A Study of GSK4381562 Alone or in Combination with Dostarlimab or GSK4428859A for Patients with Advanced Kidney Cancer

Trial ID: NCT05277051
Kidney Cancer Type: Clear cell only


GSK4381562,  Dostarlimab, and  GSK4428859A belong to a class of drugs called immune checkpoint inhibitors. These drugs work by helping to activate the body’s own immune defences in order to target and destroy cancer cells.

Dostarlimab targets the immune checkpoint molecule PD-1. This is similar to Nivolumab (Opdivo®), which is a Health Canada-approved immunotherapy for kidney cancer.

GSK4381562 targets a newly identified immune checkpoint molecule called PVRIG. There is evidence that therapies targeting PVRIG may help recruit a special kind of immune cell called Natural Killer cells to enhance anti-tumour immune activity.

GSK4428859A targets another newly identified immune checkpoint molecule called TIGIT. Like PVRIG, there is evidence that targeting TIGIT may help activate Natural Killer cells.

Since these drugs are still in the clinical trial phase, they have the placeholder names GSK4381562 and GSK4428859A rather than commercial trade names.

The Trial:

This is a phase 1 study that will investigate the safety and effectiveness of GSK4381562 either alone, in combination with Dostarlimab or in combination with Dostarlimab + GSK4428859A in patients with several different cancer types, including kidney cancer.

The treatment you receive will be assigned at random by the doctor overseeing your care.

Group 1: GSK4381562 alone
Group 2: GSK4381562 + Dostarlimab
Group 3: GSK4381562 + Dostarlimab + GSK4428859A

There is no control group in the study, so there will be no “placebo”, and all eligible patients will receive treatment.

Basic Eligibility:

  • Clear Cell Kidney Cancer Only
  • Advanced kidney cancer that cannot be removed by surgery

Additional eligibility criteria will apply. Please speak to your doctor.


Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentrePrincess Margaret Cancer Centre Principal InvestigatorNot Given LocationToronto, ON Trial StatusRecruiting
Hospital / Cancer CentreThe Ottawa Hospital Principal InvestigatorNot Given LocationOttawa, ON Trial StatusRecruiting
Kidney Cancer Canada