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New treatment option for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Official title Iparomlimab and Tuvonralimab in HNSCC
ClinicalTrials.gov ID: NCT07090317
What this study is testing
What is Iparomlimab and Tuvonralimab?
Iparomlimab and Tuvonralimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent/metastatic head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single center, non-randomized, prospective phase II clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab in patients with with recurrent/metastatic head and neck squamous cell carcinoma failed second-line treatment. The participants would receive cetuximab combined with Iparomlimab and Tuvonralimab until termination criteria are met.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18-75 years, regardless of gender; Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (with...
- Normal function of major organs within 2 weeks before treatment, meeting the following criteria:
- Bone marrow function: Hemoglobin ≥ 100g/L, white blood cell count ≥ 4.0×10\^9/L or neutrophil count ≥ 2.0×10\^9/L, and platelet count ≥ 100×10\^9/L...
- people voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; Patients whom...
You likely can't join if
- Tumors outside the oropharynx, larynx, hypopharynx, or oral cavity; Previous treatment with anti-CTLA-4 drugs; Central nervous system metastasis...
- Patients with active hepatitis B or hepatitis C:
- If HBsAg or HBcAb is positive, additional HBV DNA testing is required (with the test result higher than the upper limit of the normal range); If HCV...
- Having any uncontrollable clinical problems, including but not limited to:
- Persistent or active (severe) infections; Poorly controlled diabetes; Cardiac diseases (New York Heart Association class III/IV congestive heart...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.