Anti-tumor antibiotic

Pembrolizumab for Sarcoma

Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge, NJ
Targeting 4 different conditionsPembrolizumab +2 morePhase 2RecruitingLed by Edmund Bartlett, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

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.

Eligible Conditions
  • Sarcoma
  • Myxofibrosarcoma
  • Pleomorphic Sarcoma
  • Alveolar Soft Part Sarcoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are able to receive the standard treatment with pembrolizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Aspartate aminotransferase increased
9%
Hyponatraemia
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
7%
Febrile neutropenia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Musculoskeletal chest pain
5%
Pain in extremity
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
2%
Atrial fibrillation
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Hemiparesis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

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.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 site

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,892 Previous Clinical Trials
587,110 Total Patients Enrolled
67 Trials studying Sarcoma
13,268 Patients Enrolled for Sarcoma
Edmund Bartlett, MDPrincipal Investigator
Memorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Sarcoma
10 Patients Enrolled for Sarcoma

Media Library

Dactinomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04332874 — Phase 2
Sarcoma Research Study Groups: Participants with Sarcoma
Sarcoma Clinical Trial 2023: Dactinomycin Highlights & Side Effects. Trial Name: NCT04332874 — Phase 2
Dactinomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332874 — Phase 2

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

What conditions have been effectively remedied by Pembrolizumab?

"Pembrolizumab is frequently utilized to address unresectable melanoma, as well as microsatellite instability high, sarcoma, and conditions with a heightened risk of relapse."

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
~3 spots leftby Apr 2024