A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors
Summary
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.
Detailed description
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.
Arms & interventions
- BiologicalVolrustomig
IV Infusion
- DrugCisplatin
IV Infusion
- DrugCarboplatin
IV Infusion
- DrugPaclitaxel
IV Infusion
- Drug5-FU
IV Infusion
Outcome measures
Primary
Objective 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
Secondary
Duration Of Response (DOR)
Time frame: Through study completion, an average of 4 years
Progression free survival (PFS)
Time frame: Through study completion, an average of 4 years
Time to response (TTR)
Time frame: Through study completion, an average of 4 years
Overall Survival (OS)
Time frame: Through study completion, an average of 4 years
PK of volrustomig
Time frame: Through study completion, an average of 4 years
The immunogenicity of volrustomig
Time frame: Through study completion, an average of 4 years
Disease control rate (DCR)
Time frame: Through study completion, an average of 4 years
PFS landmark
Time frame: Through study completion, an average of 4 years
OS landmark
Time frame: Through study completion, an average of 4 years
Eligibility criteria
Study locations (6)
Research Site
Los Angeles, California, 90025
Research Site
Baltimore, Maryland, 21201
Research Site
New York, New York, 10065
Research Site
Stony Brook, New York, 11794
Research Site
Columbus, Ohio, 43210
Research Site
Philadelphia, Pennsylvania, 19104