Pembrolizumab + Radiotherapy for Soft Tissue Sarcoma
(SU2C-SARC032 Trial)
Trial Summary
What is the purpose of this trial?
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any form of immunosuppressive therapy, you may need to stop these at least 7 days before starting the trial treatment.
What data supports the effectiveness of the drug pembrolizumab for soft tissue sarcoma?
Research shows that pembrolizumab, a drug that helps the immune system fight cancer, had a 17.5% response rate in patients with advanced sarcoma, particularly in certain types like undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. This suggests it may help some patients with these specific sarcoma types.12345
Is pembrolizumab safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been used in various clinical trials and is generally considered safe for humans, though it can cause side effects like fatigue, cough, nausea, and immune-related issues such as thyroid problems and lung inflammation. It has been approved for use in conditions like melanoma, indicating that its benefits outweigh the risks in certain serious diseases.13456
How is the drug pembrolizumab combined with radiotherapy unique for treating soft tissue sarcoma?
Pembrolizumab is a drug that helps the immune system fight cancer by blocking a protein called PD-1, which can stop the immune system from attacking cancer cells. When combined with radiotherapy, which can also affect the immune system, this treatment may enhance the body's ability to fight soft tissue sarcoma, offering a novel approach compared to traditional chemotherapy.13578
Research Team
David Kirsch, MD, PhD
Principal Investigator
Princess Margaret Cancer Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Neoadjuvant pembrolizumab with concurrent radiotherapy followed by surgical resection
Adjuvant Treatment
Up to fourteen cycles of adjuvant pembrolizumab after surgical resection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarcoma Alliance for Research through Collaboration
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Stand Up To Cancer
Collaborator