Phase
Condition
Non-small Cell Lung Cancer
Mesothelioma
Treatment
VT3989
Nivolumab & Ipilimumab
Osimertinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic orunresectable malignant mesothelioma (including both pleural and non-pleural) whohave not received systemic therapy.
Part 3 Combination Cohort B: Patients with pathologically diagnosed incurablelocally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19deletions or exon 21 L858R mutations, with or without prior treatment withOsimertinib.
Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solidtumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may beused for pleural extension of non-pleural mesothelioma or for mixed pleural andperitoneal (or other) mesothelioma.
ECOG: 0-1.
Adequate organ functions, including the liver, kidneys, and hematopoietic system.
Exclusion
Exclusion Criteria:
Active brain metastases or primary CNS (central nervous system) tumors.
History of leptomeningeal metastases
Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiringsystemic therapy
Known HIV positive or active Hepatitis B or Hepatitis C
Clinically significant cardiovascular disease
Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula);except for Part 2 Expansion Cohort 3, the QTcF interval criteria is > 450 msec).
Additional active malignancy that may confound the assessment of the study endpoints
Women who are pregnant or breastfeeding
Prior treatment with TEAD inhibitor, except for EHE patients.
Study Design
Study Description
Connect with a study center
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Peter MacCullum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234 3168
AustraliaActive - Recruiting
Peter MacCullum Cancer Centre
Melbourne 2158177, Victoria 2145234 3000
AustraliaActive - Recruiting
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
Linear Clinical Research
Nedlands 2064874, Western Australia 2058645 6009
AustraliaActive - Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United StatesSite Not Available
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco 5391959, California 5332921 94158
United StatesActive - Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
M Health Fairview University of Minnesota Medical Center
Minneapolis 5037649, Minnesota 5037779 55455
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center-
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
NEXT Oncology
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Arlington, Virginia 22201
United StatesSite Not Available
Virginia Cancer Specialists, PC
Arlington 4744709, Virginia 6254928 22201
United StatesActive - Recruiting

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