Phase
Condition
Mesothelioma
Non-small Cell Lung Cancer
Treatment
Nivolumab & Ipilimumab
Osimertinib
VT3989
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1: pathologically diagnosed metastatic solid tumor or mesothelioma that hasprogressed on or after all approved therapies of known clinical benefit except ifthe patient refuses or is not a candidate for such therapy;
Part 2 Expansion Cohorts 1 and 2: in mesothelioma cohorts, pathologically diagnosedadvanced malignant mesothelioma with or without NF2 mutations, that has progressedon or after all approved therapies of known clinical benefit except if the patientrefuses or is not a candidate for such therapy.
Part 2 Expansion Cohort 3: non-pleural mesothelioma patients with epithelioidhistology, relapsed from or refractory to prior platinum-based chemotherapy andimmunotherapy.
Part 2 Expansion Cohort 4: in the solid tumor cohort, pathologically diagnosedmetastatic or locally advanced solid tumor with clearly inactivating NF2mutations/alterations or YAP/TAZ gene rearrangements, which have progressed on orafter approved therapies of known clinical benefit except if the patient refuses oris not a candidate for such therapy.
Part 2 Expansion Cohort 5: pathologically diagnosed advanced malignant pleuralmesothelioma with epithelioid histology, that has progressed on or after licensedimmunotherapy, chemotherapy or combined chemoimmunotherapy except if the patientrefuses or is not a candidate for such therapy.
Part 3 Combination Cohort A: pathologically diagnosed, metastatic or unresectablemalignant mesothelioma including both pleural and non-pleural) patients who have notreceived systemic therapy.
Part 3 Combination Cohort B: pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21L858R mutations, with or without prior treatment with Osimertinib.
Part 1: evaluable or measurable disease per RECIST v1.1 or mRECIST
Part 2 and 3: measurable disease per RECIST v1.1 for non-pleural mesothelioma orother solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma.mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixedpleural and peritoneal (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
AustraliaActive - Recruiting
Peter MacCullum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center-
New York, New York 10065
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
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