New hope for kidney cancer? early trial launches
NCT ID NCT07195682
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug, BMS-986506, in people with advanced clear cell kidney cancer that has not responded to prior treatments. The main goal is to check the drug's safety and how well the body tolerates it. About 125 participants will take the drug alone to see if it can help control the disease.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 281 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 * Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC. * For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy. * For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other). * Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI). * Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy. * Eastern Cooperative Oncology Group performance status of 0 to 1. Exclusion Criteria * Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form. * Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors. * Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor). * Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody). * Participants who have hypoxia as defined by a pulse oximeter reading \< 92% at rest or requires intermittent or chronic supplemental oxygen. * Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention. * Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Locations
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Arthur J.E. Child Comprehensive Cancer Centre
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States
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Gustave Roussy
RECRUITINGVillejuif, Val-de-Marne, 94800, France
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, Barcelona [Barcelona], 08035, Spain
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Hospital Universitario Reina Sofia
RECRUITINGCórdoba, Andalusia, 14004, Spain
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Local Institution - 0031
NOT_YET_RECRUITINGRoma, 00168, Italy
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Local Institution - 0033
NOT_YET_RECRUITINGVerona, 37134, Italy
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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START San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two drugs shrink kidney tumors and their vein clots before surgery?
- Blood test aims to catch Cancer's return earlier
- Engineered immune cells target CD70 in kidney cancer
- Can a new drug target Hard-to-Treat kidney and ovarian cancers?
- Personalized dosing could tame kidney cancer Drug's side effects
- Can teaching patients about immunotherapy cut severe side effects?