Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Radiation + Immunotherapy for Metastatic Disease
Phase 2
Recruiting
Research Sponsored by ImmuneSensor Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon enrolment through end of study period (2 years)
Awards & highlights
Study Summary
This trial studies if a combo of radiation & immunotherapy is safe & effective for patients with lung or kidney cancer.
Who is the study for?
This trial is for adults with a limited number of metastatic lung (NSCLC) or kidney cancer (RCC) lesions that can be treated with radiotherapy. Participants must have stable vital signs, normal blood counts and organ function, and agree to use two effective contraception methods if they can have children. People who've had certain prior treatments, brain metastases, significant heart issues, uncontrolled illnesses, or are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The study compares the effects of PULSAR-ICI combined with IMSA101 versus PULSAR-ICI alone in treating oligometastatic NSCLC and RCC. It's a phase 2 trial where patients are randomly assigned to either treatment group to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation in various organs like lungs or intestines; radiotherapy might cause localized skin irritation or damage to nearby tissues/organs depending on the site treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon enrolment through end of study period (2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon enrolment through end of study period (2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Anti-tumor effects
Quality of life (QoL)
Safety and tolerability
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment3 Interventions
PULSAR-ICI + IMSA101
Group II: Control ArmActive Control2 Interventions
PULSAR-ICI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMSA101
2019
Completed Phase 2
~40
Immune checkpoint inhibitor
2017
Completed Phase 1
~142970
Find a Location
Who is running the clinical trial?
ImmuneSensor Therapeutics Inc.Lead Sponsor
3 Previous Clinical Trials
93 Total Patients Enrolled
Patrick WidhelmStudy DirectorImmuneSensor Therapeutics
1 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any cancer treatments except pembrolizumab or nivolumab in the last 4 weeks.My cancer progressed despite treatment targeting PD-1/PD-L1.My primary cancer needs treatment in addition to the immune therapy.I have had radiotherapy on the areas to be treated with PULSAR.I have had a severe reaction to immune therapy before.I am not pregnant or breastfeeding.All my cancer spread areas can be treated with radiation.My organs and bone marrow are functioning well.My cancer has spread to my brain.I still have significant side effects from previous cancer treatments.I understand and agree to the study's terms.I agree to use two effective birth control methods during the study.I am 18 years old or older.I have previously received STING agonist treatment.My cancer has a mutation that can be treated with standard drugs.My kidney function is good, with creatinine levels below 1.5 mg/dL.The study team may decide I can't join based on my health history or recent tests.My lung or kidney cancer has spread, but only to 6 or fewer places.I am fully active or can carry out light work.I have a tumor that can be injected and is between 10mm and 50mm in size.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
- Group 2: Control Arm
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.
Is the recruitment process for this research still open?
"Upon reviewing clinicaltrials.gov, it appears that this particular medical study is no longer accepting applicants. It was originally posted on June 1st 2023 and the most recent update was done on June 28th 2023. Although there are presently no open slots for this trial at present, 22 other studies are actively recruiting patients."
Answered by AI
Has Experimental Arm attained regulatory approval from the FDA?
"The safety of the experimental arm was scored a 2, as there is limited clinical evidence to support its efficacy. However, data does indicate some level of security."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger