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Monoclonal Antibodies

Pembrolizumab for Fast-Growing Cancers

Phase 2
Waitlist Available
Led By Dung Le, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with colon cancer must have received at least two prior cancer therapy regimens.
Patients with microsatellite stable tumor and a tumor mutation burden (TMB) level measured at > 20 mutations per megabase pairs (MB)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will be testing whether an antibody that blocks negative signals to T cells can help treat patients with a type of cancer that is known to grow and spread quickly.

Who is the study for?
This trial is for patients with microsatellite stable tumors and high tumor mutation burden (>20 mutations/MB). They must have received prior cancer therapy, be in good physical condition (ECOG 0-1), have proper organ function, agree to use birth control, consent to biopsies, and not have certain health issues or recent treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests MK-3475 (pembrolizumab) effectiveness and safety in patients whose cancers are MSI-negative but show a mutator phenotype. It aims to see if this drug can shrink or slow the growth of these specific types of tumors.See study design
What are the potential side effects?
While not specified here, pembrolizumab may cause immune-related side effects such as fatigue, skin reactions, diarrhea/colitis, liver inflammation, hormone gland problems (like thyroid dysfunction), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have colon cancer and have undergone at least two treatments.
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My tumor is stable and has a high number of mutations.
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I agree to undergo a biopsy of my cancer.
Select...
I have had at least one treatment for my cancer.
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My condition is getting worse.
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I am fully active or can carry out light work.
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My organ functions are within normal ranges according to specific tests.
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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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) in Patients With MSI (Microsatellite Unstable)-Negative Solid Tumor Malignancies With a Mutator Phenotype
Secondary outcome measures
Disease Control Rate (DCR)
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Overall Survival (OS)
+1 more

Side effects data

From 2020 Phase 2 trial • 65 Patients • NCT02085070
83%
Fatigue
62%
Cough
50%
Constipation
50%
Dyspnea
43%
Back pain
40%
Anorexia
36%
Headache
33%
Diarrhea
31%
Pain in extremity
29%
Nausea
24%
Rash maculo-papular
24%
Dizziness
24%
Edema limbs
21%
Anxiety
17%
Insomnia
17%
Hypertension
14%
Abdominal pain
14%
Thromboembolic event
14%
Hypothyroidism
12%
Non-cardiac chest pain
12%
Pruritus
12%
Allergic rhinitis
10%
Vomiting
10%
Pain
10%
Muscle weakness lower limb
10%
Floaters
7%
Gastroesophageal reflux disease
7%
Dyspepsia
7%
Aspartate aminotransferase increased
7%
Fever
7%
Arthralgia
7%
Neck pain
7%
Chest wall pain
7%
Depression
7%
Creatinine increased
7%
Bone pain
7%
Seizure
7%
Alanine aminotransferase increased
5%
Cognitive disturbance
5%
Pneumonitis
5%
Nasal congestion
2%
Chills
2%
Adrenal Insufficienvy
2%
Acute Kidney Injury
2%
Hypokalemia
2%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-small Cell Lung Cancer Patients
Melanoma Patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: MSI (Microsatellite Unstable) Negative with Mutator PhenotypeExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-3475
2014
Completed Phase 2
~1290

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,682 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,888 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
12 Previous Clinical Trials
622 Total Patients Enrolled

Media Library

MK-3475 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04098068 — Phase 2
MK-3475 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098068 — Phase 2
Tumor Mutation Burden Research Study Groups: MSI (Microsatellite Unstable) Negative with Mutator Phenotype
Tumor Mutation Burden Clinical Trial 2023: MK-3475 Highlights & Side Effects. Trial Name: NCT04098068 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential side effects has MK-3475 demonstrated in clinical trials?

"Considering the Phase 2 status of MK-3475 (a monoclonal antibody that interferes with negative signalling to T cells), our team assigned it a score of 2 on the safety scale. This is due to there being some evidence in support of its safety but no data showing efficacy."

Answered by AI

Is enrollment still open for the current research project?

"According to clinicaltrials.gov, this medical trial is no longer enrolling participants after being posted on the 25th of January 2018 and updated March 3rd 2022. Nonetheless, there are 3335 other trials currently open for recruitment in its place."

Answered by AI

What is the sample size of this therapeutic investigation?

"This clinical trial is not presently accruing patients. As of March 3rd 2022, the most recent edit to the study was made on January 25th 2018. For those seeking other research opportunities, there are 2374 cancer studies and 961 MK-3475 (an Antibody That Blocks Negative Signals to T Cells) related trials actively recruiting participants."

Answered by AI

Have any prior investigations explored the efficacy of MK-3475 as an inhibitor of inhibitory signals to T Cells?

"Currently, 961 studies involving MK-3475 (an Antibody That Blocks Negative Signals to T Cells) are underway with 122 of these trials in their terminal phase. While numerous research institutes in Houston, Texas have launched investigations into this antibody, there are 35727 sites across the globe engaging in related research."

Answered by AI

How many medical centers are currently offering this trial?

"Seven medical sites are enrolling participants for this trial, with Ohio State University in Columbus, Memorial Sloan Kettering Cancer Center in New york City, and Dana-Farber Cancer Institute in Boston being the most prominent. Additionally there are 4 other clinical hubs taking part."

Answered by AI

For what maladies is MK-3475 (an Antibody That Blocks Negative Signals to T Cells) commonly administered?

"MK-3475, an antibody that prevents the inhibition of T cells, can be used to treat malignant neoplasms, inoperable melanomas and microsatellite instability high cases."

Answered by AI
~2 spots leftby Apr 2025