A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adult Participants With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas - (THE INVINCIBLE-3 TRIAL)

Conditions

liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic), Undifferentiated pleomorphic sarcoma, Leiomyosarcoma (non-uterine)

Brief summary

Overall survival (OS), as defined as the time from date of randomization to date of death due to any cause.

Detailed description

OS as defined as the time from date of randomization to date of death due to any cause., Exploratory: The incidence of grade 3 or higher drug-related AEs will be assessed by the incidence of > grade 3 drug-related AEs according to the CTCAE (v6.0)., Exploratory: Change from baseline in the global health status/QoL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months)., Exploratory: Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment., Exploratory: Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 (Time Frame: Up to 24 months)., Exploratory: Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30., Exploratory: Changes in safety parameters including laboratory test results, ECOG performance status, etc.

Related papers

No related papers found yet.

Interventions

DRUGHALAVEN 0.44 mg/ml solution for injection

DRUGTrabectedin EVER Pharma 1 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

DRUGPazopanib PharOS 200 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS), as defined as the time from date of randomization to date of death due to any cause.	—

Secondary

Measure	Time frame
OS as defined as the time from date of randomization to date of death due to any cause., Exploratory: The incidence of grade 3 or higher drug-related AEs will be assessed by the incidence of > grade 3 drug-related AEs according to the CTCAE (v6.0)., Exploratory: Change from baseline in the global health status/QoL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months)., Exploratory: Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment., Exploratory: Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 (Time Frame: Up to 24 months)., Exploratory: Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL sc	—

Measure

Time frame

OS as defined as the time from date of randomization to date of death due to any cause., Exploratory: The incidence of grade 3 or higher drug-related AEs will be assessed by the incidence of > grade 3 drug-related AEs according to the CTCAE (v6.0)., Exploratory: Change from baseline in the global health status/QoL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months)., Exploratory: Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment., Exploratory: Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 (Time Frame: Up to 24 months)., Exploratory: Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL sc

—

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed