Pembrolizumab for Solid Tumors
(INSPIRE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byLillian Siu, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers in patients with solid tumors during treatment with pembrolizumab and in relation to response to treatment. Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer cells.

Research Team

Lillian Siu, M.D.

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

Adults with advanced solid tumors that are incurable and have failed standard therapy or for whom no standard therapy exists. Participants must be willing to provide tumor tissue samples, use birth control, and have adequate organ function. Excluded are those with prior anti-PD-1/L1/L2 treatment, active infections including HIV/Hepatitis B/C, CNS metastases, certain malignancies or conditions that could affect trial participation.

Inclusion Criteria

Be willing and able to provide written informed consent/assent for the trial

I am 18 years old or older.

My cancer is advanced, cannot be cured, and has not responded to or is not suitable for standard treatments.

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Exclusion Criteria

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

I have a history of active tuberculosis.

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Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study is testing Pembrolizumab's effectiveness on various solid tumors by blocking a protein called PD-L1 to enhance the immune system's ability to destroy cancer cells. It aims to evaluate gene changes and immune biomarkers in relation to the treatment response.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Pembrolizumab will be given by intravenous infusion (IV, given by vein) at a dose of 200 mg, once every 3 weeks.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: