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Checkpoint Inhibitor
Pembrolizumab + Radiotherapy for Sarcoma
Phase < 1
Recruiting
Led By Jeremy Harris, MD, MPhil
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed soft-tissue sarcoma, or a soft-tissue sarcoma with tumor mutational burden ≥10 mut/Mb
Must not have disease amenable to curative intent surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination treatment for people with a type of cancer that has spread or come back and can't be cured with surgery.
Who is the study for?
Adults with advanced or recurrent soft-tissue sarcoma, not eligible for curative surgery. Must have measurable lesions, life expectancy over 3 months, and proper organ/marrow function. HIV-positive patients can join if viral load is undetectable. Excludes pregnant/nursing women, those on active immunosuppression, with recent chemotherapy/radiotherapy or other investigational agents.Check my eligibility
What is being tested?
The trial tests the combination of pembrolizumab (an immunotherapy drug) and stereotactic ablative radiotherapy (SBRT) in treating metastatic sarcoma. It aims to see if this combo is feasible for patients who've had previous systemic therapy or are ineligible for it.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormonal gland problems leading to hormone deficiencies, infusion reactions and potential harm to a fetus; SBRT might cause localized pain or skin changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of sarcoma with a high number of mutations.
Select...
My condition cannot be cured with surgery.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility, measured as the number of patients completing treatment.
Secondary outcome measures
Duration of response
Local failure at the irradiated site
Number of grade 3-5 adverse events
+6 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
Trial Design
2Treatment groups
Experimental Treatment
Group I: B: Radiation Therapy with or without standard of care checkpoint inhibitor immunotherapyExperimental Treatment1 Intervention
Patients who are currently receiving a checkpoint inhibitor immunotherapy regimen will be allowed to continue their regimen at their treating oncologist's discretion. Radiation therapy will be delivered in 1 to 10 fractions starting on Day 1.
Group II: A: Pembrolizumab + Radiation TherapyExperimental Treatment2 Interventions
Patients receive pembrolizumab 400 mg intravenous every 42 days; Radiation therapy in 1 to 10 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,989 Total Patients Enrolled
Jeremy Harris, MD, MPhilPrincipal InvestigatorUniversity of California, Irvine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HBV or HCV but my viral load is undetectable or I am on suppressive therapy.My condition can potentially be cured with surgery.I have another cancer besides skin cancer that is getting worse or needs treatment.My cancer is a type of sarcoma with a high number of mutations.I haven't taken any immunosuppressive drugs in the last week.My condition cannot be cured with surgery.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My recent tests show my organs and bone marrow are working well.I haven't had chemotherapy or radiotherapy in the last 2 weeks.My soft-tissue sarcoma is advanced or has returned and I've had or can't have first-line treatment.I started immunotherapy within the last 60 days or my sarcoma type responds to pembrolizumab.I have a tumor outside the brain that can be treated with radiation, and if previously radiated, it was done safely and over 6 months ago.I have received a monoclonal antibody for sarcoma, but am now on checkpoint inhibitor immunotherapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have an autoimmune disease but it's either mild or treated with minimal medication.I have at least 2 tumors that can be measured by a CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: B: Radiation Therapy with or without standard of care checkpoint inhibitor immunotherapy
- Group 2: A: Pembrolizumab + Radiation Therapy
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.
Does this research project still have openings for participants?
"Data hosted on clinicaltrials.gov affirms that this medical trial is actively searching for suitable patients. It was initially posted on August 3rd 2022 and the latest update was issued on August 9th of the same year."
Answered by AI
How many individuals have been recruited to take part in this research?
"Indeed, records on clinicaltrials.gov demonstrate that this medical trial is still looking for volunteers to take part in the research; it was posted on August 3rd 2022 and last updated on August 9th 2022. The study requires 12 participants from 1 site."
Answered by AI
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