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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 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 can provide a sample of my tumor for the study.
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My organs are working well.
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I agree to use birth control and not donate or store my eggs for 120 days after my last dose.
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I am fully active or restricted in physically strenuous activity but can do light work.

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%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Arthralgia
9%
Decreased appetite
9%
Diarrhoea
9%
Constipation
9%
Haemoptysis
9%
Hypothyroidism
9%
Nasopharyngitis
9%
Bronchitis
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Anaemia
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Malaise
3%
Hyperglycaemia
3%
Pyrexia
3%
White blood cell count decreased
3%
Hypertension
3%
Back pain
3%
Hyperthyroidism
3%
Upper respiratory tract infection
3%
Dyspnoea
3%
Myalgia
3%
Leukopenia
3%
Chest pain
3%
Nausea
3%
Rash
3%
Tumour associated fever
3%
Haematemesis
3%
Pneumonia bacterial
3%
Subdural haemorrhage
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
4,580,213 Total Patients Enrolled
2 Trials studying Mesothelioma
680 Patients Enrolled for Mesothelioma
Merck Sharp & Dohme LLCLead Sponsor
3,884 Previous Clinical Trials
5,052,777 Total Patients Enrolled
18 Trials studying Mesothelioma
2,308 Patients Enrolled for Mesothelioma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,061,871 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

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
Recent research and studies
~362 spots leftby Oct 2026