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PD-1 Inhibitor
Pembrolizumab + SBRT for Advanced Cancer
Phase 1
Waitlist Available
Led By Steven Chmura, M.D.
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older
Have measurable disease based on RECIST 1.1 including at least two tumor lesions that meet criteria for multi-organ site ablative radiation therapy (MOSART) SBRT radiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will look at whether combining radiation and pembrolizumab is safe for treating advanced solid tumors, and if it can make tumors shrink.
Who is the study for?
Adults with advanced solid tumors not treatable by cure, who've tried all standard treatments. They must have good organ function, a life expectancy of at least 6 months, and agree to use contraception. Specific criteria include having certain blood cell counts and tumor sizes suitable for SBRT. Not eligible if on high-dose steroids, have active infections or autoimmune diseases, are pregnant/breastfeeding, or recently used investigational drugs.Check my eligibility
What is being tested?
The trial is testing the safety of combining SBRT with pembrolizumab in patients with advanced solid tumors. It aims to find safe radiation doses for different organs when used alongside pembrolizumab and observe changes in the tumor post-SBRT.See study design
What are the potential side effects?
Possible side effects include inflammation in various organs due to immune response from pembrolizumab; skin reactions or fatigue from radiotherapy; potential complications from biopsies required during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have at least two tumors that can be measured and treated with specific radiation therapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has spread to my lungs, liver, bones, or abdomen.
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My kidney function, measured by creatinine levels, is within the normal range.
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My liver enzymes are within the required range.
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My cancer cannot be cured with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stereotactic Body Radiotherapy
Secondary outcome measures
Changes in tumor microenvironment caused by radiation treatment
Effect of combining radiation and pembrolizumab on local and distant tumor control
Effect of radiation and pembrolizumab on tumor control for lesions larger than 65cc
+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
3Treatment groups
Experimental Treatment
Group I: Oligometastatic CohortExperimental Treatment2 Interventions
Patients with few tumors (4 or less) will be enrolled and their tumors treated with (stereotactic body radiotherapy) given over 1 week followed by treatment with pembrolizumab. Pembrolizumab dosing will continue for up to 2 years or until patients have disease progression or unacceptable side effects.
Group II: Large Volume Tumors CohortExperimental Treatment2 Interventions
Patients with large tumors will be enrolled and their tumors will be partially treated with (stereotactic body radiotherapy) given over 1 week followed by treatment with pembrolizumab. Pembrolizumab dosing will continue for up to 2 years or until patients have disease progression or unacceptable side effects.
Group III: Dose Escalation CohortExperimental Treatment2 Interventions
Patients will be enrolled to receive specific doses of radiation (stereotactic body radiotherapy) given over 1 week followed by treatment with pembrolizumab. Pembrolizumab dosing will continue for up to 2 years or until patients have disease progression or unacceptable side effects. Enrollment will continue until best safe dose of SBRT is determined for each organ type.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy (SBRT)
2015
Completed Phase 1
~50
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,003 Previous Clinical Trials
819,632 Total Patients Enrolled
Steven Chmura, M.D.Principal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I've had radiation therapy before in the area where SBRT is planned.I am 18 years old or older.I have an active tuberculosis infection.I have not been in a clinical trial for a new treatment or device in the last 4 weeks.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.I have stable brain metastases, not on steroids for 7 days, and no carcinomatous meningitis.My cancer has spread to my lungs, liver, bones, or abdomen.I am using two birth control methods or am not having sex to avoid pregnancy during and after the study.I have an immune system disorder or am taking more than 10 mg of Prednisone daily.My cancer has spread, but only to 4 or fewer places that can be treated with targeted radiation.My organs are functioning well.I have recovered from any major surgery before starting treatment.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.I have interstitial lung disease.I have had lung inflammation treated with steroids or currently have it.I have tried all standard treatments for my NSCLC, including EGFR and ALK testing.I have at least two tumors that can be measured and treated with specific radiation therapy.My tumor is between 0.25 cc and 65 cc in size, or part of it can be treated if it's larger.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine in the last 30 days.I am willing to have more than one biopsy if my tumor is accessible and safe to do so.I have only received the flu shot, not the nasal spray vaccine.I have another cancer besides skin or in situ cervical cancer that needs treatment.I do not have active Hepatitis B or C.My kidney function, measured by creatinine levels, is within the normal range.My liver enzymes are within the required range.I agree to use birth control during and for 4 months after the study.My cancer cannot be cured with surgery or radiation.I have mild to moderate nerve pain or damage but can still qualify for the study.I am currently being treated for an infection.I have a tumor larger than 5cm that can be partially irradiated.
Research Study Groups:
This trial has the following groups:- Group 1: Oligometastatic Cohort
- Group 2: Dose Escalation Cohort
- Group 3: Large Volume Tumors Cohort
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.
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