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
AstraZeneca
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 at the time of signing the ICF. * Provision of tumor sample to assess the PD-L1 expression (if applicable). * ECOG performance status of 0 or 1. * Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable). * Life expectancy ≥ 12 weeks. * Adequate organ and bone marrow function. * Body weight \> 35 kg * Capable of giving signed informed consent. Exclusion Criteria: * Spinal cord compression. * For sub-study 1,2,3,4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study i…
Interventions
- BiologicalVolrustomig
IV Infusion
- DrugCisplatin
IV Infusion
- DrugCarboplatin
IV Infusion
- DrugPaclitaxel
IV Infusion
- Drug5-FU
IV Infusion
Locations (59)
- Research SiteLos Angeles, California
- Research SiteBaltimore, Maryland
- Research SiteStony Brook, New York
- Research SiteColumbus, Ohio
- Research SiteIjuí
- Research SiteLondrina