A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)
AstraZeneca
Summary
Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
Description
This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types. This platform study currently includes 2 substudies: Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \[NSQ\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B. Substudy 2: mNSCLC (squamous \[SQ\] or NSQ). Participants will enroll to the Arm 2A only. All arms will test a volrustomig dosing in combination with chemotherapy.
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration. * Life expectancy greater than or equal to (\>=) 12 weeks. * Adequate organ and bone marrow function. * Body weight greater than (\>) 35 kilograms (kg) at screening and at randomization. * Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2. * Absence of sensitizing epidermal growth factor receptor (EGFR) mutations. * Absence of documented tumor genomic alteration results from tests conducted as part of standard local practic…
Interventions
- DrugVolrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
- DrugCarboplatin
Participants will receive carboplatin via IV infusion.
- DrugPemetrexed
Participants will receive pemetrexed via IV infusion.
- DrugRamucirumab
Participants will receive ramucirumab via IV infusion.
- DrugPaclitaxel
Participants will receive paclitaxel via IV infusion.
Locations (77)
- Research SiteLos Angeles, California
- Research SiteGrand Junction, Colorado
- Research SiteWheat Ridge, Colorado
- Research SiteBaltimore, Maryland
- Research SiteDetroit, Michigan
- Research SiteChapel Hill, North Carolina