Trials / Recruiting
RecruitingNCT06448754
Volrustomig Priming Regimens Exploratory Phase II Platform Study
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Volrustomig | Participants will receive volrustomig via intravenous (IV) infusion. |
| DRUG | Carboplatin | Participants will receive carboplatin via IV infusion. |
| DRUG | Pemetrexed | Participants will receive pemetrexed via IV infusion. |
| DRUG | Ramucirumab | Participants will receive ramucirumab via IV infusion. |
| DRUG | Paclitaxel | Participants will receive paclitaxel via IV infusion. |
Timeline
- Start date
- 2024-08-27
- Primary completion
- 2027-07-30
- Completion
- 2027-07-30
- First posted
- 2024-06-07
- Last updated
- 2026-04-13
Locations
77 sites across 15 countries: United States, Canada, China, France, Georgia, Greece, Italy, Malaysia, Portugal, Romania, Serbia, South Korea, Spain, Switzerland, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06448754. Inclusion in this directory is not an endorsement.