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

NCT05846646 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IMSA101-102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Non-small cell lung cancer (NSCLC); Renal cell carcinoma (RCC); Adult

Outcome Measures

Primary Outcomes (1)

• Anti-tumor Effects

  Progression-free rate at 18 months

  18 months

Secondary Outcomes (5)

• Number of Participants With Treatment-related Adverse Events

  Enrolment through end of study period (1 year, 3 months). AE data captured continually.

• Anti-tumor Effects

  6 to 22 months

• Anti-tumor Effects

  upon enrolment through end of study period (2 years)

• Anti-tumor Effects

  upon enrolment through end of study period (2 years)

• Quality of Life (QoL)

  upon enrolment through end of study period (2 years)

Study Arms (2)

Experimental Arm

EXPERIMENTAL

PULSAR-ICI + IMSA101

Drug: IMSA101; Drug: Immune checkpoint inhibitor; Radiation: PULSAR

Control Arm

ACTIVE COMPARATOR

PULSAR-ICI

Drug: Immune checkpoint inhibitor; Radiation: PULSAR

Interventions

IMSA101 DRUG

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.

Experimental Arm

Immune checkpoint inhibitor DRUG

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

Also known as: pembrolizumab, nivolumab

Control Arm; Experimental Arm

PULSAR RADIATION

1st day of Cycles 1, 2 and 3.

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age
• Signed informed consent and mental capability to understand the informed consent
• Histologically or cytologically documented NSCLC or RCC with radiographically documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of "oligometastatic" disease
• Patient's disease must be evaluable per RECIST Version 1.1
• All metastatic lesions amenable to administration of radiotherapy, at the discretion of the investigator
• Must have at least one single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Electrocardiogram (ECG) without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator
• Acceptable organ and marrow function as defined below:
• Absolute neutrophil count (ANC) \> 1,500 cells/μL
• Platelets \> 50,000 cells/μL
• Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN. If liver metastases are present, AST/ALT \< 5 × ULN
• Serum creatinine \< 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
• Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN

You may not qualify if:

• Prior disease progression through programmed cell death ligand 1 (PD-L1 or PD-1)-targeted immunotherapy
• Prior receipt of stimulator of interferon genes (STING) agonist
• Prior receipt of therapeutic radiotherapy to the lesions intended for PULSAR treatment
• Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or \< 5 half-lives of the first dose of study treatment
• Existence of primary tumor that requires therapeutic treatment beyond the provided immune checkpoint inhibitor drug
• Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior anti-cancer therapy, as judged by the investigator
• Previous life-threatening (Grade 4) immune-related adverse event (irAE)
• Existence of actionable mutations that may be eligible for mutation-targeted drug that represents standard-of-care therapy
• Presence of brain metastases
• Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval \> 470)
• Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in the opinion of the investigator would limit compliance with study requirements
• Women who are pregnant or breastfeeding
• Sponsor reserves the right to exclude any patient from the study on the basis of pre-study medical histories, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria

Sponsors & Collaborators

• ImmuneSensor Therapeutics Inc.: lead

Study Sites (9)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Interventions

Immune Checkpoint Inhibitors; pembrolizumab; Nivolumab; DEAE-Dextran

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dextrans; Glucans; Polysaccharides; Carbohydrates

Limitations and Caveats

Study terminated early due to change in ImmuneSensor strategic direction.

Results Point of Contact

• Title: Patrick Widhelm, Senior Director Clinical Operations and Project Management
• Organization: ImmuneSensor Therapeutics, Inc.

pwidhelm@immunesensor.com

830-730-8176

Study Officials

• Patrick Widhelm

  ImmuneSensor Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: June 28, 2023
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)