Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
NCT Number: NCT06535607
Acronym: eVOLVE-02
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cervical Cancer|Head and Neck Squamous Cell Carcinoma
Interventions: BIOLOGICAL: Volrustomig
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2026-08-31
Locations: Research Site, Beijing, CN-100730, China|Research Site, Changchun, 130021, China|Research Site, Changsha, 410008, China|Research Site, Chongqing, 400030, China|Research Site, Fuzhou, 350011, China|Research Site, Jining, 272029, China|Research Site, Kunming, 650118, China|Research Site, Nanchang, 330006, China|Research Site, Shandong, China|Research Site, Shanghai, 200120, China|Research Site, Shenyang, 110004, China|Research Site, Wuhan, 430022, China|Research Site, Wuhan, 430079, China

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.

Primary Outcome Measures: 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., Through study completion, an average of 2.5 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., Through study completion, an average of 2.5 years
Secondary Outcome Measures: 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., Through study completion, an average of 2.5 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., Through study completion, an average of 2.5 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., Through study completion, an average of 2.5 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., Through study completion, an average of 2.5 years|PK of volrustomig, Concentration of Volrustomig in serum., Through study completion, an average of 1.5 years|The immunogenicity of volrustomig, Incidence of ADAs against volrustomig in serum., Through study completion, an average of 2.5 years|Objective response rate (ORR) in participants with a positive expression level of PD-L1 and a high expression level of PD-L1, 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 (For cervical cancer sub-study 1), Through study completion, an average of 2.5 years|Objective response rate (ORR) in participants with different expression levels of PD-L1, 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 (For HNSCC sub-study 2), Through study completion, an average of 2.5 years