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Radiation boosts immunotherapy in kidney cancer trial

NCT ID NCT04090710

Disease control Sponsor: Ontario Clinical Oncology Group (OCOG) 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether adding precise, high-dose radiation (SBRT) to standard immunotherapy (ipilimumab and nivolumab) can help people with metastatic kidney cancer live longer without their disease getting worse. About 66 participants with intermediate or poor-risk disease will either get immunotherapy alone or immunotherapy plus radiation to their primary kidney tumor. The study is active but no longer recruiting, and results are expected to show if the combination improves progression-free survival.

What this could mean

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

Active substance
Ipilimumab (Yervoy) and Nivolumab (Opdivo) with or without stereotactic body radiation therapy (SBRT)
What this could lead to
If it works, this could show that adding targeted radiation to immunotherapy helps control metastatic kidney cancer longer than immunotherapy alone.
What could go wrong
This is a mid-stage trial with only 66 participants, so results may not apply to everyone. Adding radiation may increase side effects without improving 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

66 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Biopsy proven renal cell carcinoma of any histology. 2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening. 3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II). 4. Primary kidney lesion amenable to SBRT. 5. Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph. Exclusion Criteria: 1. A maximum primary renal lesion size of 20 cm or greater. 2. Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented). 3. Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma. 4. Previous abdominal radiation precluding SBRT. 5. Kanofsky Performance (KPS) score below 60 (see Appendix III). 6. History of auto-immune disorder precluding treatment with ipilimumab or nivolumab. 7. History of ataxia telangiectasia or other radiation sensitivity disorders. 8. Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted). 9. Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician. 10. Inability to lie flat for at least 30 minutes without moving. 11. Pregnant or lactating women. 12. Geographic inaccessibility for follow-up. 13. Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

renal cell carcinoma

As listed by the trial registrant

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

Metastatic renal cell carcinoma

Contacts and locations

Locations

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G1G3, Canada

  • Juravinski Cancer Centre

    Hamilton, Ontario, Canada

  • London Regional Cancer Centre

    London, Ontario, N2G1G3, Canada

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Sunnybrook Health Sciences Centre- Odette Cancer Centre

    Toronto, Ontario, M4N3M5, Canada

  • The Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H8L6, Canada

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