CompletedPhase 1NCT02947165

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.

Checked against the public recordLast updated Jan 31, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations12
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: NIS793; Drug: PDR001
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Sarah Cannon Research Institute SCNashville, Tennessee
  • Huntsman Cancer Institute SCSalt Lake City, Utah
  • Novartis Investigative SiteSalzburg
  • Novartis Investigative SiteToronto, Ontario
  • Novartis Investigative SiteUlm
  • Novartis Investigative SiteWürzburg
  • Novartis Investigative SiteHong Kong
  • Novartis Investigative SiteMilan, MI
  • Novartis Investigative SiteRozzano, MI
  • Novartis Investigative SiteKashiwa, Chiba
  • Novartis Investigative SiteSankt Gallen
  • Novartis Investigative SiteTaipei

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 31, 2022. Always confirm current availability with the study team.

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