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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
Must not have
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from adverse events caused by a previously administered agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10.5 years
Awards & highlights

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 below
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My cancer is confirmed by lab tests and is an advanced solid tumor.
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My cancer has worsened or I can't tolerate my current treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken steroids or immunosuppressants in the last 7 days.
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I haven't had cancer treatment or still have side effects from the last one within the past 2 weeks.
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I have or had lung inflammation that needed steroids.
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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.
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I have not received a live vaccine in the last 30 days.
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I have active brain metastases or cancer in the lining of my brain.
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I have not been in a study or taken drugs targeting immune system checkpoints.
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I have an active Hepatitis B or C infection.
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I have an active tuberculosis infection.
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I have received an organ or tissue transplant from another person.
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I am currently being treated for an infection.
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I have been diagnosed with a specific brain tumor in the brain stem.
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I have been diagnosed with HIV.
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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 10.5 years for reporting.

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 more

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Arthralgia
9%
Bronchitis
9%
Diarrhoea
9%
Hypothyroidism
9%
Decreased appetite
9%
Constipation
9%
Haemoptysis
9%
Nasopharyngitis
9%
Aspartate aminotransferase increased
9%
Alanine aminotransferase increased
6%
Asthenia
6%
Cough
6%
Headache
6%
Anaemia
6%
Pruritus
6%
Pneumonia
6%
Blood alkaline phosphatase increased
3%
Lymph gland infection
3%
Hyperthyroidism
3%
Dyspnoea
3%
Malaise
3%
Pneumonia bacterial
3%
Upper gastrointestinal haemorrhage
3%
Upper respiratory tract infection
3%
Rash
3%
Hypertension
3%
Pyrexia
3%
Subdural haemorrhage
3%
White blood cell count decreased
3%
Back pain
3%
Chest pain
3%
Haematemesis
3%
Myalgia
3%
Hyperglycaemia
3%
Tumour associated fever
3%
Nausea
3%
Leukopenia
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
4,580,403 Total Patients Enrolled
2 Trials studying Mesothelioma
680 Patients Enrolled for Mesothelioma
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,066,654 Total Patients Enrolled
18 Trials studying Mesothelioma
2,308 Patients Enrolled for Mesothelioma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,068,721 Total Patients Enrolled
2 Trials studying Mesothelioma
680 Patients Enrolled for Mesothelioma

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02628067 — Phase 2
Mesothelioma Research Study Groups: Pembrolizumab 400 mg, Pembrolizumab 200 mg
Mesothelioma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02628067 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02628067 — Phase 2
~390 spots leftby May 2027
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