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Can a drug duo outperform standard care for advanced kidney cancer?

NCT ID NCT03141177

Disease control Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This phase 3 trial is comparing a combination of two drugs—nivolumab (an immunotherapy) and cabozantinib (a targeted therapy)—against the current standard drug sunitinib in people with advanced or metastatic kidney cancer who have not yet received systemic treatment. The main goal is to see if the combination delays cancer progression better than sunitinib. Participants are randomly assigned to receive either the combination or sunitinib, and the study tracks how long they live without the cancer worsening, as well as 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
nivolumab combined with cabozantinib
What this could lead to
If successful, this combination could become a new first-line treatment option for advanced kidney cancer, potentially extending the time before the disease worsens.
What could go wrong
The trial is still in progress, and results may not show a clear benefit over the standard treatment. Combining two drugs can also increase side effects.

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

701 people

The number who actually took part.

Started

Jul 2017

Finished

Apr 2026

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.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC * No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria: * Any active CNS metastases * Any active, known or suspected autoimmune disease * Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization * Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria could apply

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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.

Renal cell carcinoma

Contacts and locations

Locations

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454, United States

  • Local Institution - 0001

    Southport, Queensland, 4215, Australia

  • Local Institution - 0002

    North Ryde, New South Wales, 0, Australia

  • Local Institution - 0004

    Elizabeth Vale, South Australia, 5112, Australia

  • Local Institution - 0005

    Malvern, Victoria, 3144, Australia

  • Local Institution - 0006

    Herston, Queensland, 4006, Australia

  • Local Institution - 0007

    Doubleview, Western Australia, 6018, Australia

  • Local Institution - 0008

    Sydney, New South Wales, 2010, Australia

  • Local Institution - 0009

    Sydney, New South Wales, 2139, Australia

  • Local Institution - 0010

    München, 81675, Germany

  • Local Institution - 0011

    Tübingen, 72076, Germany

  • Local Institution - 0013

    Aachen, 52074, Germany

  • Local Institution - 0014

    Nuremberg, 90419, Germany

  • Local Institution - 0016

    Bonn, 53127, Germany

  • Local Institution - 0017

    New York, New York, 10065, United States

  • Local Institution - 0020

    Moscow, 125284, Russia

  • Local Institution - 0021

    Cluj-Napoca, 400015, Romania

  • Local Institution - 0022

    Craiova, 200542, Romania

  • Local Institution - 0023

    Jena, 07747, Germany

  • Local Institution - 0033

    Olomouc, 779 00, Czechia

  • Local Institution - 0034

    Hradec Králové, 500 05, Czechia

  • Local Institution - 0035

    St Louis, Missouri, 63110, United States

  • Local Institution - 0036

    Chicago, Illinois, 60612, United States

  • Local Institution - 0037

    Boston, Massachusetts, 02215, United States

  • Local Institution - 0040

    Buffalo, New York, 14263, United States

  • Local Institution - 0042

    Zion, Illinois, 60099, United States

  • Local Institution - 0044

    Goodyear, Arizona, 85338, United States

  • Local Institution - 0045

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0046

    CABA, Buenos Aires, C1120AAT, Argentina

  • Local Institution - 0047

    San Miguel de Tucumán, 4000, Argentina

  • Local Institution - 0048

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181, Argentina

  • Local Institution - 0049

    Córdoba, X5004FHP, Argentina

  • Local Institution - 0050

    Córdoba, 5000, Argentina

  • Local Institution - 0051

    Pavia, 27100, Italy

  • Local Institution - 0052

    Milan, 20132, Italy

  • Local Institution - 0053

    Padova, Padova, Italy

  • Local Institution - 0054

    Arezzo, 52100, Italy

  • Local Institution - 0055

    Naples, 80131, Italy

  • Local Institution - 0056

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Local Institution - 0057

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Local Institution - 0058

    Barretos, São Paulo, 14784-400, Brazil

  • Local Institution - 0060

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Local Institution - 0061

    São Paulo, 05651901, Brazil

  • Local Institution - 0062

    Mexico City, Mexico City, 06100, Mexico

  • Local Institution - 0063

    Querétaro City, Querétaro, 76000, Mexico

  • Local Institution - 0064

    Monterrey, Nuevo León, 64460, Mexico

  • Local Institution - 0065

    Monterrey, Nuevo León, 64000, Mexico

  • Local Institution - 0066

    Rio de Janeiro, 20231-050, Brazil

  • Local Institution - 0067

    Portland, Oregon, 97239, United States

  • Local Institution - 0068

    Houston, Texas, 77030, United States

  • Local Institution - 0069

    Ramat Gan, 52621, Israel

  • Local Institution - 0070

    Kfar Saba, 44281, Israel

  • Local Institution - 0071

    Petah Tikva, 49414, Israel

  • Local Institution - 0072

    Haifa, 3109601, Israel

  • Local Institution - 0073

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0074

    São Paulo, 01323-020, Brazil

  • Local Institution - 0075

    Dallas, Texas, 75246, United States

  • Local Institution - 0077

    Daphne, Alabama, 36526, United States

  • Local Institution - 0078

    Sherman, Texas, 75090, United States

  • Local Institution - 0080

    Austin, Texas, 78705, United States

  • Local Institution - 0082

    Athens, 115 28, Greece

  • Local Institution - 0083

    Thessaloniki, 546 45, Greece

  • Local Institution - 0084

    Biała Podlaska, 21-500, Poland

  • Local Institution - 0085

    Gdansk, 80-219, Poland

  • Local Institution - 0086

    Newnan, Georgia, 30265, United States

  • Local Institution - 0087

    Wichita, Kansas, 67214, United States

  • Local Institution - 0088

    San Luis Obispo, California, 93401, United States

  • Local Institution - 0090

    Redondo Beach, California, 90277, United States

  • Local Institution - 0091

    Fort Wayne, Indiana, 46804, United States

  • Local Institution - 0093

    Los Angeles, California, 90404, United States

  • Local Institution - 0094

    Ankara, 06800, Turkey (Türkiye)

  • Local Institution - 0095

    Edirne, 22030, Turkey (Türkiye)

  • Local Institution - 0096

    Antalya, 07070, Turkey (Türkiye)

  • Local Institution - 0097

    Denizli, 20070, Turkey (Türkiye)

  • Local Institution - 0099

    Saint Petersburg, 197758, Russia

  • Local Institution - 0102

    Las Vegas, Nevada, 89169, United States

  • Local Institution - 0103

    Aurora, Colorado, 80045, United States

  • Local Institution - 0105

    Nashville, Tennessee, 37203, United States

  • Local Institution - 0106

    Kansas City, Missouri, 64132, United States

  • Local Institution - 0107

    Ankara, 06018, Turkey (Türkiye)

  • Local Institution - 0108

    Zapopan, Jalisco, 45070, Mexico

  • Local Institution - 0109

    Manchester, M20 4BX, United Kingdom

  • Local Institution - 0111

    London, EC1A 7BE, United Kingdom

  • Local Institution - 0113

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0114

    Viedma, Río Negro Province, 8500, Argentina

  • Local Institution - 0115

    Tlalpan, Mexico City, 14080, Mexico

  • Local Institution - 0116

    Mexico City, Mexico City, 14080, Mexico

  • Local Institution - 0117

    Essen, 45136, Germany

  • Local Institution - 0119

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Local Institution - 0120

    Madrid, 28041, Spain

  • Local Institution - 0121

    Madrid, 28009, Spain

  • Local Institution - 0123

    Valencia, 46014, Spain

  • Local Institution - 0124

    Seville, 41013, Spain

  • Local Institution - 0125

    Barcelona, 08035, Spain

  • Local Institution - 0127

    Athens, Georgia, 30607, United States

  • Local Institution - 0129

    South Brisbane, 4101, Australia

  • Local Institution - 0130

    Bydgoszcz, 85796, Poland

  • Local Institution - 0131

    Norfolk, Virginia, 23502, United States

  • Local Institution - 0132

    Tucson, Arizona, 85724-5024, United States

  • Local Institution - 0133

    Bakersfield, California, 93309, United States

  • Local Institution - 0135

    Allentown, Pennsylvania, 18103, United States

  • Local Institution - 0136

    Mérida, Yucatán, 97125, Mexico

  • Local Institution - 0138

    CABA, 1426, Argentina

  • Local Institution - 0139

    Ankara, 06620, Turkey (Türkiye)

  • Local Institution - 0140

    Truro, TR1 3LJ, United Kingdom

  • Local Institution - 0143

    Monterrey, Nuevo León, 64060, Mexico

  • Local Institution - 0144

    Santander, 39008, Spain

  • Local Institution - 0146

    Istanbul, 34300, Turkey (Türkiye)

  • Local Institution - 0147

    Pavia, 27100, Italy

  • Local Institution - 0148

    Akita, Akita, 010-8543, Japan

  • Local Institution - 0149

    Tokyo, 160-8582, Japan

  • Local Institution - 0150

    Niigata, Niigata, 9518520, Japan

  • Local Institution - 0151

    Bunkyo-ku, Tokyo, 1138603, Japan

  • Local Institution - 0152

    Adachi-ku, Tokyo, 123-8558, Japan

  • Local Institution - 0153

    Tokushima, Tokushima, 7708503, Japan

  • Local Institution - 0154

    Osaka, Osaka-shi, 545-8586, Japan

  • Local Institution - 0155

    Hidaka-shi, Saitama, 3501298, Japan

  • Local Institution - 0156

    Hirosaki, Aomori, 036-8563, Japan

  • Local Institution - 0157

    Sapporo, Hokkaido, 0608648, Japan

  • Local Institution - 0158

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Local Institution - 0159

    Morioka, Iwate, 0208505, Japan

  • Local Institution - 0160

    Osakasayamashi, Osaka, 5898511, Japan

  • Local Institution - 0161

    Fukuoka, 812-8582, Japan

  • Local Institution - 0162

    Nagasaki, 8528501, Japan

  • Local Institution - 0163

    Suita-shi, Osaka, 565-0871, Japan

  • Local Institution - 0164

    Sapporo, Hokkaido, 0608543, Japan

  • Local Institution - 0165

    Yamagata, 9909585, Japan

  • Local Institution - 0166

    Yokohama, Kanagawa, 241-8515, Japan

  • Local Institution - 0167

    Chiba, 260-8717, Japan

  • Local Institution - 0168

    Kobe, Hyōgo, 6500017, Japan

  • Local Institution - 0169

    Okayama, Okayama-ken, 7008558, Japan

  • Local Institution - 0170

    Osaka, Osaka, 5418567, Japan

  • Local Institution - 0171

    Yokohama, Kanagawa, 236-0004, Japan

  • Local Institution - 0172

    Terni, 05100, Italy

  • Local Institution - 0173

    Minato-ku, Tokyo, 105-8470, Japan

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