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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
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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
1,969 Previous Clinical Trials
597,308 Total Patients Enrolled
70 Trials studying Sarcoma
13,801 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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.
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