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PD-1 Inhibitor

Pembrolizumab 200 mg Q3W for Solid Tumors

Phase 2
Waitlist Available
Led By John P Diaz, MD
Research Sponsored by Baptist Health South Florida
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 3 years
Awards & highlights

Study Summary

This trial is testing whether the drug pembrolizumab can help patients with metastatic solid tumors who have not responded to other treatments.

Eligible Conditions
  • Solid Tumors, Adult

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Immune-related Objective Response Rate
Secondary outcome measures
Overall Response
Progression-free Survival (PFS)

Side effects data

From 2022 Phase 2 trial • 52 Patients • NCT03274661
25%
Fatigue
15%
Constipation
13%
Anorexia
13%
Nausea
10%
Anemia
10%
Elevated creatinine
10%
Dyspnea
10%
Abdominal pain
8%
Vomiting
8%
Abdominal discomfort
6%
Elevated lactate dehydrogenase
6%
Back pain
6%
Diarrhea
6%
Bloating
6%
Cough
6%
Insomnia
6%
Edema (leg)
4%
Ascites
4%
Intestinal obstruction
4%
Abdominal distension
2%
Obstruction - gastric
2%
Sepsis
2%
Urinary retention - Hydronephrosis
2%
Malaise
2%
Thromboembolic event
2%
Female genital tract fistula - rectovaginal fistula
2%
Dizziness
2%
Colonic obstruction
2%
Stroke
2%
Pelvic pain
2%
Hypercalcemia
2%
Pleural effusion
2%
Urinary retention - Urinary tract infection
2%
Fall
2%
Gastrointestinal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab 200 mg Q3W

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab 200 mg Q3WExperimental Treatment1 Intervention
Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab 200 mg Q3W
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,779 Total Patients Enrolled
Miami Cancer InstituteOTHER
5 Previous Clinical Trials
893 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,501 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03274661 — Phase 2
Solid Tumors Research Study Groups: Pembrolizumab 200 mg Q3W
Solid Tumors Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03274661 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03274661 — Phase 2

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 spots open for people who want to participate in this research?

"This study is not currently open for recruitment. However, it was last updated on 7/25/2022 and initially posted on 11/2/2017. There are 2510 other trials related to cancer and 1000 studies involving Pembrolizumab 200 mg Q3W that are actively seeking participants."

Answered by AI

Does this experiment allow for geriatric patients to participate?

"This clinical trial is only for patients that fall in the age bracket of 18 to 99 years old. Out of the 346 studies available for minors, this is one of the few options. And, there are 3,309 similar trials open to patients above 65."

Answered by AI

Are there any similar Pembrolizumab 200 mg Q3W trials that have taken place in the past?

"Pembrolizumab 200 mg Q3W is being trialed in 1000 active clinical studies, with 122 of those in Phase 3. Many of these trials are concentrated in Houston, Texas, but Pembrolizumab 200 mg Q3W is also being tested at 36030 other locations."

Answered by AI

How many total patients are part of this research project?

"Recruitment for this clinical trial has closed. The study was posted on 11/2/2017 and last updated over 4 years ago on 7/25/2022. However, there are plenty of other ongoing studies that might be of interest. There are 2510 active trials recruiting cancer patients and 1000 seeking participants for Pembrolizumab 200 mg Q3W."

Answered by AI

What therapeutic effect does Pembrolizumab 200 mg Q3W generally provide?

"Pembrolizumab 200 mg Q3W is a medication that is often used to treat malignant neoplasms. This drug can also be helpful in managing unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Who would be an ideal candidate to participate in this clinical trial?

"This study is looking for 50 individuals that have been diagnosed with cancer and are between 18-99 years old. Most importantly, patients must meet the following requirements: Be willing to provide consent for retrieval of archival tumor material tissue from a previously obtained core or excisional biopsy of a tumor lesion., Have a tumor presentation at screening for which pembrolizumab does not have an FDA approved indication for commercial use., Diagnosis of Endometrial Carcinoma or Sarcoma which is metastatic and has failed standard treatment or is recurrent, or for which standard chemotherapy is contraindicated or refused by patient.,"

Answered by AI

What have been the reported adverse effects of Pembrolizumab 200 mg Q3W?

"Pembrolizumab 200 mg Q3W received a 2 on our team's safety scale at Power. This is because, while there is data supporting its safety, there is currently no evidence that the medication is effective."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors
2017. "Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03274661.
~7 spots leftby Apr 2025
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