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Pembrolizumab for Solid Cancers

Phase < 1
Recruiting
Led By Yelena Janjigian, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing if pembrolizumab is safe and effective in preventing cancer recurrence in people who have had surgery to remove a solid tumor.

Who is the study for?
Adults who've had surgery to remove a solid tumor with high microsatellite instability (MSI-H) and still have cancer cells in their blood. They must have completed standard cancer treatments, be generally healthy with good organ function, and not be on immunosuppressive drugs. People can't join if they're pregnant, breastfeeding, or have active infections like TB or hepatitis.Check my eligibility
What is being tested?
The trial is testing pembrolizumab's effectiveness at preventing cancer recurrence after surgery compared to a placebo. Participants will receive the drug or placebo for up to 12 months unless the cancer returns or side effects become too severe.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation of organs, skin reactions, hormone gland problems (like thyroid), lung issues (pneumonitis), infusion reactions, fatigue, and possibly increase infection risk.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
proportion of patients with ctDNA clearance
Secondary outcome measures
disease free survival (DFS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab 200 mg IV every 3 weeks over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,968 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,358 Total Patients Enrolled
Yelena Janjigian, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
1,052 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03832569 — Phase < 1
Molecular Diagnostics Research Study Groups: Pembrolizumab
Molecular Diagnostics Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03832569 — Phase < 1
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03832569 — Phase < 1

Frequently Asked Questions

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

Are there any more places available for people in this clinical trial?

"That is accurate. The clinical trial, which was first posted on February 20th, 2019, is still recruiting patients according to the information available on clinicaltrials.gov. There are 9 sites enrolling a total of 10 patients."

Answered by AI

Are there other precedents for using Pembrolizumab in medical trials?

"Pembrolizumab was first studied a decade ago at City of Hope. As of now, there are 248 completed studies and 1000 ongoing clinical trials concerning this medication. A great deal of these studies are based in Middletown, New york."

Answered by AI

For what illnesses is Pembrolizumab most often prescribed?

"Pembrolizumab is a medication that oncologists often prescribe to treat different types of cancer. It can also be used to manage microsatellite instability high and disease progression after chemotherapy in patients that have unresectable melanoma."

Answered by AI

Where are the different places this trial is being conducted?

"According to the latest information, 9 sites are running this trial. 3 of these are Memorial Sloan Kettering locations in Middletown, Uniondale, and Montvale. The other 6 clinical trial sites are based in various other locations."

Answered by AI
Recent research and studies
~3 spots leftby Feb 2025