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Clear Cell Renal Cell Carcinoma (ccRCC)Phase 1NCT07848295

A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)

A Phase 1 study testing BMS-986527, Nivolumab and Cabozantinib in people with Clear Cell Renal Cell Carcinoma (ccRCC), run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 17 sites in 7 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and tolerability of BMS-986527 in participants with Clear Cell Renal Cell Carcinoma (ccRCC) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma (ccRCC)
What is being tested?
BMS-986527, Nivolumab and Cabozantinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
17 sitesin 7 countries
Study dates
31 Dec 2026to 17 Apr 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic renal cell carcinoma (RCC) with clear cell component.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have measurable disease as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • For Cohorts 1 and 2, participants should have previously received, be refractory to, ineligible for, or intolerant of standard of care (SoC) immunotherapy (IO) and/or tyrosine kinase inhibitors (TKIs). Participants in Cohort 3 should have previously received, be refractory to, ineligible for, or intolerant of SoC IO, but those who have not been previously exposed to SoC TKI agents are permitted.

Who cannot join

  • Participants must not have prior history of malignancies (other than clear cell renal cell carcinoma (ccRCC)) or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years.
  • For Cohort 2 only: has relapsed or is refractory within 12 months of the most recent IO therapy.
  • For Cohort 3 only: use of strong inhibitor and inducers of CYP3A4, and P-glycoprotein (P-gp) substrates within 14 days or 5 half-lives (whichever is longer) of start of TKI.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

17 sites in 7 countries

United States6 sites

  • Local Institution - 0022

    Basking Ridge, New Jersey, 07920

    Site 0022

  • Local Institution - 0017

    Cleveland, Ohio, 44195

    Site 0017

  • Local Institution - 0019

    Houston, Texas, 77030

    Site 0019

  • Local Institution - 0018

    New Haven, Connecticut, 06510

    Site 0018

  • Local Institution - 0024

    New York, New York, 10027

    Site 0024

  • Local Institution - 0026

    Seattle, Washington, 98109-1024

    Site 0026

Other trials in United States

Belgium2 sites

  • Local Institution - 0004

    Ghent, Oost-Vlaanderen, 9000

    Site 0004

  • Local Institution - 0003

    Leuven, 3000

    Site 0003

Other trials in Belgium

France2 sites

  • Local Institution - 0014

    Marseille, 13273

    Site 0014

  • Local Institution - 0007

    Villejuif, Val-de-Marne, 94800

    Site 0007

Other trials in France

Germany2 sites

  • Local Institution - 0005

    Essen, North Rhine-Westphalia, 45122

    Site 0005

  • Local Institution - 0012

    Jena, Thuringia, 07747

    Site 0012

Other trials in Germany

Italy2 sites

  • Local Institution - 0011

    Roma, 00168

    Site 0011

  • Local Institution - 0010

    Rozzano, Milano, 20089

    Site 0010

Other trials in Italy

Spain2 sites

  • Local Institution - 0020

    Madrid, 28040

    Site 0020

  • Local Institution - 0002

    Madrid, 28041

    Site 0002

Other trials in Spain

Netherlands1 site

  • Local Institution - 0008

    Amsterdam, 1066 CX

    Site 0008

Other trials in Netherlands

About this study

Official title: A Phase 1, Multicenter, Open-label, Study of BMS-986527, Healthy Donor Allogeneic CD70-targeted Chimeric Antigen Receptor (CAR) T Cells, as Monotherapy or in Novel Combinations in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)

The purpose of this study is to assess the safety and tolerability of BMS-986527 in participants with Clear Cell Renal Cell Carcinoma (ccRCC)

Being tested
BMS-986527, Nivolumab, Cabozantinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986527Drug

    Specified dose on specified days

  • NivolumabDrug

    Also called Opdivo

    Specified dose on specified days

  • CabozantinibDrug

    Also called CABOMETYX

    Specified dose on specified days

Study groups in NCT07848295
Study groupRoleWhat they receive
Cohort 1: BMS-986527 monotherapyExperimentalNot described
Receives: Drug: BMS-986527
Cohort 2: BMS-986527 with NivolumabExperimentalNot described
Receives: Drug: BMS-986527; Drug: Nivolumab
Cohort 3: BMS-986527 with CabozantinibExperimentalNot described
Receives: Drug: BMS-986527; Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Measured: Up to 2 years

  2. Incidence of serious adverse events (SAEs)

    Measured: Up to 2 years

  3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Measured: Up to 2 years

  4. Incidence of AEs leading to discontinuation

    Measured: Up to 2 years

  5. Number of deaths

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Overall response rate (ORR)

    Measured: Up to 2 years

  2. Complete response rate (CRR)

    Measured: Up to 2 years

  3. Disease control rate (DCR)

    Measured: Up to 2 years

  4. Duration of response (DOR)

    Measured: Up to 2 years

  5. Progression-free survival (PFS)

    Measured: Up to 2 years

  6. Time to response (TTR)per investigator assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever comes first

    Measured: Up to 2 years

  7. Overall survival (OS)

    Measured: Up to 2 years

  8. Maximum observed concentration (Cmax)

    Measured: Up to 2 years

  9. Time of maximum observed concentration (Tmax)

    Measured: Up to 2 years

  10. Area under the concentration-time curve from time zero to day 28 (AUC(0-28))

    Measured: Up to 2 years

  11. The persistence of BMS-986527 in peripheral blood from pre-dose to post-treatment follow-up

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion18 Oct 2030 (estimated)
  4. Study completion17 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07848295
Sponsor's protocol ID
CA259-0001
Other IDs
2025-522761-29, U1111-1324-2107, 2025
Status last verified
Sep 2026
First submitted
22 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986527, Nivolumab and Cabozantinib in people with Clear Cell Renal Cell Carcinoma (ccRCC), run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 17 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Belgium, France, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07848295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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