Actively Recruiting
Iparomlimab and Tuvonralimab in HNSCC
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2025-07-31
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Iparomlimab and Tuvonralimab in HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years, any gender
- Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma in the oropharynx, oral cavity, hypopharynx, or larynx
- Disease progression after 2 or more lines of anti-tumor systemic therapy
- ECOG performance status of 0 or 1
- Expected survival period of at least 12 weeks
- At least one measurable lesion by RECIST 1.1 criteria
- Availability of tumor tissue for PD-L1 testing within 2 years or fresh tumor tissue
- For oropharyngeal cancer, p16 status determined by IHC
- Normal major organ function within 2 weeks before treatment including bone marrow, liver, renal, blood glucose, and cardiac function
- Negative pregnancy test for women of childbearing age within 7 days before first drug administration
- Use of effective contraception for males and females with potential for pregnancy during and 12 months after treatment
- Voluntary participation with signed informed consent and ability to comply with follow-up
- Physician believes patient may benefit from treatment
You will not qualify if you...
- Tumors outside the oropharynx, larynx, hypopharynx, or oral cavity
- Previous treatment with anti-CTLA-4 drugs
- Central nervous system metastasis or carcinomatous meningitis
- Hearing loss grade 2 or higher, or neuropathy grade 2 or higher on current anti-tumor treatment
- Participation in other drug/therapy clinical trials within 4 weeks before first study drug administration
- Use of hematopoietic stimulating factors within 1 week before first study drug administration
- Positive HIV or Treponema pallidum antibody test
- Active hepatitis B or C infection with elevated viral markers
- Active lung diseases or history of active pulmonary tuberculosis
- Uncontrolled severe infections, poorly controlled diabetes, serious cardiac diseases, recent thrombotic or cardiovascular events within 6 months
- Large pleural effusion or ascites requiring treatment
- Use of CYP3A4 inhibitors within 1 week before screening
- History of stem cell or organ transplantation
- History of substance abuse or mental disorders affecting participation
- Other severe medical conditions or laboratory abnormalities posing risks or interfering with study
- Poor compliance or unsuitable conditions as judged by researcher
- History of other malignancies within 5 years except certain early-stage cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
G
Guoxin Ren, M.D.
CONTACT
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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