Actively Recruiting
Study of Iparomlimab and Tuvonralimab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by The Second Affiliated Hospital of Hainan Medical University · Updated on 2026-04-22
32
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of two antibodies, iparomlimab and tuvonralimab, with or without chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have already received at least one systemic therapy. This phase II, open-label study aims to assess the treatment's effectiveness and safety, including objective response rate and other measures like disease control and survival rates. The study also explores how tumor biomarkers relate to treatment response. The study starts with a safety run-in phase with about three patients to check for dose-limiting toxicities. After this, patients receive either antibody monotherapy or the antibody combination plus chemotherapy based on factors such as PD-L1 score, symptoms, disease features, and patient choice. Monotherapy involves the antibodies given intravenously every three weeks. Combination therapy adds up to six cycles of platinum chemotherapy (carboplatin or cisplatin) with either docetaxel or paclitaxel, followed by maintenance antibody treatment. Participants will be monitored regularly for tumor response, survival rates, and side effects throughout the study, which lasts about six months on average. Assessments include imaging to measure tumor changes according to RECIST 1.1 criteria and laboratory tests to monitor safety. Researchers track adverse events and progression-free and overall survival at six months to understand treatment impact and safety.
CONDITIONS
Brief Title
A Study Investigating the Efficacy and Safety of the Combination of Iparomlimab and Tuvonralimab With or Without Chemotherapy in Second-line and Subsequent Treatments for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent prior to any trial procedures
- Age between 18 and 75 years, any gender
- ECOG performance status of 0 to 2
- Pathological confirmation of recurrent or metastatic squamous cell carcinoma of the head and neck, including oropharynx, oral cavity, hypopharynx, or larynx
- Prior systemic therapy for recurrent or metastatic disease
- Expected survival over 3 months
- At least one measurable lesion by RECIST 1.1 criteria
- Resolved acute toxicities from prior therapy to Grade 0-1 or acceptable level
- Normal or controlled thyroid hormone levels
- Adequate organ and bone marrow function within 7 days before grouping
You will not qualify if you...
- History of other cancers unrelated to head and neck squamous cell carcinoma
- Presence of brain or central nervous system metastases
- Active hepatitis B or C infections or unsuitable for immunotherapy
- Life-threatening bleeding episodes within past 3 months
- Recent arterial or venous thromboembolic events within past 6 months
- Recent use of high-dose aspirin or platelet inhibitors
- Symptomatic heart failure or uncontrolled arrhythmias
- Severe bleeding disorders or ongoing thrombolytic therapy
- Recent gastrointestinal perforation, fistula, or severe bowel conditions
- Pulmonary conditions like fibrosis or severe lung impairment
- History of alcohol, psychotropic substance, or drug abuse
- Certain neurological or psychiatric disorders
- Active tuberculosis or recent antituberculosis treatment
- HIV or known syphilis infection
- Active severe infections or poorly controlled infections
- Active autoimmune disease needing systemic treatment within 2 years
- Recent use of immunosuppressive drugs except certain corticosteroids
- Recent live vaccination
- Major surgery within 4 weeks prior to dosing
- Uncontrolled metabolic or systemic diseases increasing medical risk
- Another malignancy within 5 years except some skin cancers
- Severe allergic reactions to study drug components
- Participation in another clinical trial within 4 weeks prior to dosing
- Pregnant or breastfeeding
- Other medical or psychiatric conditions increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Not specified
A safety run-in phase involving approximately 3 to 6 participants to evaluate dose-limiting toxicities before main treatment begins.
Duration - Repeated 21-day cycles until disease progression, unacceptable toxicity, withdrawal, or other discontinuation criteria
Participants receive either combination antibody monotherapy or combination antibody plus chemotherapy based on specific clinical factors and preferences. Monotherapy involves intravenous antibodies every 3 weeks until disease progression or other discontinuation criteria. Combination treatment includes up to 6 cycles of chemotherapy with antibodies followed by antibody monotherapy maintenance.
Every 3 weeks for antibody administration; chemotherapy given on day 1 of each 21-day cycle for up to 6 cycles
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570311
Actively Recruiting
Research Team
Y
yuecan zeng, doctor
J
junnv xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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