs, SAEs and dose reductions / interruptions for NIS793Up to 90 days after end of treatment
Incidence of DLTs, AEs, SAEs and dose reductions/interruptions for NIS793 in combination with PDR001Up to 150 days after end of treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Best overall response (BOR)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).48 months
Disease control rate (DCR)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).48 months
Overall response rate (ORR)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).48 months
Progression free survival (PFS)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.48 months
Duration of response (DOR)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).48 months
Serum concentration-time profiles of NIS793 single agent and NIS793 in combination with PDR001Evaluate serum concentration of NIS793 and PDR001 up to 8 cycles after start of treatment and at end of treatment.48 months
Presence of anti-NIS793 and anti-PDR001 antibodiesAssess the emergence of anti-NIS793 and anti-PDR001 antibodies up to 8 cycles after start of treatment and at end of treatment.48 months
Concentration of anti-NIS793 and anti-PDR001 antibodiesAssess the concentration of anti-NIS793 and anti-PDR001 antibodies up to 8 cycles after start of treatment and at end of treatment.48 months
Area under the curve (AUC) for NIS793 single agent and NIS793 in combination with PDR001.Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.48 months
Cmax for NIS793 single agent and NIS793 in combination with PDR001.Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.48 months
Tmax for NIS793 single agent and NIS793 in combination with PDR001.Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.48 months
Half life of NIS793 as single agent and in combination with PDR001.Characterize the pharmacokinetic properties of NIS793 given alone and in combination with PDR001.48 months
Characterization of tumor infiltrating lymphocytes (TILs) by H&EAssess change from baseline of immune infiltrates in tumor biopsies after 2 cycles of treatment.48 months
Characterization of tumor infiltrating lymphocytes by immunohistochemistry using markers such as CD8 and PD-L1Assess change from baseline in immunological markers in tumor biopsies after 2 cycles of treatment.48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Bauer TM, Santoro A, Lin CC, Garrido-Laguna I, Joerger M, Greil R, Spreafico A, Yau T, Goebeler ME, Hutter-Kronke ML, Perotti A, Juif PE, Lu D, Barys L, Cremasco V, Pelletier M, Evans H, Fabre C, Doi T. Phase I/Ib, open-label, multicenter, dose-escalation study of the anti-TGF-beta monoclonal antibody, NIS793, in combination with spartalizumab in adult patients with advanced tumors. J Immunother Cancer. 2023 Nov 29;11(11):e007353. doi: 10.1136/jitc-2023-007353.
    • Dodagatta-Marri E, Meyer DS, Reeves MQ, Paniagua R, To MD, Binnewies M, Broz ML, Mori H, Wu D, Adoumie M, Del Rosario R, Li O, Buchmann T, Liang B, Malato J, Arce Vargus F, Sheppard D, Hann BC, Mirza A, Quezada SA, Rosenblum MD, Krummel MF, Balmain A, Akhurst RJ. alpha-PD-1 therapy elevates Treg/Th balance and increases tumor cell pSmad3 that are both targeted by alpha-TGFbeta antibody to promote durable rejection and immunity in squamous cell carcinomas. J Immunother Cancer. 2019 Mar 4;7(1):62. doi: 10.1186/s40425-018-0493-9.
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