NCT04540705CompletedPhase 1
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
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)
Source: ClinicalTrials.gov · Last updated 28 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 3 Sept 2020
- Start date
- 11 Sept 2020
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Kidney cancer
- NCT number
- NCT04540705
- EudraCT number
- 2018-003200-39
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 11 Sept 2020 to the primary completion date, 18 Jan 2024
- 39 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active, known or suspected autoimmune disease
- Inadequately treated adrenal insufficiency
Other
- Active CNS brain metastases or leptomeningeal metastases
Who the study is looking for
- 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:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0026 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | San Juan | Argentina | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Santa Cruz do Sul | Brazil | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0056 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Local Institution - 0041 Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Local Institution - 0049 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Querétaro | Mexico | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Zapopan | Mexico | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0087 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Local Institution - 0085 Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.