CompletedPhase 1NCT02947165
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNIS793 and PDR001

The study team can explain what participation involves.

Who it may be forBreast Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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/

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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