Table of Contents
- Clinical trials overview
- Who can join these studies
- Cancer types being studied
- Trial phases and study designs
- Main endpoints and what they mean
- Key trials of Volrustomig
Clinical trials overview
Volrustomig is being tested in interventional trials, which means researchers give a study treatment and measure the results.[1] The trials in the source data focus on cancer, especially advanced, metastatic, or locally advanced disease.[1]
Many studies look at Volrustomig alone or with other anticancer drugs, and some compare it with placebo, observation, or standard treatment.[1][2] The main goals are to check safety, tolerability, and how well the treatment works against tumors.[1][2]
Who can join these studies
Most trials include adults with advanced or metastatic cancer.[1] Some studies are more specific and include women and young adults with locally advanced cervical cancer, people with unresected head and neck cancer after chemoradiotherapy, or patients whose tumors have certain features such as PD-L1 expression or mature tertiary lymphoid structures.[1][2]
Some trials also focus on people with cancer that has not been removed by surgery, or on patients whose cancer has spread or cannot be removed completely.[1][2]
Cancer types being studied
The source data show Volrustomig trials in several cancer types, including head and neck cancer, cervical cancer, non-small cell lung cancer, pleural mesothelioma, colorectal cancer, gastric cancer, gastroesophageal junction adenocarcinoma, hepatobiliary cancer, renal cell carcinoma, and esophageal squamous cell carcinoma.[1][2]
Several studies are designed for broad groups of solid tumors, which means cancers that form a mass in an organ or tissue rather than a blood cancer.[1][2] Some studies also separate patients by tumor features, such as PD-L1 status, MSI, dMMR, or mature tertiary lymphoid structures.[1][2]
Trial phases and study designs
The studies include Phase 1, Phase 2, and Phase 3 trials.[1] Phase 1 studies mainly focus on safety, side effects, and dose-finding, while Phase 2 and Phase 3 studies look more closely at whether Volrustomig helps control cancer and how it compares with other approaches.[1][2]
Some trials are master protocols, which are larger study plans that can include several sub-studies under one main trial.[1][2] This design lets researchers test different cancer groups or drug combinations in a more organized way.[1][2]
Main endpoints and what they mean
One common endpoint is progression-free survival (PFS), which is the time before the cancer gets worse or the person dies from any cause.[1] Trials in cervical cancer, head and neck cancer, colorectal cancer, and metastatic non-small cell lung cancer use PFS as a major outcome.[1]
Another key endpoint is overall survival (OS), which measures how long people live after randomization in the study.[1] The pleural mesothelioma trial uses OS as its primary outcome, and the metastatic non-small cell lung cancer trial also measures OS in the PD-L1 less-than-1% group.[1]
Researchers also measure objective response rate (ORR), which means the share of patients whose tumors shrink in a confirmed way.[1] Other safety measures include adverse events, serious adverse events, dose-limiting toxicities, lab tests, heart tests, vital signs, and other checks of tolerability.[1][2]
Key trials of Volrustomig
Head and neck cancer: One Phase 3 study is testing Volrustomig after chemoradiotherapy in adults with unresected locally advanced head and neck squamous cell cancer that expresses PD-L1.[1] The goal is to show better progression-free survival than observation alone.[1]
Cervical cancer: A Phase 3 trial in women and young adults with locally advanced cervical cancer is comparing Volrustomig with placebo.[2] The main outcome is progression-free survival, measured for up to about 7 years.[2]
Pleural mesothelioma: A Phase 3 study in unresectable pleural mesothelioma is testing Volrustomig with carboplatin plus pemetrexed against the investigator’s choice of standard care.[3] The main outcome is overall survival.[3]
Metastatic non-small cell lung cancer: One Phase 3 trial is comparing Volrustomig plus chemotherapy with pembrolizumab plus chemotherapy in patients with PD-L1 less than 1%.[4] The study measures progression-free survival and overall survival in this group.[4]
Colorectal cancer: A Phase 2 master protocol includes a sub-study testing Volrustomig with FOLFIRI plus bevacizumab versus FOLFIRI plus bevacizumab alone in colorectal cancer without liver metastases.[5] The key outcome is progression-free survival, along with safety.[5]
Other solid tumors: Additional Phase 2 studies are exploring Volrustomig in metastatic solid tumors with mature tertiary lymphoid structures, advanced hepatobiliary cancer, gastric and gastroesophageal junction adenocarcinoma, renal cell carcinoma, esophageal squamous cell carcinoma, and other specified solid tumors.[6][7][8][9][10][11]
Safety-focused early study: A Phase 1b study in advanced renal cell carcinoma is looking at safety, tolerability, dose limits, and objective response rate for Volrustomig with other treatment options.[11] A small Phase 2 study in MSI and/or dMMR metastatic cancer also measured safety first and then objective response rate at 24 weeks.[12]
