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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
Must not have
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Has a known history of active TB (Bacillus Tuberculosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am willing and able to provide a new tissue sample from my tumor for the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am not pregnant.
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My cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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I have a history of active tuberculosis.
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I am currently being treated for an infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have been diagnosed with HIV.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have another cancer that is getting worse or needs treatment.
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I haven't had cancer treatment in the last 2 weeks or still have side effects.
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I have cancer that has spread to my brain or spinal cord.
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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.
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I have or had lung inflammation not caused by an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
503,072 Total Patients Enrolled
15 Trials studying Ovarian Cancer
3,033 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,000 Previous Clinical Trials
5,181,732 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,424 Patients Enrolled for Ovarian Cancer
Lillian Siu, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02644369 — Phase 2
Ovarian Cancer Research Study Groups: Pembrolizumab
Ovarian Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02644369 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02644369 — Phase 2
~0 spots leftby Dec 2024
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