Phase
Condition
Melanoma
Treatment
TNO155 in combination with EGF816 (nazartinib)
TNO155
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to understand and voluntarily sign the ICF and able to comply with the studyvisit schedule and the other protocol requirements.
Patient (male or female) ≥18 years of age willing to agree to not father achild/become pregnant and comply with effective contraception criteria.
Must have progressed following standard therapy, or for whom, in the opinion of theInvestigator, no effective standard therapy exists, is tolerated or is appropriate.
ECOG (Eastern cooperative oncology group) performance status ≤2 Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
Patients must be screened for Hepatitis B virus and Hepatitis C virus
Exclusion
Exclusion Criteria:
Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's)
History or current evidence of retinal vein occlusion (RVO) or current risk factorsfor RVO.
Any medical condition that would, in the investigator's judgment, prevent thepatient's participation in the clinical study due to safety concerns or compliancewith clinical study procedures.
Clinically significant cardiac disease.
Active diarrhea or inflammatory bowel disease
Insufficient bone marrow function
Insufficient hepatic and renal function. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
Patients receiving concomitant immunosuppressive agents or chronic corticosteroidsuse at the time of study entry.
Patients who have undergone a bone marrow or solid organ transplant
Patients with a history or presence of interstitial lung disease or interstitialpneumonitis
Bullous and exfoliative skin disorders at screening of any grade
Presence of clinically significant ophthalmological abnormalities that mightincrease the risk of corneal epithelial injury
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Novartis Investigative Site
Milano, MI 20141
ItalySite Not Available
Novartis Investigational Site
Kobe,
JapanSite Not Available
Novartis Investigative Site
Kobe shi, 650-0017
JapanSite Not Available
Novartis Investigative Site
Kobe-shi, 650-0017
JapanSite Not Available
Novartis Investigative Site
Seoul, 03080
Korea, Republic ofSite Not Available
Novartis Investigative Site
Rotterdam, Zuid Holland 3015 GD
NetherlandsSite Not Available
Novartis Investigative Site
Amsterdam, 1066 CX
NetherlandsSite Not Available
Novartis Investigative Site
Leiden, 2300 RC
NetherlandsSite Not Available
Novartis Investigative Site
Singapore, 168583
SingaporeSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainSite Not Available
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya 08907
SpainSite Not Available
Novartis Investigative Site
Madrid, 28040
SpainSite Not Available
Novartis Investigative Site
Taipei, 10002
TaiwanSite Not Available
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United StatesSite Not Available
H Lee Moffitt Cancer Center and Research Institute .
Tampa, Florida 33612
United StatesSite Not Available
Dana Farber Cancer Center
Boston, Massachusetts 02215
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02215
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloane Ketterin Cancer Ctr
New York, New York 10065
United StatesSite Not Available
Memorial Sloane Ketterin Cancer Ctr Main Centre
New York, New York 10065
United StatesSite Not Available
Memorial Sloane Kettering Cancer Center Main Centre
New York, New York 10065
United StatesActive - Recruiting
NYU Langone Health .
New York, New York 10016
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37221
United StatesSite Not Available
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