Adding ruxolitinib to pembrolizumab for head and neck cancer with high inflammation
Tests ruxolitinib plus pembrolizumab in adults with head and neck squamous cell carcinoma.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Ruxolitinib in Patients With HNSCC and High NLR Treated With Pembrolizumab - The Phase 2 InflammaSTOP Trial
Key facts
- Where
- Basel, Bellinzona, Biel/Bienne, Sankt Gallen, and Zurich, SwitzerlandSee the 5 sites
- Phase
- Phase 2
Where in Switzerland
- University Hospital BaselBasel, SwitzerlandNo longer taking part
- Ente Ospedaliero CantonaleBellinzona, SwitzerlandNo longer taking part
- Seeland Cancer Center BielBiel/Bienne, SwitzerlandNo longer taking part
- Hoch Health OstschweizSankt Gallen, SwitzerlandNo longer taking part
- Universitätsspital ZürichZurich, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Basel, Switzerland
- Trial code
- NCT07840456
- Record updated
- 20 October 2026
- Original description
The goal of this Phase 2 clinical trial is to learn if adding ruxolitinib to pembrolizumab may improve treatment outcomes in patients with head and neck squamous cell carcinoma (HNSCC) who have increased levels of systemic inflammation before treatment, as measured by the neutrophil-to-lymphocyte ratio (NLR). The investigational drug will be used outside of its approved indication (off-label use) based on its known pharmacologic mechanism and prior clinical experience in patients with myeloproliferative neoplasms and graft-versus-host disease.Read full original descriptionShow less
Safety and Efficacy of Ruxolitinib in Patients With Head and Neck Squamous Cell Carcinoma and High Neutrophil-to-Lymphocyte Ratio Treated With Pembrolizumab - The Phase 2 InflammaSTOP Trial
The goal of this Phase 2 clinical trial is to learn if adding ruxolitinib to pembrolizumab may improve treatment outcomes in patients with head and neck squamous cell carcinoma (HNSCC) who have increased levels of systemic inflammation before treatment, as measured by the neutrophil-to-lymphocyte ratio (NLR). The investigational drug will be used outside of its approved indication (off-label use) based on its known pharmacologic mechanism and prior clinical experience in patients with myeloproliferative neoplasms and graft-versus-host disease.
The main questions it aims to answer are:
Is treatment with ruxolitinib in combination with pembrolizumab safe and well tolerated? Can the addition of ruxolitinib improve treatment outcomes compared with historical data? How does ruxolitinib affect the immune system and inflammation when given together with pembrolizumab? How does the combination treatment affect patients' quality of life?
Participants will:
Receive treatment with pembrolizumab and intermittent ruxolitinib. Undergo blood tests to assess immune responses and inflammation. Attend study visits for safety assessments and treatment monitoring. Complete quality-of-life questionnaires, where applicable.
The results of this study will help researchers better understand how inflammation and the body's immune system affect treatment outcomes in people with head and neck cancer. The findings may also help improve the design of future studies investigating new treatment combinations for this disease.
Inclusion: Histologically confirmed diagnosis of R/M HNSCC without local treatment options planned for treatment with pembrolizumab monotherapy (R/M cohort) or locally advanced HNSCC planned for perioperative treatment with pembrolizumab (neoadjuvant cohort); PD-L1 CPS≥1; ECOG-performance score 0-2; NLR >4 before start of pembrolizumab treatment; Signed and dated written informed consent.
Exclusion: Participation in another interventional study simultaneously and within the last 30 days prior to inclusion; Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome; Active, known, or suspected autoimmune disease requiring systemic treatment, a concomitant therapy with systemic immune suppression, up to 5 mg/d prednisolone equivalent is allowed; Any other serious or unstable medical condition that, in the Investigator's judgment, would compromise participant safety or interfere with study conduct; an active infection requiring systemic antimicrobial, antiviral, or antifungal therapy within 14 days before enrolment; or known HIV infection, active hepatitis B (HBsAg positive or detectable HBV DNA), or active hepatitis C (detectable HCV RNA); Anticipated inability to observe the minimum treatment-free interval of at least 48 hours between the last ruxolitinib dose and surgery (neoadjuvant cohort); Known allergy or hypersensitivity reaction to ruxolitinib; Any condition that would require postponement of the planned curative surgical resection to accommodate the neoadjuvant ruxolitinib period (neoadjuvant cohort); Thrombocytopenia (platelet count <100,000/microL) or neutropenia (absolute neutrophil count <1000/mcroL); Patients with severely reduced liver function (Child-Pugh Class C); Pregnancy and lactation.