Radiation + Immunotherapy for Metastatic Disease

Recruiting at9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ImmuneSensor Therapeutics Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with NSCLC or RCC

Research Team

Patrick Widhelm

Principal Investigator

ImmuneSensor Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

Patient's disease must be evaluable per RECIST Version 1.1

Electrocardiogram (ECG) without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator

Platelets > 50,000 cells/μL

Exclusion Criteria

Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance with study requirements

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.

Treatment Details

Interventions

• Immune checkpoint inhibitor (Checkpoint Inhibitor)
• IMSA101 (Other)
• PULSAR (Radiation)

Trial Overview 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.

Participant Groups

Group I: Experimental Arm Experimental Treatment 3 Interventions

PULSAR-ICI + IMSA101

Group II: Control Arm Active Control 2 Interventions

PULSAR-ICI

Who Is Running the Clinical Trial?

ImmuneSensor Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

60+