Table of Contents

• Clinical trial overview
• Cancer types being studied
• How the studies are designed
• Who can take part
• What the trials measure
• Key trial snapshot

Clinical trial overview

These studies are investigating Livmoniplimab in people with advanced cancer, often in combination with Budigalimab and sometimes with chemotherapy or other cancer drugs.^{[1][2][3][4][5]}

All of the trials listed are interventional studies, which means researchers give the study treatment and then measure the results.^{[1][2][3][4][5]}

The main goals are to find the best dose, check safety, and see how well the treatment works in different cancer groups.^{[1][2][3][4][5]}

Cancer types being studied

One trial is in locally advanced or metastatic hepatocellular carcinoma, which is a liver cancer that has grown locally or spread to other parts of the body.^[1]

Another trial is in metastatic urothelial carcinoma, a cancer of the urinary tract that has spread.^[2]

A separate study looks at locally advanced or metastatic solid tumors, which means many different tumor types that are advanced or have spread.^[3]

One study is in untreated metastatic non-squamous non-small cell lung cancer, meaning lung cancer that has spread and has not yet been treated systemically in this study setting.^[4]

Another hepatocellular carcinoma study includes people with Child-Pugh A disease, which describes better liver function, and people who have already progressed after an immune checkpoint inhibitor-containing regimen.^[5]

How the studies are designed

The studies include Phase 1, Phase 2, and Phase 4 trials.^{[1][2][3][4][5]}

The Phase 1 study in solid tumors uses a dose escalation part, where the dose is slowly adjusted to find the recommended Phase 2 dose, and a dose expansion part, where the treatment is tested in selected tumor types.^[3]

Some studies use a two-stage plan, where Stage 1 helps choose the best dose and Stage 2 checks the treatment effect in a larger group.^[1][4]

In the non-small cell lung cancer study, Stage 1 is Phase 2 and Stage 2 is Phase 3.^[4]

In the hepatocellular carcinoma and non-small cell lung cancer Phase 4 studies, the trials compare Livmoniplimab and Budigalimab combinations with other treatment options, including chemotherapy or pembrolizumab-based treatment.^[1][4]

Who can take part

The main participants are adult patients with advanced or metastatic cancer.^[1][2][4]

Some trials are for people who have not previously received systemic treatment, meaning they have not yet had treatment that works throughout the body for that cancer.^[1][4]

Other trials are for people whose disease has progressed after previous checkpoint inhibitor treatment or after an immune checkpoint inhibitor-containing regimen.^[2][5]

The solid tumor study includes people with locally advanced or metastatic solid tumors, so the group is broader than one specific cancer type.^[3]

What the trials measure

One key endpoint is best overall response or BOR, which looks at whether the cancer has a complete response or partial response.^[1][4][5]

Complete response means no visible sign of cancer on study scans or exams, while partial response means the cancer has shrunk but not disappeared.^[1][4][5]

Another major endpoint is overall survival (OS), which measures the time from randomization until death from any cause.^[2][4]

The solid tumor study also measures objective response rate (ORR), which is the share of patients whose tumors shrink enough to count as a response.^[3]

The non-small cell lung cancer study also looks at adverse events, which are unwanted medical problems during the study, and disease activity, which shows how active or controlled the cancer is during treatment.^[4]

Key trial snapshot

The table below gives a short view of the main studies, including trial ID, phase, condition, status, and enrollment.^{[1][2][3][4][5]}