A Phase 3 Trial in Advanced Epithelioid Mesothelioma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVivace Therapeutics, Inc
About this trial
This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age 18 years or older at informed consent.
Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently.
Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1.
ECOG: 0-1.
Disqualifiers
Active brain metastases or primary CNS (central nervous system) tumors.
History of leptomeningeal metastases
Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known HIV positive or active Hepatitis B or Hepatitis C
Trial design
Design model
Parallel
Treatments tested in this trial
VT3989
Drug• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
gemcitabine
Drug• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
Vinorelbine
Drug• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Arm A - VT3989Experimental treatment 1 intervention
Group B: Arm B - Investigator's Choice ChemotherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Overall Survival (OS)
Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.
Time frame
Approximately 32-35 months after first randomizationSecondary outcomes
1
Progression-Free Survival by BICR
Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.
Time frame
From randomization through radiologic progression, death, up to approximately 3 years or more2
Treatment-Emergent Adverse Events and Serious Adverse Events
Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame
From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.3
Disease-related symptoms and health-related quality of life outcomes
Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.
Time frame
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more4
Overall Response Rate by BICR
Overall Response Rate by BICR Proportion with best overall response of complete response or partial response by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Time frame
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or moreOther outcomes
1
Pharmacokinetic Evaluation - Cmax
Peak plasma concentration of VT3989
Time frame
Up to Cycle 9 (each cycle is 28 days)2
Pharmacokinetic Evaluation - AUC
Area under the plasma concentration versus time curve (AUC)
Time frame
Up to Cycle 9 (each cycle is 28 days)3
Correlation between VT3989 exposure
Correlation between VT3989 exposure
Time frame
Up to Cycle 9 (each cycle is 28 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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