Phase
Condition
Carcinoma
Esophageal Disorders
Squamous Cell Carcinoma
Treatment
QEQ278
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Adult men and women ≥ 18 years of age.
Histologically confirmed and documented advanced malignancies (locally advancedmalignancies, non-curable by surgery or radiotherapy and metastatic disease).Disease must be measurable, including presence of at least one measurable lesion, asdetermined by RECIST v1.1.
In the opinion of the treating investigator, patients must have received, but arenot benefitting from standard therapies, be intolerant or ineligible to receive suchtherapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard bylocal/institutional standard.
Non-small cell lung cancer
Esophageal squamous cell carcinoma
Renal cell carcinoma
HPV-associated head and neck squamous cell carcinoma
Must have a site of disease amenable to biopsy and be a candidate for tumor biopsyaccording to the treating institution's guidelines. The patient must be willing toundergo a new tumor biopsy at screening and during treatment.
Exclusion
Exclusion Criteria:
Active previously documented or suspected autoimmune disease. Patients withvitiligo, type I diabetes, residual hypothyroidism only requiring hormonereplacement, psoriasis not requiring systemic treatment, or conditions not expectedto recur should not be excluded. Patients previously exposed to anti-PD-1/PD-L1treatment who are adequately treated for skin rash or with replacement therapy forendocrinopathies should not be excluded.
Patients with a history of or current interstitial lung disease or pneumonitis ≥Grade 2.
Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-relatedtoxicity
Clinically significant cardiac disease or risk factors at screening
Insufficient bone marrow function at screening:
Infections:
Known history of testing positive for Human Immunodeficiency Virus infection.
Active Hepatitis B and / or Hepatitis C.
Active, documented COVID-19 infection
Known history of tuberculosis
Any serious uncontrolled infection (acute or chronic).
Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or anyimmunosuppressive therapy, other than replacement-dose steroids in the setting ofadrenal insufficiency, within 7 days of the first dose of study treatment. Topical,inhaled, and ophthalmic steroids are allowed.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Bruxelles, 1200
BelgiumSite Not Available
Novartis Investigative Site
Paris, 75231
FranceSite Not Available
Novartis Investigative Site
Essen, 45147
GermanySite Not Available
Novartis Investigative Site
Milano, MI 20133
ItalySite Not Available
Novartis Investigative Site
Kashiwa, Chiba 277 8577
JapanSite Not Available
Novartis Investigative Site
Singapore, 168583
SingaporeSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainSite Not Available
Novartis Investigative Site
Taipei, 10002
TaiwanSite Not Available
UCLA Medical Center Santa Monica Location
Los Angeles, California 90095
United StatesActive - Recruiting
University Of California Los Angeles Santa Monica Location
Los Angeles, California 90095
United StatesActive - Recruiting
University of California LA
Los Angeles, California 90095
United StatesSite Not Available
University of California LA Santa Monica Location
Los Angeles, California 90095
United StatesSite Not Available
Florida Cancer Specialists
Fort Myers, Florida 33901
United StatesSite Not Available
Florida Cancer Specialists Sarasota Office
Fort Myers, Florida 33901
United StatesSite Not Available
Massachusetts General Hospital Dept. of Mass General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
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