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Monoclonal Antibodies
Pembrolizumab for Solid Tumors (INSPIRE Trial)
Phase 2
Waitlist Available
Led By Lillian Siu, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years of age or older on day of signing informed consent
Have histologically or cytologically-documented, locally-advanced, or metastatic solid malignancy that is incurable and has either failed prior standard therapy, for which no standard therapy exists, or standard therapy is not considered appropriate by the patient and treating physician. There is no limit to the number of prior treatment regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
INSPIRE Trial Summary
This trial will study the changes in genes and immune cells of patients with solid tumors before and during treatment with pembrolizumab to see if there is a correlation with how well the patients respond to the treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Pembrolizumab may cause side effects such as immune-related inflammation of organs (like lungs or intestines), fatigue, infusion reactions (symptoms related to the administration of the drug), skin rash, hormonal gland problems (like thyroid dysfunction), and increased risk of infection.
INSPIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is advanced, cannot be cured, and has not responded to or is not suitable for standard treatments.
Select...
I am willing and able to provide a new tissue sample from my tumor for the study.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am not pregnant.
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My cancer is advanced and cannot be removed by surgery.
INSPIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in genomic and immune biomarkers that will be measured in blood and tumor pre-treatment, on-treatment and at progression (progression biopsies only done for those who have complete or partial responses, or stable disease for more than 4 months)
Secondary outcome measures
Baseline tumor RNA expression profile for immune inhibitory genes
Changes in circulating tumor DNA genomic biomarkers
Changes in immune cell subsets in the blood and tumor microenvironment
+6 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
INSPIRE Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,471 Previous Clinical Trials
484,870 Total Patients Enrolled
15 Trials studying Ovarian Cancer
3,483 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,874 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
Lillian Siu, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I am currently being treated for an infection.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have been diagnosed with HIV.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.I am willing and able to provide a new tissue sample from my tumor for the study.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well.I am not pregnant.I have an autoimmune disease treated with medication in the last 2 years.You have a measurable disease according to specific medical guidelines.I have another cancer that is getting worse or needs treatment.I haven't had cancer treatment in the last 2 weeks or still have side effects.I have cancer that has spread to my brain or spinal cord.You currently have active Hepatitis B or Hepatitis C.You are allergic to pembrolizumab or any of the ingredients in it.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I have not received a live vaccine in the last 30 days.My cancer is advanced and cannot be removed by surgery.I have or had lung inflammation not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are involved in this research?
"This particular trial is no longer looking for patients. The posting dates were from March 21st, 2016 to April 21st, 2022. However, there are 2909 other trials concerning melanoma and 1000 Pembrolizumab studies that are still admitting patients."
Answered by AI
For what purpose is Pembrolizumab most often employed?
"Pembrolizumab is often used to treat patients with malignant neoplasms. Additionally, this medication can be useful for those suffering from unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease progression."
Answered by AI
When was Pembrolizumab cleared by the FDA?
"Pembrolizumab has been evaluated in a Phase 2 clinical trial, so there is some data suggesting that it is safe for use. However, there is no efficacy data available yet."
Answered by AI
Are people still being recruited to participate in this research project?
"Unfortunately, this particular clinical trial is not currently looking for participants. This is according to the most recent update on clinicaltrials.gov, which was edited on April 21st, 2022. It's worth noting that there are 3909 other trials actively recruiting patients right now."
Answered by AI
Are there other ongoing research projects that are testing Pembrolizumab?
"Pembrolizumab is being trialed in 1000 ongoing studies, with the 122 most critical ones being Phase 3 trials. The majority of these are based in Houston, TX, but there are 36030 other locations testing Pembrolizumab's efficacy."
Answered by AI
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