NCT06601296

Brief Summary

To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
30mo left

Started Apr 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Apr 2025Oct 2028

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

September 11, 2024

Last Update Submit

November 7, 2025

Conditions

Metastatic Renal Cell Carcinoma ( mRCC)OligoProgressive Metastatic Disease

Keywords

renalkidneymrccmetastaticcancerSTINGPULSARSABrSPARKnivolumabIMSA 101

Outcome Measures

Primary Outcomes (1)

  • To evaluate the PFS rate associated with the therapeutic intervention. PFS is defined as the duration of time from initiation of PULSAR/IMSA101 to disease progression as defined by RECIST1.1 or death.

    Exact binomial test will be used to test if the lower limit of the 95% confidence interval of the probability of postponing systemic therapy \>9 months will be greater than 30%.

    Time from initiation of PULSAR/IMSA101 until death from any cause. Follow-up visits to be done every 12 weeks (+/- 1 week) for study duration until patient has progressed. Afterward, subjects to be contacted every 6 months for survival data up to 5 years

Study Arms (1)

SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1

EXPERIMENTAL

Only one arm will be maintained in this phase II study with all patients undergoing the following treatment: SOC treatment: Nivolumab 480 mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1)

Drug: IMSA101

Interventions

IMSA101DRUG

All enrolled patients to undergo the following treatment: SOC treatment: Nivolumab 480mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1)

SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have metastatic ccRCC.
  • Patients must have oligoprogression defined as progression in ≤5 lesions.
  • All oligoprogression lesions must be suitable for radiation.
  • Patients must have at least one site of disease that can be safely injected with IMSA101.
  • Karnofsky Performance Status (KPS) of at least 50%.
  • Age ≥ 18 years.
  • Patients must have adequate organ and marrow function within 14 days prior to study entry.
  • All IMDC risk categories are allowed.

You may not qualify if:

  • Patients with progressive ultracentral/central chest lesions will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasm MetastasisNeoplasmsBites and Stings

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • RAQUIBUL HANNAN, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA

CONTACT

214 648 1836Sarah.Hardee@UTSouthwestern.edu

RAQUIBUL HANNAN, MD, PhD.

CONTACT

214 645 7696Raquibul.Hannan@UTSouthwestern.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

November 12, 2025

Record last verified: 2025-11

Locations

US(1)