Tests BMS-986506 alone or with other drugs in advanced kidney cancer
Tests whether BMS-986506 is safe for adults with advanced clear cell kidney cancer.
Plain-language title generated from the registry record
Registry title: A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Key facts
- Where
- Rome and Verona, ItalySee the 2 sites
- Phase
- Phase 1
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
- Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07195682EU 2025-522543-18-00
- Record updated
- 11 August 2026
- Original description
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.Read full original descriptionShow less
A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.
Inclusion: 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: 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 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; Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen; Other protocol-defined Inclusion/Exclusion criteria apply.