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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible for standard treatment with pembrolizumab

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up6 months

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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

Select...

You are able to receive the standard treatment with pembrolizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Aspartate aminotransferase increased

Hyponatraemia

Pneumonia

Oedema peripheral

Upper respiratory tract infection

Alanine aminotransferase increased

Abdominal pain

Blood creatinine increased

Hypokalaemia

Febrile neutropenia

Abdominal pain upper

Stomatitis

Dry skin

Erythema

Dysgeusia

Hyperthyroidism

Dyspepsia

Dysphagia

Nasopharyngitis

Blood alkaline phosphatase increased

Musculoskeletal chest pain

Pain in extremity

Musculoskeletal pain

Chest pain

Hypertension

Hypotension

Urinary tract infection

Death

Acute kidney injury

Pneumonitis

Pulmonary embolism

Atrial fibrillation

Clostridium difficile colitis

Neutropenic sepsis

Pleural infection

Sepsis

Infusion related reaction

Diabetes mellitus

Aortic aneurysm

Inappropriate antidiuretic hormone secretion

Pneumothorax

Transient ischaemic attack

Gastritis

Hemiparesis

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

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

Recent research and studies

Frontiers in OncologyJournal

Case Report: Response to Regional Melphalan via Limb Infusion and Systemic PD1 Blockade in Recurrent Myxofibrosarcoma: A Report of 2 Cases

Bartlett, Edmund K., Sandra P. D’Angelo, Ciara M. Kelly, Robert H. Siegelbaum, Charles Fisher, Cristina R. Antonescu, and Charlotte E. Ariyan. 2021. “Case Report: Response to Regional Melphalan via Limb Infusion and Systemic PD1 Blockade in Recurrent Myxofibrosarcoma: A Report of 2 Cases”. Frontiers in Oncology. Frontiers Media SA. doi:10.3389/fonc.2021.725484.

clinicaltrials.govStudy

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

2020. "A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04332874.

All > Sarcoma