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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
SU2C-SARC032 Trial 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.Check my eligibility
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.See study design
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.
SU2C-SARC032 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My cancer has not spread and can be surgically removed.
Select...
I am fully active or can carry out light work.
SU2C-SARC032 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival
Secondary outcome measures
Distant disease free survival
Loco-regional disease-free survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
SU2C-SARC032 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 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,427 Total Patients Enrolled
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,828 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I have had pneumonitis treated with steroids or have it now.I am currently on medication for an infection.I have an active Hepatitis B or C infection.I have been diagnosed with scleroderma.My cancer has spread or is in my lymph nodes, but I may still qualify based on specific scan results.I am scheduled for chemotherapy before or after surgery for my localized soft tissue sarcoma.I have been treated for an autoimmune disease in the last two years.My cancer is a specific type and grade, and it's larger than 5 cm.My cancer has not spread and can be surgically removed.My organs are functioning well, as tested within the last 10 days.My sarcoma site has not received more than 20 Gy of radiation.My sarcoma has come back in the same place after surgery but I meet other study requirements.I haven't had major surgery in the last 4 weeks or I've fully recovered from recent surgery.I am not currently on a study drug or haven't been in the last 4 weeks.I have an active tuberculosis infection.I have been diagnosed with inflammatory bowel disease.I am 12 years old or older.I have a type of skin cancer, in situ carcinoma, or low-risk prostate cancer.I agree to use birth control during and for 120 days after my treatment, and I have a negative pregnancy test if I'm a woman of childbearing age.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have received chemotherapy, targeted therapy, or radiation for my current sarcoma diagnosis.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have been diagnosed with HIV.I am fully active or can carry out light work.My condition cannot be treated with surgery.I have not had any other serious cancers in the last two years.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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