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)
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.
Detailed 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.
Arms & 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.
Outcome measures
Primary
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
Time frame: From screening (Days -28 to Day -1) up to 2 year 10 months
Confirmed Objective Response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Time frame: Up to 2 year 10 months
Secondary
Disease Control Rate (DCR)
Time frame: Up to 2 year 10 months
Duration of Response (DOR)
Time frame: Up to 2 year 10 months
Progression Free Survival (PFS)
Time frame: Up to 2 year 10 months
Overall Survival (OS)
Time frame: Up to 2 year 10 months
Serum Concentration of Volrustomig
Time frame: Up to 2 year 10 months
Trough concentration (Ctrough)
Time frame: Up to 2 year 10 months
Maximum Observed Concentration (Cmax)
Time frame: Up to 2 year 10 months
Area Under the Curve (AUC)
Time frame: Up to 2 year 10 months
Number of Participants with Positive Antidrug Antibodies (ADAs)
Time frame: Up to 2 year 10 months
Eligibility criteria
Study locations (7)
Research Site
Los Angeles, California, 90067
Research Site
Grand Junction, Colorado, 81501
Research Site
Wheat Ridge, Colorado, 80033
Research Site
Baltimore, Maryland, 21231
Research Site
Detroit, Michigan, 48202
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Tacoma, Washington, 98405