Nivolumab and ipilimumab in combination with radiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck Article Swipe
Jennifer M. Johnson
,
Ioannis Vathiotis
,
Larry A. Harshyne
,
Ayesha Ali
,
Voichita Bar Ad
,
Rita Axelrod
,
Emily Lorber
,
Joseph Curry
,
David M. Cognetti
,
Adam Luginbuhl
,
Madalina Tuluc
,
Scott W. Keith
,
Mỹ G. Mahoney
,
Athanassios Argiris
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1136/jitc-2023-007141
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1136/jitc-2023-007141
Background The combination of nivolumab and ipilimumab has been approved for the treatment of multiple solid tumors. This was a phase I study investigating definitive radioimmunotherapy (RIT) with nivolumab and ipilimumab for the treatment of locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN). Methods Patients with newly diagnosed, stage IVA–IVB SCCHN eligible for cisplatin-based chemotherapy received nivolumab (3 mg/kg every 2 weeks for a total of 17 doses) and ipilimumab (1 mg/kg every 6 weeks for a total of 6 doses) starting 2 weeks prior to radiotherapy. The primary endpoint was safety of definitive RIT. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Exploratory endpoints included the association of baseline programmed death-ligand 1 (PD-L1) expression as well as on-treatment changes in immune bias with treatment outcomes. Results Twenty-four patients were enrolled. With a median follow-up of 36.1 months, grade 3 or higher treatment-related adverse events were reported in 21 individuals (88%); 5 individuals developed in-field soft tissue ulceration during consolidation immunotherapy, resulting in one fatality. The 3-year PFS and OS rates were 74% (95% CI 58% to 94%) and 96% (95% CI 88% to 100%), respectively. PD-L1 combined positive score (CPS) did not correlate with death or disease progression. Decreases in extracellular vesicle PD-L1 within the concurrent RIT phase were associated with prolonged PFS (p=0.006). Also, interval decreases in circulating interleukin (IL)4, IL9, IL12, and IL17a during concurrent RIT were associated with subsequent ulceration. Conclusions Definitive RIT with nivolumab and ipilimumab has sufficient clinical activity to support further development. Early changes in circulating biomarkers appear able to predict treatment outcomes as well as ensuing in-field soft tissue ulceration. Trial registration number NCT03162731 .
Related Topics
Concepts
Medicine
Nivolumab
Ipilimumab
Internal medicine
Oncology
Clinical endpoint
Head and neck squamous-cell carcinoma
Pembrolizumab
Radiation therapy
Adverse effect
Head and neck cancer
Immunotherapy
Cancer
Clinical trial
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/jitc-2023-007141
- https://jitc.bmj.com/content/jitc/11/8/e007141.full.pdf
- OA Status
- gold
- Cited By
- 13
- References
- 35
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4385532349
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4385532349Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/jitc-2023-007141Digital Object Identifier
- Title
-
Nivolumab and ipilimumab in combination with radiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neckWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-08-01Full publication date if available
- Authors
-
Jennifer M. Johnson, Ioannis Vathiotis, Larry A. Harshyne, Ayesha Ali, Voichita Bar Ad, Rita Axelrod, Emily Lorber, Joseph Curry, David M. Cognetti, Adam Luginbuhl, Madalina Tuluc, Scott W. Keith, Mỹ G. Mahoney, Athanassios ArgirisList of authors in order
- Landing page
-
https://doi.org/10.1136/jitc-2023-007141Publisher landing page
- PDF URL
-
https://jitc.bmj.com/content/jitc/11/8/e007141.full.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://jitc.bmj.com/content/jitc/11/8/e007141.full.pdfDirect OA link when available
- Concepts
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Medicine, Nivolumab, Ipilimumab, Internal medicine, Oncology, Clinical endpoint, Head and neck squamous-cell carcinoma, Pembrolizumab, Radiation therapy, Adverse effect, Head and neck cancer, Immunotherapy, Cancer, Clinical trialTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
13Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 8, 2024: 5Per-year citation counts (last 5 years)
- References (count)
-
35Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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