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Recruiting Phase 2 NCT06601296

NCT06601296 Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer

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Clinical Trial Summary
NCT ID NCT06601296
Status Recruiting
Phase Phase 2
Sponsor University of Texas Southwestern Medical Center
Condition Metastatic Renal Cell Carcinoma ( mRCC)
Study Type INTERVENTIONAL
Enrollment 15 participants
Start Date 2025-04-01
Primary Completion 2027-10

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
IMSA101

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 15 participants in total. It began in 2025-04-01 with a primary completion date of 2027-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

Eligibility Criteria

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

Contact & Investigator

Central Contact

SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA

✉ Sarah.Hardee@UTSouthwestern.edu

📞 214 648 1836

Principal Investigator

RAQUIBUL HANNAN, MD

PRINCIPAL INVESTIGATOR

University of Texas Southwestern Medical Center

Frequently Asked Questions

Who can join the NCT06601296 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Renal Cell Carcinoma ( mRCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06601296 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT06601296 currently recruiting?

Yes, NCT06601296 is actively recruiting participants. Contact the research team at Sarah.Hardee@UTSouthwestern.edu for enrollment information.

Where is the NCT06601296 trial being conducted?

This trial is being conducted at Dallas, United States.

Who is sponsoring the NCT06601296 clinical trial?

NCT06601296 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is RAQUIBUL HANNAN, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 15 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology