Informations générales (source: ClinicalTrials.gov)
A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Interventional
Phase 1
Bristol-Myers Squibb (Voir sur ClinicalTrials)
janvier 2026
avril 2031
12 août 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 15/06/2026 08:35:04 | Contacter | ||
Critères
Tous
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.
- 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.