Immunotherapy Combined With Radiotherapy for Metastatic Sarcoma (NCT05488366)
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a pilot study determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (13 items).
Location: Chao Family Comprehensive Cancer Center, University of California, Irvine โ Orange, California
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 2 weeks prior to initiation of study therapy.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy administered.
- Patients must not be receiving any other investigational agents.
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Pembrolizumab can cause fetal harm when administered to a pregnant woman based on the biological mechanism that PD-1/PD-L1 signaling is an important pathway in the maintenance of pregnancy through induction of maternal immune tolerance to fetal tissue.1 Human IgG4 is known to cross the placenta. Animal models have found that blocking PD-L1 signaling increases the risk of fetal loss, and immune-mediated disorders occurred in PD-1 knockout mice.
- Although there are not data on the presence of pembrolizumab in either animal or human milk or its effects on breastfed children or on milk production, there is a potential for serious adverse reactions in breastfed children. Thus, women are advised not to breastfeed during treatment with pembrolizumab and for 120 days after the final dose.
- Patients with disease amenable to curative intent surgery.
- Patient has had a prior monoclonal antibody for treatment of sarcoma, unless the current regimen is checkpoint inhibitor immunotherapy.
- Patient has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Chao Family Comprehensive Cancer Center, University of California, Irvine โ Orange, California
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.