Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Radiation Therapy + Checkpoint Inhibitor for Cancer
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 adding a type of radiation therapy to a checkpoint inhibitor drug could help treat some solid cancer types after prior checkpoint inhibitor therapy.
Who is the study for?
Adults with certain solid tumors that have progressed after previous cancer therapy but still have a limited number of metastatic lesions (≤6) may join. They must be in good general health, with proper organ and marrow function, not pregnant or breastfeeding, and willing to use effective contraception. Those with untreated brain metastases, recent anticancer treatments, or specific heart conditions are excluded.Check my eligibility
What is being tested?
This study is testing the combination of PULSAR (a type of targeted radiotherapy) with an immune checkpoint inhibitor plus IMSA101 versus PULSAR with the inhibitor alone in patients whose tumors have started growing again despite treatment. It's a phase 2 trial where participants are randomly assigned to one of these two groups.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiotherapy like skin irritation and fatigue as well as those related to immunotherapy such as flu-like symptoms, possible autoimmune reactions affecting different organs, infusion-related reactions, and increased risk for infections.
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
88 Total Patients Enrolled
Patrick WidhelmStudy DirectorImmuneSensor Therapeutics
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I still have significant side effects from previous cancer treatments.I understand and agree to the study's terms.I haven't had cancer treatment (except for pembrolizumab or nivolumab) in the last 4 weeks.I agree to use two effective birth control methods during the study.I am not pregnant or breastfeeding.My primary cancer needs treatment in addition to the immune therapy.My kidney function is good, with creatinine levels low and clearance high.The study sponsor may decide I can't join based on my medical history or recent health checks.I have previously received STING agonist treatment.I have brain metastases that are either untreated or not stable for at least 4 weeks.I have a tumor that can be injected and is between 10mm and 50mm in size.I am fully active and can carry on all pre-disease activities without restriction.My organs and bone marrow are functioning well.I am 18 years old or older.My cancer has worsened after treatment but had 2 months of stability and has ≤ 6 spread sites.All my cancer spread areas can be treated with radiation.I have had a severe reaction to immune therapy before.All my progressing cancer spots intended for PULSAR treatment have received radiotherapy.My cancer has a mutation that can be treated with standard drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Experimental 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.
How many participants are engaging in this experiment?
"Absolutely. Data hosted on clinicaltrials.gov verifies that this medical study, which was first published on July 7th 2023, is actively recruiting patients to its ranks. In total, 51 participants are sought from a single site of investigation."
Answered by AI
What safety protocols are in place for individuals partaking in the Experimental Arm?
"With the limited evidence currently available, Experimental Arm has been given a safety score of 2. This is due to its standing as a Phase 2 trial where there are preliminary indications of safety but no data backing its efficacy."
Answered by AI
Is enrollment currently available for this investigation?
"Affirmative. The information contained on clinicaltrials.gov highlights that this medical investigation is actively enrolling participants, with the initial posting of the trial taking place on July 7th 2023 and last edited August 15th 2023. Participation requires 51 individuals from a single site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger