Open Menu
Meetings & Education
Meetings & Education
Research & Data
Practice & Patients
Career Development
News & Initiatives
Get Involved
STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients with advanced clear cell renal cell carcinoma (ccRCC).
Background: CAIX is a cell surface glycoprotein expressed in >Â 95% of ccRCC but rarely in normal tissues. Radiolabeling girentuximab, a CAIX-targeting monoclonal antibody, with 177Lu has shown promise as a therapeutic agent in ccRCC. Targeted delivery of radiation to ccRCC cells may prime the immune response, providing rationale for combining 177Lu-girentuximab with nivolumab. This phase 2, open-label, single arm study will evaluate 177Lu-girentuximab in combination with nivolumab in patients with previously treated ccRCC.
Methods:
Eligible patients have locally advanced unresectable or metastatic ccRCC, ≥1 prior line of therapy (including ≥1 anti-PD-1 or anti-PD-L1 antibody), adequate organ function, and ≥1 evaluable lesion as defined by RECIST 1.1 on 89Zr-girentuximab PET/CT. Patients will receive 177Lu-girentuximab (max 3 cycles; IV on day 1 of cycles 1, 4, and 7) and nivolumab (240mg IV q2 weeks starting cycle 1 day 15) until disease progression or unacceptable toxicity. FDG-PET and CT CAP will be performed prior to cycles 1, 4, and 7, and then q12 weeks. All cycles are 28 days. Patients will be evaluated in a 24-week safety lead-in phase followed by an expansion phase.
In the safety lead-in phase, the primary endpoint of maximum tolerated dose (MTD) of 177Lu-girentuximab in combination with nivolumab will be determined with a 3+3 design using a starting dose of 1804 MBq/m2 (75% of single agent MTD). Based on dose limiting toxicities (DLTs), the starting 177Lu-girentuximab dose will be either escalated to 2405 MBq/m2 (cohort 2; single agent MTD) or de-escalated to 1353 MBq/m2 (cohort -1) for the next cohort. Due to expected cumulative myelosuppression, each subsequent 177Lu-girentuximab dose given to the same patient will be reduced by 25% (dose 2 = 75% of dose 1; dose 3 = 75% of dose 2).
In the expansion phase, a Simon 2-stage optimal design will be used to evaluate the primary endpoint of best objective response rate by RECIST 1.1 within 24 weeks. With ≥1 response in the first Simon stage of 10 patients (includes patients treated at MTD during safety lead-in), a second stage will open (n = 19) for a total of 29 patients. The regimen will be considered worthy of further study if there are ≥4 responses in the 29 patients. Secondary endpoints include PFS, OS, and safety. Exploratory imaging with 89Zr-girentuximab PET/CT will be performed at baseline and before each 177Lu-girentuximab dose with results correlated with RECIST response on conventional imaging. In addition, whole body planar and SPECT imaging will be performed after each 177Lu-girentuximab dose to evaluate distribution, lesion uptake, and dosimetry.
The prespecified number of DLTs was exceeded in cohort 2 such that dosing reverted back to 1804 MBq/m2, in which accrual is ongoing.
Disclaimer
This material on this page is ©2025 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Author Details
Darren Feldman
Memorial Sloan Kettering Cancer Center, New York, NY
Authors chevron_right
Associated Organizations chevron_right
Abstract Details
Meeting
2025 ASCO Annual Meeting
Session Type
Poster Session
Session Title
Genitourinary Cancer—Kidney and Bladder
Track
Genitourinary Cancer—Kidney and Bladder
View MoreAbstract Disclosure
open_in_new
Your Privacy
ASCO is committed to transparency regarding our websites and the ways we process data. When you visit our site, we may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences, your location, or your device and is mostly used to make the site work as you expect it to and to personalize your web experience with us.
Because we respect your right to privacy, you can choose not to allow some or all types of cookies. Click on the different category headings to find out more about the types of cookies used on our websites and change your default settings to match your preferences. Please read these carefully. Blocking some types of cookies may impact your experience on the site, including our ability to personalize the content you receive from us.
For a full explanation of the personal and non-personal information we collect on our site, including how we use that information and your rights regarding that information, please review our Privacy Policy. Use of our website is also subject to our Terms of Use.
Allow All
Manage Consent Preferences
Essential Website Cookies
Always Active
These cookies are necessary for the website to function and are sometimes referred to as “strictly necessary” cookies. They make sure the website delivers you information and services in an optimal way.
They are often set in response to an action you take, such as changing your cookie preferences, setting your privacy preferences, logging in to our website, asking the site to remember you on subsequent pages, or filling in forms. These cookies do not identify you personally.
You can set your browser to block or alert you about all cookies, including essential website cookies, but some parts of the site will not work as a result.
Cookies Details‎
Performance and Functionality Cookies
Performance and Functionality Cookies
These cookies enhance the performance and functionality of our websites and the services we provide. For example, these cookies can keep track of your visitor session in between visits, enable you to share content through social media, use embedded media players, and use comment features. They also help us balance website load and improve site speed and performance.
All information these cookies collect is aggregated and therefore anonymous. These cookies may be set by us or by third party providers whose services we have added to our websites. These cookies are non-essential, but without these cookies, certain functionality or enhanced features may become unavailable.
Cookies Details‎
Personalization and Analytics Cookies
Personalization and Analytics Cookies
These cookies collect information that is used to help us understand how our websites and content are used, help us customize our websites and application for you in order to enhance your experience, and help us improve the content that ASCO creates to better meet our members’ and visitors’ needs. Examples include cookies that show us which content might be most popular with our visitors, understand browsing history of our users, understand the effectiveness of our own advertising, and enable us to recommend content to individual users based on their profile and activities on the website.
These cookies may be set by us or by third party providers whose services we have added to our websites.
These cookies are non-essential to the functionality of the site and may contain information that enables us or our third party providers to identify you and build a profile of your interests. Without these cookies, you will not be able to have a customized or personalized experience within our website.
Cookies Details‎
Advertising Cookies and Social Media Cookies
Advertising Cookies and Social Media Cookies
Advertising (or Targeting) cookies are third party cookies that may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant ads on other sites.
Social Media Cookies are cookies set by a range of social media services that we have added to the site to enable you to share our content with your friends and networks. They are capable of tracking your activities across other sites and building a profile of your interests. This may impact the content and messages you see on other websites you visit.
These cookies and the data collected by the third parties may be combined with data from other users or data about your activity on other sites. While the data collected on our site is aggregate or non-personal, the data may be used by such third parties to link you on other platforms or otherwise identify you.
If you do not allow these cookies, you may experience less targeted advertising.
Cookies Details‎
Back Button
Cookie List
Search Icon
Filter Icon
Clear
checkbox labellabel
ApplyCancel
ConsentLeg.Interest
checkbox labellabel
checkbox labellabel
checkbox labellabel
View Cookies
Name
cookie name
Save Settings
iframeBrand%3B24.0.0.0&uamb=0&uam=&uap=Linux%20x86_64&uapv=6.6.72&uaw=0&fledge=1&data=event%3Dgtag.config)
Download