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Could a simple shot replace IV drips for kidney cancer patients?

NCT ID NCT04810078

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a subcutaneous (under-the-skin) injection of the drug nivolumab works as well as the standard intravenous (IV) infusion for people with advanced or metastatic clear cell renal cell carcinoma, a type of kidney cancer. About 681 participants who have already received other treatments will be randomly assigned to receive either the shot or the IV. The goal is to see if the shot provides similar drug levels in the blood and similar cancer control, potentially offering a more convenient and less time-consuming treatment option.

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

681 people

The number who actually took part.

Started

May 2021

Expected to finish

May 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.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features * Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV) * Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization * Received no more than 2 prior systemic treatment regimens * Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization * Karnofsky PS ≥ 70 at screening * Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Untreated, symptomatic central nervous system (CNS) metastases * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization * Active, known, or suspected autoimmune disease * Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count \< 350 cells/μL. Participants with HIV are eligible if: 1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization 2. They continue on ART as clinically indicated while enrolled on study 3. CD4 counts and viral load are monitored per standard of care by a local health care provider 4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally * Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible * Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways * Treatment with any live attenuated vaccine within 30 days of first study treatment Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

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

Clear cell renal cell carcinoma

Contacts and locations

Locations

  • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

    Omsk, 644013, Russia

  • Hertzen Moscow Oncology Research Center

    Moscow, 125284, Russia

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040, Russia

  • LLC Eurocityclinic

    Saint Petersburg, 197022, Russia

  • Local Institution

    Chicago, Illinois, 60611, United States

  • Local Institution

    Nice, 6189, France

  • Local Institution

    Milan, 20133, Italy

  • Local Institution

    Nizghiy Novgorod, 603000, Russia

  • Local Institution - 0001

    Poznan, 60-569, Poland

  • Local Institution - 0002

    Cluj-Napoca, 400132, Romania

  • Local Institution - 0005

    Santiago, Santiago Metropolitan, 0, Chile

  • Local Institution - 0008

    Florence, 50134, Italy

  • Local Institution - 0010

    Prague, 140 59, Czechia

  • Local Institution - 0014

    Padova, 35128, Italy

  • Local Institution - 0016

    Craiova, 200347, Romania

  • Local Institution - 0017

    Tampere, 33521, Finland

  • Local Institution - 0018

    Milan, 20141, Italy

  • Local Institution - 0019

    Istanbul, 34098, Turkey (Türkiye)

  • Local Institution - 0020

    Olomouc, 77900, Czechia

  • Local Institution - 0021

    Krakow, 30-688, Poland

  • Local Institution - 0023

    Warsaw, 02-781, Poland

  • Local Institution - 0024

    Bucharest, 022238, Romania

  • Local Institution - 0025

    Buffalo, New York, 14263, United States

  • Local Institution - 0026

    Ankara, 06230, Turkey (Türkiye)

  • Local Institution - 0027

    Meldola, 47014, Italy

  • Local Institution - 0030

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Local Institution - 0031

    Monterrey, Nuevo León, 64710, Mexico

  • Local Institution - 0032

    Sabadell, 08208, Spain

  • Local Institution - 0033

    Cremona, 26100, Italy

  • Local Institution - 0035

    Istanbul, Bagcilar, 34284, Turkey (Türkiye)

  • Local Institution - 0036

    Hradec Králové, 500 05, Czechia

  • Local Institution - 0037

    Pergamino, Buenos Aires, B2700CPM, Argentina

  • Local Institution - 0038

    Buenos Aires, C1426ANZ, Argentina

  • Local Institution - 0039

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

  • Local Institution - 0040

    Cluj-Napoca, 400641, Romania

  • Local Institution - 0041

    Hamilton, 3204, New Zealand

  • Local Institution - 0048

    Barcelona, 08003, Spain

  • Local Institution - 0049

    Barcelona, 08041, Spain

  • Local Institution - 0050

    Coimbra, 3030-075, Portugal

  • Local Institution - 0051

    Suresnes, 92151, France

  • Local Institution - 0052

    Lisbon, 1500-650, Portugal

  • Local Institution - 0053

    Auckland, 1023, New Zealand

  • Local Institution - 0055

    Biała Podlaska, 21-500, Poland

  • Local Institution - 0056

    San Juan, J5402DIL, Argentina

  • Local Institution - 0057

    Terni, 05100, Italy

  • Local Institution - 0058

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Local Institution - 0059

    Seville, 31013, Spain

  • Local Institution - 0060

    Tallaght, Dublin, 0, Ireland

  • Local Institution - 0062

    Bydgoszcz, 85-796, Poland

  • Local Institution - 0063

    Brno, 656 53, Czechia

  • Local Institution - 0064

    Curitiba, Paraná, 80520-174, Brazil

  • Local Institution - 0065

    Querétaro, 76000, Mexico

  • Local Institution - 0066

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Local Institution - 0067

    Madrid, 28033, Spain

  • Local Institution - 0068

    Villejuif, 94800, France

  • Local Institution - 0070

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Local Institution - 0071

    Barretos, São Paulo, 014784-000, Brazil

  • Local Institution - 0072

    Madrid, 28026, Spain

  • Local Institution - 0074

    Madrid, 28046, Spain

  • Local Institution - 0075

    Madrid, 28050, Spain

  • Local Institution - 0076

    Santiago, Santiago Metropolitan, 7500921, Chile

  • Local Institution - 0077

    Viña del Mar, Valparaiso, 2520598, Chile

  • Local Institution - 0078

    Palmerston North, 4414, New Zealand

  • Local Institution - 0079

    Parana, Córdoba Province, 5000, Argentina

  • Local Institution - 0081

    São Paulo, 01246-000, Brazil

  • Local Institution - 0082

    Parma, 43126, Italy

  • Local Institution - 0083

    Gdansk, 80-214, Poland

  • Local Institution - 0084

    Temuco, Araucania, Chile

  • Local Institution - 0085

    Querétaro, 76090, Mexico

  • Local Institution - 0086

    Santander, 39008, Spain

  • Local Institution - 0088

    West Reading, Pennsylvania, 19611, United States

  • Local Institution - 0089

    Tlalpan, Mexico City, 14080, Mexico

  • Local Institution - 0090

    Rio de Janeiro, 20230-130, Brazil

  • Local Institution - 0091

    Rome, 00152, Italy

  • Local Institution - 0092

    Pavia, 27100, Italy

  • Local Institution - 0095

    Capital Federal, Buenos Aires, C1419AHN, Argentina

  • Local Institution - 0096

    São Paulo, 01327-0001, Brazil

  • Local Institution - 0097

    Ankara, 06590, Turkey (Türkiye)

  • Local Institution - 0098

    Krakow, 31-115, Poland

  • Local Institution - 0099

    Ostrava, 708 52, Czechia

  • Local Institution - 0100

    Roma, 00168, Italy

  • Local Institution - 0101

    Torreón, Coahuila, 27010, Mexico

  • Local Institution - 0102

    Barcelona, 08035, Spain

  • Local Institution - 0103

    Monterrey, Nuevo León, 64460, Mexico

  • Local Institution - 0104

    Santiago, Santiago Metropolitan, 7500653, Chile

  • Local Institution - 0105

    San Luis Potosí City, 78200, Mexico

  • Local Institution - 0106

    Praha 8 Liben, 18081, Czechia

  • Local Institution - 0107

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

  • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

    Chelyabinsk, 454087, Russia

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