Renal Cell Carcinoma
Conditions
Keywords
Metastatic clear cell renal cell carcinoma, Advanced clear cell renal cell carcinoma, ccRCC, Kidney cancer
Brief summary
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.
Interventions
DRUGBMS-986506
Specified dose on specified days
DRUGPumitamig
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 2 years from first dose of BMS-986506 |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately 2 years from first dose of BMS-986506 |
| Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria | Up to approximately Day 28 |
| Number of Participants With AEs Leading to Discontinuation | Up to approximately 2 years from first dose of BMS-986506 |
| Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 | Up to approximately 2 years from first dose of BMS-986506 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BMS-986506 | Up to approximately Day 85 |
| Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506 | Up to approximately Day 112 |
| Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506 | Up to approximately Day 112 |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 3 years from first dose of BMS-986506 |
| Disease Control Rate (DCR) as Assessed by RECIST v1.1 | Up to approximately 3 years from first dose of BMS-986506 |
| Duration of Response (DOR) as Assessed by RECIST v1.1 | Up to approximately 3 years from first dose of BMS-986506 |
| Time to Response (TTR) as Assessed by RECIST v1.1 | Up to approximately 3 years from first dose of BMS-986506 |
Countries
Canada, France, Italy, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed