Clinical trial NCT04540705: A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread
Official title: A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Cell Carcinoma
Keywords: NKTR-214
nivolumab
bempeg
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Nektar Therapeutics
First posted: 2020-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.


Eligibility criteria: 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

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 (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of adverse events (AEs) by severity (Part 1)
timeFrame: Up to 2.5 years
measure: Incidence of serious adverse events (SAEs) (Part 1)
timeFrame: Up to 2.5 years
measure: Incidence of dose-limiting toxicities (DLTs) (Part 1)
timeFrame: Up to 2.5 years
measure: Incidence of AEs leading to discontinuation (Part 1)
timeFrame: Up to 5 years
measure: Incidence of immune-mediated adverse events (imAEs) (Part 1)
timeFrame: Up to 5 years
measure: Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
timeFrame: Up to 2.5 years
measure: Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
timeFrame: Up to 2.5 years
measure: Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
timeFrame: Up to 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Local Institution - 0005
state: Arkansas
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Saint Louis
country: United States
facility: Local Institution - 0001
state: Missouri
city: New York
country: United States
facility: Local Institution - 0009
state: New York
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 0014
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0007
state: Washington
city: Mar del Plata
country: Argentina
facility: Local Institution - 0025
state: Buenos Aires
city: Río Cuarto
country: Argentina
facility: Local Institution - 0075
state: Córdoba
city: Buenos Aires
country: Argentina
facility: Local Institution - 0026
city: San Juan
country: Argentina
facility: Local Institution - 0024
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0030
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0035
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution - 0028
state: RIO Grande DO SUL
city: Santa Cruz do Sul
country: Brazil
facility: Local Institution - 0036
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0032
state: SAO Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution - 0029
state: SAO Paulo
city: Edmonton
country: Canada
facility: Local Institution - 0056
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0015
state: British Columbia
city: St. Johns
country: Canada
facility: Local Institution - 0022
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Local Institution - 0008
state: Ontario
city: Marseille
country: France
facility: Local Institution - 0079
city: Essen
country: Germany
facility: Local Institution - 0042
city: Hannover
country: Germany
facility: Local Institution - 0045
city: Jena
country: Germany
facility: Local Institution - 0040
city: Munich
country: Germany
facility: Local Institution - 0044
city: Nürnberg
country: Germany
facility: Local Institution - 0041
city: Würzburg
country: Germany
facility: Local Institution - 0046
city: Mexico City
country: Mexico
facility: Local Institution - 0048
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution - 0050
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0049
state: Nuevo LEON
city: Queretaro
country: Mexico
facility: Local Institution - 0055
city: Moscow
country: Russian Federation
facility: Local Institution - 0059
city: Moscow
country: Russian Federation
facility: Local Institution - 0052
city: Moscow
country: Russian Federation
facility: Local Institution - 0087
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0051
city: Omsk
country: Russian Federation
facility: Local Institution - 0085
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 0058
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: