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Pembrolizumab for Soft Tissue Sarcoma

University of Iowa Hospitals & Clinics, Iowa City, IA
Soft Tissue SarcomaPembrolizumab - Drug
Eligibility
Any Age
All Sexes

Study Summary

This trial is comparing two different treatments for cancer. One treatment is standard radiotherapy followed by surgery. The other treatment is a new immunotherapy drug called pembrolizumab, given before and after radiotherapy and surgery.

Eligible Conditions
  • Soft Tissue Sarcoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
Pembrolizumab
1
Pembrolizumab
1
Pembrolizumab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 5 years

2 Years
Disease free survival
5 years
Distant disease free survival
Loco-regional disease-free survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Pembrolizumab
2
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2
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Side Effects for

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

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new 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

2 Treatment Groups

Standard of Care
1 of 2
Treatment
1 of 2

Active Control

Experimental Treatment

126 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment
Drug
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,737 Previous Clinical Trials
4,973,773 Total Patients Enrolled
Sarcoma Alliance for Research through CollaborationLead Sponsor
24 Previous Clinical Trials
1,788 Total Patients Enrolled
Stand Up To CancerOTHER
47 Previous Clinical Trials
41,339 Total Patients Enrolled
David Kirsch, MD, PhDPrincipal InvestigatorDuke University

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate if you have non-serious skin cancer, in situ carcinoma, or low-risk prostate cancer.
References

Frequently Asked Questions

What is the cap on participants for this clinical experiment?

"To successfully carry out this medical trial, 126 eligible patients must be enlisted. Merck Sharp & Dohme LLC is running the study from various locations including The Ohio State University and Johns Hopkins University." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to enroll in this experiment?

"Affirmative. According to the information recorded on clinicaltrials.gov, this trial is actively seeking volunteers and has been since July 19th 2017. The latest update was made March 25th 2022 and 126 patients are needed from 12 sites in total." - Anonymous Online Contributor

Unverified Answer

In which localities is this experiment being administered?

"This medical study has 15 total sites, with The Ohio State University in Columbus, Johns Hopkins University in Baltimore, and Duke University in Durham being three among them." - Anonymous Online Contributor

Unverified Answer

What has been the primary application of Pembrolizumab?

"Pembrolizumab is frequently employed to treat cancerous neoplasms and has been used with some success in cases of unresectable melanoma, microsatellite instability high, or those who have experienced disease progression after chemotherapy." - Anonymous Online Contributor

Unverified Answer

To what extent do the risks of Pembrolizumab outweigh its potential benefits?

"Based on the existing data, there is an assessment that pembrolizumab's safety can be rated a 2. This rating reflects their being clinical evidence for its safety but not efficacy due to it only being in Phase 2 of trials." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab been the subject of prior investigations?

"Pembrolizumab was initially researched at City of Hope in 2010, with 251 trials having been concluded since then. Currently, there are 961 active clinical studies being conducted across the US, many located in Columbus, Ohio." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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