| Study name |
PIVOT IO 011 |
| Methods |
Study type: RCT, parallel assignment, phase 1/2 study
Blinding: no, open‐label
Accrual period: September 11, 2020 ‐ January 17, 2026 (estimated study completion date)
Countries: international (5 countries: Brazil, Argentina, USA, Spain, Canada, ), multicentre
Cross‐over study: no
Status: active, not recruiting (as of May 18, 2022) |
| Participants |
Estimated enrolment: N = 250
Inclusion criteria:
histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC no prior systemic therapy, including prior PD‐L1 therapy, for RCC is allowed with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy life expectancy ≥ 12 weeks Karnofsky Performance Status (KPS) of at least 70% measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria males and females must agree to follow specific methods of contraception, if applicable all sexes, older than 18 years
Exclusion criteria:
active CNS brain metastases or leptomeningeal metastases active, known or suspected autoimmune disease inadequately treated adrenal insufficiency history of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non‐CVA/TIA arterial thromboembolic event (e.g., internal jugular vein thrombosis) within 3 months prior to treatment assignment (part 1) and randomisation (part 2)
*Other protocol‐defined inclusion/exclusion criteria apply |
| Interventions |
Experimental arm I: part 1A (part 1): nivolumab + bempegaldesleukin + bxitinib
Experimental arm II: part 1B (part 1): nivolumab + bempegaldesleukin + cabozantinib
Experimental arm III: arm A (part 2): nivolumab + bempegaldesleukin + cabozantinib
Control arm: arm B (part 2): nivolumab + cabozantinib |
| Outcomes |
Primary outcome(s) :
incidence of AEs by severity (part 1) (time frame: up to 5 years) incidence of SAEs (part 1) (time frame: up to 5 years) incidence of AEs leading to discontinuation (part 1) (time frame: up to 5 years) incidence of immune‐mediated adverse events (imAEs) (part 1) (time frame: up to 5 years)
Secondary outcome(s) :
PFS by RECIST 1.1 by Investigator (part 2) (time frame: up to 32 months from start of part 2) OS (part 2) (time frame: up to 60 months incidence of AEs by severity (part 2) (time frame: up to 5 years) incidence of SAEs (part 2) (time frame: up to 5 years) incidence of AEs leading to discontinuation (part 2) (time frame: up to 5 years) incidence of imAEs (part 2) (time frame: up to 5 years)
Relevant to this review but not reported: QoL, TFST, number of patients who discontinued treatment
Other outcomes (not relevant to this review): DLTs, laboratory results, ORR |
| Starting date |
September 11, 2020 |
| Contact information |
Bristol‐Myers Squibb |
| Notes |
Funding sources: Bristol‐Myers Squibb |
