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Can a blast of radiation make immunotherapy work better against kidney cancer?

NCT ID NCT02306954

Disease control Sponsor: Providence Health & Services Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding stereotactic body radiation therapy (SBRT) to high-dose Interleukin-2 (IL-2) can improve response rates in people with metastatic renal cell carcinoma. All participants receive IL-2, and half also get two doses of SBRT to a few tumor spots before starting IL-2. The study aims to see if the combination shrinks more tumors than IL-2 alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-dose Interleukin-2 (IL-2) with or without stereotactic body radiation therapy (SBRT)
What this could lead to
If adding SBRT boosts the response rate, this could become a new treatment option for metastatic kidney cancer.
What could go wrong
This is a mid-stage trial with only 84 participants, so results may not apply broadly. High-dose IL-2 can cause serious side effects, and the added radiation may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Dec 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological confirmation of predominant conventional (clear cell) renal cancer * Patients must be ≥ 18 years of age * Tumors amenable to SBRT in lungs (central locations preferred), mediastinum, chest wall, bones with a soft tissue component (other than long bones), or liver, liver hilum and associated lymph nodes (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of protocol treatment. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy * Patients must agree to participate in the Prometheus IL-2 patient registry (PROCLAIM registry) * Patients must sign a study-specific consent form Exclusion Criteria: * No metastatic site amenable to SBRT * Patients with brain metastases not candidates for radiosurgery alone * Previous radiation to sites proposed for SBRT * Patients with active systemic, pulmonary, or pericardial infection * Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus * Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG * Clinically significant underlying pulmonary disease as measured by pulmonary function tests * Blood tests within protocol-specified range * Need for chronic steroids

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Conditions

The condition(s) this trial relates to.

kidney cancer renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • Portland Providence Medical Center

    Portland, Oregon, 97213, United States

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