Recruiting
Phase 2

Radiotherapy & Checkpoint Inhibition

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06601296

Conditions

Metastatic Renal Cell Carcinoma ( mRCC)

OligoProgressive Metastatic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMSA101

Study Details

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).

Conditions

Metastatic Renal Cell Carcinoma ( mRCC)

OligoProgressive Metastatic Disease

Study ID

NCT06601296

Start date

Apr 1, 2025

Status verified date

Nov, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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)

Interventions

IMSA101

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)

Primary outcome measure

  • 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. [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA

214 648 1836Sarah.Hardee@UTSouthwestern.edu

RAQUIBUL HANNAN, MD, PhD.

214 645 7696Raquibul.Hannan@UTSouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

BUSAYO ADEFALUJO, CLINICAL RESEARCH COORDINATOR

214 648 1873Busayo.Adefalujo@UTSouthwestern.edu

SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA

214 648 1836Sarah.Hardee@UTSouthwestern.edu

Principal Investigator:

RAQUIBUL HANNAN, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • renal
  • kidney
  • mrcc
  • metastatic
  • cancer
  • STING
  • PULSAR
  • SABr
  • SPARK
  • nivolumab
  • IMSA 101

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-11-12.