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Checkpoint Inhibitor

Radiotherapy + Checkpoint Inhibitor for Kidney Cancer (SPARK Trial)

Phase 2

Waitlist Available

Led By RAQUIBUL HANNAN, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have metastatic ccRCC

Patients must have oligoprogression defined as progression in ≤3 lesions

Must not have

Patients with progressive ultracentral/central chest lesions will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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 3 months for survival data,up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to track the advancement of kidney cancer that has spread to other parts of the body from the start of a specific type of radiation therapy combined with a certain injectable treatment.

Who is the study for?

This trial is for individuals with metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements.

What is being tested?

The trial is testing the effectiveness of PULSAR radiotherapy when combined with an injectable treatment called IMSA101 in slowing down or stopping the progression of metastatic kidney cancer.

What are the potential side effects?

Potential side effects are not listed but may include typical reactions to radiotherapy like fatigue and skin changes, as well as immune-related responses due to IMSA101. Contacting the study team will provide more specific information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer has spread to other parts of my body.

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My cancer has spread to 3 or fewer places.

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I am 18 years old or older.

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All my cancer spots can be treated with radiation.

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I have a cancer site that can be safely injected, excluding the lungs.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has not spread to the center of my chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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 3 months for survival data,up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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 3 months for survival data,up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 3 months for survival data,up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1Experimental Treatment1 Intervention

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: five intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C1D8, C1D15, C2D1, C3D1)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMSA101

2019

Completed Phase 2

~40

0 / 7Eligibility criteria met