eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.
eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors. In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer. In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma. In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma. In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma. In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
257
IV Infusion
IV Infusion
IV Infusion
IV Infusion
IV Infusion
Research Site
Los Angeles, California, United States
WITHDRAWNResearch Site
Baltimore, Maryland, United States
NOT_YET_RECRUITINGResearch Site
New York, New York, United States
NOT_YET_RECRUITINGResearch Site
Stony Brook, New York, United States
NOT_YET_RECRUITINGObjective response rate (ORR)
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1.
Time frame: Through study completion, an average of 4 years
The number of participants with adverse events/serious adverse events
Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
Time frame: Through study completion, an average of 4 years
Duration Of Response (DOR)
DoR is defined as the time from the date of first documented confirmed response (which is subsequently confirmed) until date of documented progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause.
Time frame: Through study completion, an average of 4 years
Progression free survival (PFS)
PFS is defined as the time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause.
Time frame: Through study completion, an average of 4 years
Time to response (TTR)
TTR is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1, as assessed by Investigator or ICR.
Time frame: Through study completion, an average of 4 years
Overall Survival (OS)
OS is defined as the time from the date of first dose of study intervention until the date of death due to any cause.
Time frame: Through study completion, an average of 4 years
PK of volrustomig
Concentration of Volrustomig in serum.
Time frame: Through study completion, an average of 4 years
The immunogenicity of volrustomig
Incidence of ADAs against volrustomig in serum.
Time frame: Through study completion, an average of 4 years
Disease control rate (DCR)
Disease control rate is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or SD, as determined by Investigator per RECIST 1.1.
Time frame: Through study completion, an average of 4 years
PFS landmark
The landmark of PFS rates at 6, 9, and 12 months.
Time frame: Through study completion, an average of 4 years
OS landmark
The median OS and the landmark of OS rate at 12 months.
Time frame: Through study completion, an average of 4 years
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Research Site
Columbus, Ohio, United States
NOT_YET_RECRUITINGResearch Site
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGResearch Site
Clayton, Australia
RECRUITINGResearch Site
Nedlands, Australia
NOT_YET_RECRUITINGResearch Site
Ijuí, Brazil
RECRUITINGResearch Site
Londrina, Brazil
RECRUITING...and 85 more locations