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PD-1 Inhibitor
Immunotherapy for Cancer
Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically-documented, advanced solid tumor of specified types
Progression of tumor or intolerance to therapies known to provide clinical benefit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10.5 years
Awards & highlights
Study Summary
This trial is testing a new immunotherapy drug for people with advanced cancer who have progressed on standard of care therapy.
Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after standard treatments. They must have a specific type of tumor, be able to provide tissue samples, and have measurable disease. Participants should be relatively active (ECOG 0 or 1), expected to live at least 3 months, and have good organ function. Women who can bear children must use contraception.Check my eligibility
What is being tested?
The study tests pembrolizumab in patients with various unresectable or metastatic solid tumors that haven't responded well to existing therapies. The goal is to see how effective this drug is on different types of cancer by monitoring the participants' responses.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues, and could potentially worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed by lab tests and is an advanced solid tumor.
Select...
My cancer has worsened or I can't tolerate my current treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 10.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Percentage of Participants who Discontinue Study Intervention due to AEs
+2 moreSide effects data
From 2022 Phase 3 trial • 1274 Patients • NCT0222089412%
Weight decreased
9%
Aspartate aminotransferase increased
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Diarrhoea
9%
Hypothyroidism
9%
Decreased appetite
9%
Alanine aminotransferase increased
9%
Nasopharyngitis
9%
Bronchitis
6%
Anaemia
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Rash
3%
Leukopenia
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
Myalgia
3%
Subdural haemorrhage
3%
Nausea
3%
Malaise
3%
White blood cell count decreased
3%
Tumour associated fever
3%
Upper respiratory tract infection
3%
Hypertension
3%
Pyrexia
3%
Dyspnoea
3%
Back pain
3%
Chest pain
3%
Haematemesis
3%
Hyperthyroidism
3%
Lymph gland infection
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab 400 mgExperimental Treatment1 Intervention
Participants with any advanced solid tumor that has failed at least one line of therapy and is Tumor- Mutational Burden-High (TMB-H), excluding participants with mismatch repair deficient (dMMR/MSI-H) tumors. The dosing regimen for this cohort will be 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to approximately 2 years of treatment).
Group II: Pembrolizumab 200 mgExperimental Treatment1 Intervention
Participants will receive pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years of treatment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,526 Total Patients Enrolled
2 Trials studying Mesothelioma
680 Patients Enrolled for Mesothelioma
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,059,062 Total Patients Enrolled
18 Trials studying Mesothelioma
2,308 Patients Enrolled for Mesothelioma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,135 Total Patients Enrolled
2 Trials studying Mesothelioma
680 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids or immunosuppressants in the last 7 days.I haven't had cancer treatment or still have side effects from the last one within the past 2 weeks.I have or had lung inflammation that needed steroids.I haven't had cancer in the last 2 years, except for certain skin cancers or cancers that were completely removed.You have a severe allergic reaction to pembrolizumab or any of its ingredients.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 confirmed by lab tests and is an advanced solid tumor.My cancer has worsened or I can't tolerate my current treatment.I can provide a sample of my tumor for the study.Your disease can be seen and measured on a medical scan.My organs are working well.I have not been in a clinical trial for a new treatment or device within the last 4 weeks.I agree to use birth control and not donate or store my eggs for 120 days after my last dose.I have not been in a study or taken drugs targeting immune system checkpoints.I have an active Hepatitis B or C infection.I have an active tuberculosis infection.I have active brain metastases or cancer in the lining of my brain.I have received an organ or tissue transplant from another person.I am currently being treated for an infection.You are expected to live for at least 3 more months.I have been diagnosed with a specific brain tumor in the brain stem.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab 400 mg
- Group 2: Pembrolizumab 200 mg
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.
In how many different medical facilities is this research project being conducted currently?
"Currently, this trial is open to recruitment at Call for Information (Investigational Site 0005) in Rockville, Massachusetts, Call for Information (Investigational Site 0207) in Boston, New jersey, and Call for Information (Investigational Site 0008) in New Brunswick, California. There are 11 other potential locations where this study could be conducted."
Answered by AI
Are patients being enrolled in this experiment right now?
"The study, which was originally posted on December 18th, 2015 is currently looking for participants. The listing was most recently updated on October 21st, 2020."
Answered by AI
Has pembrolizumab completed the necessary steps for FDA approval?
"Pembrolizumab's safety was rated a 2 because, while there is data indicating it is safe, there is no evidence that the medication is effective."
Answered by AI
What are the common conditions that pembrolizumab helps to alleviate?
"Pembrolizumab is most commonly used to treat various forms of cancer. However, it can also be effective in combination with other treatments for conditions like unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
Are there other pembrolizumab clinical trials that we can compare this one to?
"Pembrolizumab is being researched in 122 phase 3 clinical trials, with 1000 studies currently underway. The majority of these research projects are based in Houston, Texas; however, there are 36030 locations worldwide conducting pembrolizumab clinical trials."
Answered by AI
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