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Checkpoint Inhibitor

Pembrolizumab for Soft Tissue Sarcoma

Phase 1 & 2

Waitlist Available

Led By Lee Cranmer

Research Sponsored by Fred Hutchinson Cancer Center

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 through the wound care follow-up visit (up to 8 months)

Awards & highlights

Study Summary

This trial is studying pembrolizumab with radiation therapy to see if it can better treat patients with soft tissue sarcoma.

Eligible Conditions

Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the wound care follow-up visit (up to 8 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the wound care follow-up visit (up to 8 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the wound care follow-up visit (up to 8 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

Rate of complete tumor necrosis

Secondary outcome measures

Incidence of adverse events

Partial Response Rate

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, radiation therapy)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Pembrolizumab

2017

Completed Phase 2

~2010

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Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,526 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,241 Total Patients Enrolled

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,218 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this trial?

"Affirmative. Clinicaltrials.gov displays that this clinical study is recruiting participants, having been initially posted on 28th March 2018 and last edited 18th October 2022. 26 patients are required at a single clinic location."

Answered by AI

In what situations is Pembrolizumab commonly used?

"Pembrolizumab is mainly used to treat malignancies, but has also been observed to be effective in certain cases of unresectable melanoma, microsatellite instability high and cancer progression following chemotherapy."

Answered by AI

What is the aggregate patient population enrolled in this clinical experiment?

"Affirmative. According to the information in clinicaltrials.gov, this medical study is actively looking for participants from a single site and has set an enrolment goal of 26 people. This trial was first created on March 28th 2018 and its details were most recently updated on October 18th 2022."

Answered by AI

Could you provide a synopsis of the past experiments conducted with Pembrolizumab?

"Presently, there are 961 trials in effect for Pembrolizumab with 122 of them being Phase 3. Although Houston, Texas hosts the most studies for this medication, across the globe 35731 sites are actively researching it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma

2018. "Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03338959.