NCT07840456Not yet recruitingPhase 2
Safety and Efficacy of Ruxolitinib in Patients With HNSCC and High NLR Treated With Pembrolizumab - The Phase 2 InflammaSTOP Trial
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Head and neck cancer
- NCT number
- NCT07840456
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From Nov 2026 to the primary completion date, Feb 2029
- 10 sites in 2 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
- 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)
Other illness
- 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)
Lab values
- Thrombocytopenia (platelet count \<100,000/microL) or neutropenia (absolute neutrophil count \<1000/mcroL)
Other
- Patients with severely reduced liver function (Child-Pugh Class C)
- Pregnancy and lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Ente Ospedaliero Cantonale Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Seeland Cancer Center Biel Coordinator of this site? Confirm its status | Biel/Bienne | Switzerland | Unknown status |
| Hoch Health Ostschweiz Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Uniklinik Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitätsmedizin Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Katholisches Krankenhaus Hagen Coordinator of this site? Confirm its status | Hagen | Germany | Unknown status |
| Asklepios Klinik St. Georg Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitätslklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.