Oligometastatic DiseasePhase 2NCT05846646
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC
A Phase 2 study testing IMSA101, Immune checkpoint inhibitor and PULSAR in people with Oligometastatic Disease, run by ImmuneSensor Therapeutics Inc. at 9 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease
- What is being tested?
- IMSA101, Immune checkpoint inhibitor and PULSAR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Jun 2023to 16 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test prior to first dose of study treatment
- Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Baylor College of Medicine Medical Center
Houston, Texas, 77030
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
The University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligometastatic NSCLC and RCC
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
Read the detailed description
Patients shall be enrolled in 2 treatment arms as follows:
- 20 patients in the control arm (PULSAR-ICI alone)
- 20 patients in the experimental arm (PULSAR-ICI + IMSA101)
Patients will be stratified by histology (NSCLC and RCC) in the randomized portion.
PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.
The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.
All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.
All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).
All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.
- Conditions
- Oligometastatic Disease
- Being tested
- IMSA101, Immune checkpoint inhibitor, PULSAR
- Keywords
- Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Adult
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMSA101Drug
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.
Immune checkpoint inhibitorDrug
Also called pembrolizumab, nivolumab
1st infusion on Cycle 1 Day 2, and then thereafter as per product label
PULSARRadiation
1st day of Cycles 1, 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | PULSAR-ICI + IMSA101 Receives: Drug: IMSA101; Drug: Immune checkpoint inhibitor; Radiation: PULSAR |
| Control Arm | Active comparator | PULSAR-ICI Receives: Drug: Immune checkpoint inhibitor; Radiation: PULSAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tumor Effects
Progression-free rate at 18 months
Measured: 18 months
Secondary outcomes (5)
Number of Participants With Treatment-related Adverse Events
Occurrence of treatment-related adverse events
Measured: Enrolment through end of study period (1 year, 3 months). AE data captured continually.
Anti-tumor Effects
Progression-free at 8-week intervals from 6 months to 22 months
Measured: 6 to 22 months
Anti-tumor Effects
Time to progression
Measured: upon enrolment through end of study period (2 years)
Anti-tumor Effects
Overall response rate, duration of response, progression-free survival
Measured: upon enrolment through end of study period (2 years)
Quality of Life (QoL)
Patient reported outcome on FACT-G questionnaire
Measured: upon enrolment through end of study period (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start28 Jun 2023
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Why it stopped: Change in ImmuneSensor corporate strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuneSensor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Widhelm, Study director, ImmuneSensor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846646
- Sponsor's protocol ID
- IMSA101-102
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2023
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligometastatic NSCLC and RCC
- ClinicalTrials.gov ID
- NCT05846646
- Acronym / sponsor ID
- IMSA101-102
- Conditions
- Oligometastatic Disease
- Keywords
- Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in ImmuneSensor corporate strategy.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ImmuneSensor Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients shall be enrolled in 2 treatment arms as follows:
- 20 patients in the control arm (PULSAR-ICI alone)
- 20 patients in the experimental arm (PULSAR-ICI + IMSA101)
Patients will be stratified by histology (NSCLC and RCC) in the randomized portion.
PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.
The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.
All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.
All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).
All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: IMSA101, Drug: Immune checkpoint inhibitor, Radiation: PULSARPULSAR-ICI + IMSA101 |
| Control Arm | Active comparator | Drug: Immune checkpoint inhibitor, Radiation: PULSARPULSAR-ICI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMSA101Intra-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 | Experimental Arm |
| Immune checkpoint inhibitorAlso: pembrolizumab, nivolumab1st infusion on Cycle 1 Day 2, and then thereafter as per product label | Drug | Control Arm, Experimental Arm |
| PULSAR1st day of Cycles 1, 2 and 3. | Radiation | Control Arm, Experimental Arm |
Primary outcome
Anti-tumor Effects
Time frame: 18 months
Progression-free rate at 18 months
5 secondary outcomes
Number of Participants With Treatment-related Adverse Events
Time frame: Enrolment through end of study period (1 year, 3 months). AE data captured continually.
Anti-tumor Effects
Time frame: 6 to 22 months
Anti-tumor Effects
Time frame: upon enrolment through end of study period (2 years)
Anti-tumor Effects
Time frame: upon enrolment through end of study period (2 years)
Quality of Life (QoL)
Time frame: upon enrolment through end of study period (2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Widhelm study director
ImmuneSensor Therapeutics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMSA101, Immune checkpoint inhibitor and PULSAR in people with Oligometastatic Disease, run by ImmuneSensor Therapeutics Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tumor Effects (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.