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Anti-tumor antibiotic

Pembrolizumab for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Michael Livingston, MD
Research Sponsored by Michael Livingston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be willing and able to provide written informed consent for the trial.
Must have at least one radiologically measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter or lymph node that is 15mm in short axis imaged by CT scan or MRI. Tumors with previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence of at least 90 days following completion of radiotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of response to date of progression/death, or censored as described above; assessed for approximately 2 years.
Awards & highlights

Study Summary

This trial will test if doxorubicin and pembrolizumab are safe and effective in treating soft tissue sarcoma.

Eligible Conditions
  • Soft Tissue Sarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With at Least One Severe or Life-Threatening Adverse Event
Secondary outcome measures
Duration of Response (DoR)
Number of Subjects With an Objective Response
Overall Survival (OS)
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + doxorubicinExperimental Treatment2 Interventions
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

Michael LivingstonLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,233 Previous Clinical Trials
1,001,789 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,867 Previous Clinical Trials
5,051,753 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 this experiment a pioneering endeavor?

"The foundation for researching Pembrolizumab was established in 1997, when Alfacell sponsored the initial clinical trial. After a successful Phase 3 approval process involving 300 patients, 1299 active trials of this drug are ongoing across 71 nations and 3388 cities worldwide."

Answered by AI

Has the regulatory agency sanctioned Pembrolizumab for official use?

"Despite the lack of efficacy data, our team gave Pembrolizumab a score of 2 out of 3 due to evidence that it is generally safe."

Answered by AI

What is the current enrollment size for this scientific research?

"Unfortunately, this trial is defunct and no longer collecting patients. It was first posted on May 1st 2017, with the final edits occurring on September 29th 2022. However, 443 additional trials for sarcoma are currently enrolling participants and 1299 studies related to Pembrolizumab have open recruitments at present."

Answered by AI

Is this clinical investigation open to enrollment currently?

"At the time of writing, this trial is not searching for new participants. It was initially posted on May 1st 2017 and last modified on September 29th 2022. However, there are over four hundred trials seeking enrolment from sarcoma patients and a total of one thousand two hundred ninety-nine studies that focus on pembrolizumab currently recruiting candidates."

Answered by AI

What other explorations have been conducted with regards to Pembrolizumab?

"Presently, 1299 active trials are examining the efficacy of Pembrolizumab with 236 being in Phase 3. The primary concentration for these studies is Houston, Texas; nevertheless, there are 58237 total sites conducting research on this drug."

Answered by AI

What afflictions has Pembrolizumab been demonstrated to alleviate?

"Pembrolizumab is a widely accepted therapy for unresectable melanoma. It has also been clinically shown to treat microsatellite instability high, neuroblastoma (nb), and cases with an elevated risk of relapse."

Answered by AI
~4 spots leftby Mar 2025