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New combo therapy aims to slow advanced kidney cancer

NCT ID NCT07011719

Disease control Sponsor: Arcus Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This study tests whether adding the experimental drug casdatifan to the standard drug cabozantinib can slow cancer growth better than cabozantinib alone in people with advanced clear cell kidney cancer. About 720 adults whose cancer worsened after prior immunotherapy will receive either the combination or a placebo plus cabozantinib. The main goal is to see how long the cancer stays under control.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 720 people

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

Started

Sep 2025

Expected to finish

Dec 2030

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: * Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component. * A Karnofsky Performance Status (KPS) score ≥ 80% * At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy. * Adequate organ and marrow function, ≤ 1 week prior to randomization. * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. Exclusion Criteria: * Received prior treatment with a HIF-2α inhibitor or cabozantinib. * Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured. * Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies. * Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \> 150 mmHg systolic or \> 90 mmHg diastolic despite optimal antihypertensive treatment. * History of leptomeningeal disease or spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma Clear-cell metastatic renal cell carcinoma kidney cancer

As listed by the trial registrant

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

Advanced clear cell renal cell carcinoma Metastatic clear cell renal cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    176 sites in 16 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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    Gilbert, Arizona, 85234, United States

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    Goodyear, Arizona, 85338, United States

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    Phoenix, Arizona, 85054, United States

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    Duarte, California, 91010, United States

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    Irvine, California, 91304, United States

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    La Jolla, California, 92103, United States

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    Los Angeles, California, 90095, United States

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    Palo Alto, California, 94304, United States

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    Sacramento, California, 95817, United States

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    San Diego, California, 92103, United States

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    Aurora, Colorado, 80045, United States

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    New Haven, Connecticut, 06519, United States

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    Washington D.C., District of Columbia, 20057, United States

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    Jacksonville, Florida, 32224, United States

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    Miami, Florida, 33136, United States

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    Orlando, Florida, 32804, United States

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    Atlanta, Georgia, 30318, United States

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    Atlanta, Georgia, 30322, United States

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    Newnan, Georgia, 30265, United States

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    Zion, Illinois, 60099, United States

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    Indianapolis, Indiana, 46202, United States

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    Louisville, Kentucky, 40207, United States

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    Jefferson, Louisiana, 70121, United States

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    Baltimore, Maryland, 21287, United States

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    Boston, Massachusetts, 02114, United States

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    Boston, Massachusetts, 02215, United States

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    Rochester, Minnesota, 55905, United States

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    St Louis, Missouri, 63110, United States

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    Omaha, Nebraska, 68198, United States

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    New Brunswick, New Jersey, 08903, United States

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    Buffalo, New York, 14263, United States

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    New York, New York, 10461, United States

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    Rochester, New York, 14642, United States

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    Chapel Hill, North Carolina, 27514, United States

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    Durham, North Carolina, 27710, United States

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    Cleveland, Ohio, 44106, United States

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    Portland, Oregon, 97212, United States

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    Monroeville, Pennsylvania, 15146, United States

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    Charleston, South Carolina, 29425, United States

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    Nashville, Tennessee, 37203, United States

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    Nashville, Tennessee, 37232, United States

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    Dallas, Texas, 75390, United States

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    Lubbock, Texas, 79430, United States

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    Salt Lake City, Utah, 84112, United States

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    Charlottesville, Virginia, 22903, United States

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    Seattle, Washington, 98109, United States

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    Buenos Aires, Argentina

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    La Plata, Argentina

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    Viedma, Argentina

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    Box Hill, Australia

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    Chermside, Australia

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    Elizabeth Vale, Australia

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    Frankston, Australia

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    Frenchs Forest, Australia

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    Heidelberg, Australia

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    Hobart, Australia

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    Kurralta Park, Australia

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    Macquarie Park, Australia

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    Saint Leonards, Australia

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    South Brisbane, Australia

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    St Albans, Australia

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    Subiaco, Australia

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    Westmead, Australia

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    Calgary, Canada

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    Edmonton, Canada

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    Hamilton, Canada

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    Montreal, Canada

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    Sherbrooke, Canada

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    Toronto, Canada

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    Vancouver, Canada

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    Brno, Czechia

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    Brno-střed, Czechia

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    České Budějovice, Czechia

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    Hradec, Czechia

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    Prague, Czechia

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    Angers, France

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    Brest, France

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    Caen, France

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    Clermont-Ferrand, France

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    Lille, France

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    Marseille, France

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    Montpellier, France

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    Paris, France

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    Pessac, France

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    Poitiers, France

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    Reims, France

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    Rennes, France

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    Strasbourg, France

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    Toulouse, France

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    Villejuif, France

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    Berlin, Germany

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    Dresden, Germany

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    Essen, Germany

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    Frankfurt, Germany

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    Freiburg im Breisgau, Germany

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    Halle, Germany

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    Hanover, Germany

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    Heidelberg, Germany

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    Leipzig, Germany

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    Lübeck, Germany

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    Marburg, Germany

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    Rostock, Germany

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    Ulm, Germany

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    Milan, Italy

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    Naples, Italy

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    Padua, Italy

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    Rome, Italy

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    Rozzano, Italy

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    Terni, Italy

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    Verona, Italy

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    Akita, Japan

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    Asahikawa, Japan

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    Fukuoka, Japan

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    Hidaka, Japan

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    Hiroshima, Japan

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    Kobe, Japan

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    Matsuyama, Japan

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    Nagoya, Japan

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    Nankoku, Japan

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    Osaka, Japan

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    Sapporo, Japan

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    Shinjuku, Japan

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    Tokyo, Japan

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    Yokohama, Japan

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    Amsterdam, Netherlands

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    Maastricht, Netherlands

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    Nijmegen, Netherlands

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    Rotterdam, Netherlands

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    Utrecht, Netherlands

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    Zwolle, Netherlands

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    Auckland, New Zealand

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    Christchurch, New Zealand

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    Hamilton, New Zealand

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    Rotorua, New Zealand

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    Krakow, Poland

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    Otwock, Poland

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    Poznan, Poland

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    Rzeszów, Poland

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    Skorzewo, Poland

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    Tomaszów Mazowiecki, Poland

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    Warsaw, Poland

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    Wroclaw, Poland

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    Bucharest, Romania

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    Craiova, Romania

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    Iași, Romania

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    Suceava, Romania

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    Timișoara, Romania

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    Busan, South Korea

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    Daejeon, South Korea

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    Goyang, South Korea

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    Seongnam, South Korea

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    Seoul, South Korea

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    Suwon, South Korea

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    Barcelona, Spain

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    Córdoba, Spain

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    Madrid, Spain

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    Majadahonda, Spain

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    Málaga, Spain

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    Pamplona, Spain

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    Santander, Spain

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    Seville, Spain

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    Vigo, Spain

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    Cambridge, United Kingdom

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    Cottingham, United Kingdom

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    Exeter, United Kingdom

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    Glasgow, United Kingdom

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    Leeds, United Kingdom

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    London, United Kingdom

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    Manchester, United Kingdom

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    Newcastle upon Tyne, United Kingdom

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    Northwood, United Kingdom

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    Preston, United Kingdom

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    Southampton, United Kingdom

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    Sutton, United Kingdom

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    Truro, United Kingdom

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    Whitchurch, United Kingdom

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