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New immunotherapy cocktail aims to outsmart kidney cancer

NCT ID NCT07000149

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This large global trial is testing whether two experimental drugs—volrustomig (an immunotherapy) and casdatifan (a pill)—work better than the current standard immunotherapy combination for people with advanced clear cell kidney cancer. About 1,100 participants who have not had prior treatment will be randomly assigned to one of the new combinations or the standard therapy. The study will measure how long people live without their cancer worsening and overall survival.

What this could mean

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

Active substance
Volrustomig (an immunotherapy drug) and Casdatifan (a pill that targets cancer cells)
What this could lead to
If successful, this could offer a new first-line treatment option for advanced kidney cancer that may be more effective than current standard therapy.
What could go wrong
This is an early-stage combination test; it may not prove better than existing treatments, and side effects from the new drugs could be significant.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Histologically or cytologically confirmed RCC with clear cell component. * Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting. * Karnofsky Performance Status ≥ 70%. * Provision of acceptable tumor sample. * At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. Exclusion Criteria: * History of leptomeningeal disease or spinal cord compression. * Symptomatic brain metastases. * Medical history of severe chronic obstructive pulmonary disease. * Active or prior documented autoimmune or inflammatory disorders. * Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma kidney cancer renal cell carcinoma type 1 diabetes mellitus 12

As listed by the trial registrant

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

Advanced clear cell renal cell carcinoma

Contacts and locations

Locations

  • Research Site

    Elizabeth Vale, 5112, Australia

  • Research Site

    Busan, 48108, South Korea

  • Research Site

    Seoul, 03722, South Korea

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