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Anti-tumor antibiotic
Pembrolizumab + Local Chemotherapy for Sarcoma
Phase 2
Recruiting
Led By Edmund Bartlett, 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
Eligible for standard treatment with pembrolizumab
Adequate performance status: ECOG </= 2 or KPS >/= 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether the drug pembrolizumab, when combined with two other chemotherapy drugs and delivered directly to an arm or leg, can safely delay disease progression.
Who is the study for?
This trial is for individuals aged 12 or older with advanced sarcoma in an arm or leg, who have tried at least one systemic therapy or declined standard care. They must be able to consent, follow the protocol, and have adequate organ function. Pregnant women, those planning pregnancy, and patients with certain health conditions like active infections or uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with chemotherapy drugs melphalan and dactinomycin delivered via isolated limb infusion (ILI) directly to the affected limb. The goal is to see if this approach safely delays disease progression compared to current treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation of organs, fatigue, skin changes at infusion site, nausea, blood count changes increasing infection risk; specific risks from ILI may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for pembrolizumab treatment.
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I am mostly independent in daily activities.
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I am 12 years old or older.
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My sarcoma is confirmed to be advanced or has spread.
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My blood and organ tests are within the required ranges for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with SarcomaExperimental Treatment3 Interventions
Advanced/metastatic extremity sarcoma eligible for pembrolizumab and isolated limb infusion (ILI)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,868 Total Patients Enrolled
70 Trials studying Sarcoma
13,737 Patients Enrolled for Sarcoma
Edmund Bartlett, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Sarcoma
10 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a candidate for pembrolizumab treatment.My blood and organ tests are within the required ranges for treatment.I am mostly independent in daily activities.I am 12 years old or older.My sarcoma is confirmed to be advanced or has spread.I have at least one tumor that can be measured for changes.You are not eligible if you have any of the following:
- Another cancer that needs to be treated
- Physical conditions that make you unable to receive ILI treatment, as determined by your doctor
- History of allergic reaction to pembrolizumab or any of its components
- Active infection that requires treatment or congestive heart failure in the last 6 months
- Known active brain metastases, except for those previously treated and stable
- Significant immunosuppression, such as primary immunodeficiency, opportunistic infection, or use of immunosuppressive therapy within 7 days before enrollment
- Active infections with HIV, hepatitis B or C, or tuberculosis
- History or evidence of autoimmune disease that has required systemic treatment in the past 2 years
- Pregnant or breastfeeding, planning to become pregnant, or planning to father a child during the study and for 4 months after the last dose of pembrolizumab
- Not willing to use contraception during the study and for 4 months after the last dose of pembrolizumab (if of childbearing potential)
- Received cancer treatment or major surgery within 14 days before the start of the study or has not recovered from treatment-related adverse events
- Currently participating in another study involving investigational drugs or devices, or participated in such a study within 3 weeks of starting this study
- Known psychiatric or substance abuse disorders that would interfere with participation in the study.My doctor has approved me for a procedure targeting only my limb.I have had or declined at least one standard cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Sarcoma
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of this research endeavor?
"Affirmative. Data available on clinicaltrials.gov confirm that this trial is currently recruiting participants, with the initial posting occurring on April 1st 2020 and most recent update taking place November 21st 2022. The research team needs to enlist around 30 individuals from 10 distinct medical facilities."
Answered by AI
Are there any historical precedents of utilizing Pembrolizumab in clinical experiments?
"Discovered in 1997 by City of Hope Comprehensive Cancer Center, pembrolizumab has gone through 482 clinical trials. Currently 1083 live studies are being conducted with a sizable cohort located in Harrison, New york."
Answered by AI
Are there any vacancies for potential participants in this medical experiment?
"The investigation, whose initial advertisement went up on the 1st of April 2020 is still seeking participants. Information featured on clinicaltrials.gov was recently updated on November 21 2022."
Answered by AI
What risk factors are associated with Pembrolizumab treatments?
"Due to the Phase 2 status of this clinical trial, our team assigns Pembrolizumab a score of two - reflecting prior data supporting its safety but not efficacy."
Answered by AI
In what geographic areas is the investigation currently taking place?
"Ten trial sites are enrolling patients, with two of the most notable being Memorial Sloan Kettering Westchester (Limited Protocol Activities) in Harrison and Memorial Sloan Kettering Basking Ridge (Limited protocol activities) in Basking Ridge. Eight other locations have also been approved for patient recruitment."
Answered by AI
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