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PD-1 Inhibitor

Pembrolizumab + Radiotherapy for Soft Tissue Sarcoma (SU2C-SARC032 Trial)

Phase 2
Waitlist Available
Led By David Kirsch, MD, PhD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 12 years
Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or dedifferentiated/pleomorphic LPS of the extremity that measures greater than 5 cm in any direction as assessed by imaging
Must not have
Received a live vaccine within 30 days of planned start of study therapy
Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for people aged 12 or older with high-risk soft tissue sarcoma of the extremity that's larger than 5 cm and hasn't spread. Participants must be in good health, have no other active cancers, not had major surgery recently, and agree to use birth control. Those with autoimmune diseases, infections needing treatment, HIV/Hepatitis B/C, or who are pregnant/nursing can't join.
What is being tested?
The study compares two treatments: one group receives radiotherapy followed by surgery; the other gets a drug called Pembrolizumab with radiotherapy before surgery and continues Pembrolizumab for a year after. It aims to see if adding Pembrolizumab helps more than just radiotherapy and surgery alone.
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in organs (including lungs), skin reactions, hormone gland problems (like thyroid issues), infusion reactions during administration, fatigue, digestive issues such as diarrhea or liver inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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My cancer is a specific type and grade, and it's larger than 5 cm.
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My cancer has not spread and can be surgically removed.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 30 days.
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I have had pneumonitis treated with steroids or have it now.
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I am currently on medication for an infection.
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I have an active Hepatitis B or C infection.
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I have been diagnosed with scleroderma.
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I have been diagnosed with inflammatory bowel disease.
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I am scheduled for chemotherapy before or after surgery for my localized soft tissue sarcoma.
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I have been treated for an autoimmune disease in the last two years.
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My sarcoma site has not received more than 20 Gy of radiation.
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I haven't had major surgery in the last 4 weeks or I've fully recovered from recent surgery.
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I have an active tuberculosis infection.
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I have received chemotherapy, targeted therapy, or radiation for my current sarcoma diagnosis.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have been diagnosed with HIV.
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My condition cannot be treated with surgery.
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I have not had any other serious cancers in the last two years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease free survival
Secondary study objectives
Distant disease free survival
Loco-regional disease-free survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab.
Group II: Standard of CareActive Control1 Intervention
Neoadjuvant radiotherapy followed by surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,677 Total Patients Enrolled
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,828 Total Patients Enrolled
Stand Up To CancerOTHER
52 Previous Clinical Trials
39,995 Total Patients Enrolled
David Kirsch, MD, PhDPrincipal InvestigatorPrincess Margaret Cancer Center

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03092323 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Standard of Care, Treatment
Soft Tissue Sarcoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03092323 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03092323 — Phase 2
~10 spots leftby Sep 2025
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