NCT06535607

Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 257 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sub-study 1 Cervical Cancer (Volrustomig Monotherapy)
• Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy)
• Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)
• Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)
• Sub-study 5 Unresectable Pleural Mesothelioma (Volrustomig Monotherapy)

Interventions

Type	Name	Description
BIOLOGICAL	Volrustomig	IV Infusion
DRUG	Cisplatin	IV Infusion
DRUG	Carboplatin	IV Infusion
DRUG	Paclitaxel	IV Infusion
DRUG	5-FU	IV Infusion

Timeline

• Start date: 2024-08-22
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2024-08-02
• Last updated: 2026-03-24

Locations

59 sites across 6 countries: United States, Brazil, China, South Korea, Taiwan, Vietnam

Regulatory

• FDA-regulated drug study