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Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC

NCT05846646 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-10-20

Study results available
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Summary

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

Conditions

  • Oligometastatic Disease

Interventions

DRUG

IMSA101

Intra-tumoral administration once weekly for the first three weeks of Cycle 1 (Days 1, 8 and 15) and then on Day 1 of Cycles 2 and 3.

DRUG

Immune checkpoint inhibitor

1st infusion on Cycle 1 Day 2, and then thereafter as per product label

RADIATION

PULSAR

1st day of Cycles 1, 2 and 3.

Sponsors & Collaborators

  • ImmuneSensor Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Widhelm · ImmuneSensor Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2024-09-16
Completion
2024-09-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846646 on ClinicalTrials.gov