BridgeMD
New treatment option for Head and Neck Cancer
Official title Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC
ClinicalTrials.gov ID: NCT07447570
What this study is testing
What is Iparomlimab and Tuvonralimab injection?
Iparomlimab and Tuvonralimab injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for head and neck cancer.
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
- Head and neck squamous cell carcinoma (HNSCC) is often diagnosed at a locally advanced stage, where cisplatin-based chemoradiotherapy is standard but still results in high recurrence rates. Immunotherapy is promising for HNSCC due to its high mutational burden, and adding PD-1 inhibitors to induction chemotherapy has improved responses without added toxicity.
- Phase 2: a mid-size study of how well it works
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
- Signed a written informed consent form and understands and agrees to comply with the study requirements and visit schedule.
- Male or female people aged ≥18 and ≤75 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Histologically or cytologically confirmed stage III-IVB head and neck squamous cell carcinoma as assessed by the investigator.
- No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1...
You likely can't join if
- History of allergy to any component of anti-PD-1/CTLA-4 antibodies or cisplatin.
- History or presence of another malignancy (except those cured and without recurrence for more than 5 years, including basal cell carcinoma, carcinoma...
- Uncontrolled cardiac symptoms or diseases, including:
- New York Heart Association (NYHA) class II or higher heart failure.
- Unstable angina.
- Myocardial infarction within the past year.
See the full eligibility criteria
Who can join
- Signed a written informed consent form and understands and agrees to comply with the study requirements and visit schedule.
- Male or female people aged ≥18 and ≤75 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Histologically or cytologically confirmed stage III-IVB head and neck squamous cell carcinoma as assessed by the investigator.
- No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors).
- At least one measurable target lesion per RECIST v1.1 criteria.
- Estimated life expectancy ≥12 weeks.
- Adequate bone marrow and organ function (without receiving any cellular products, blood components, colony-stimulating factors, or cytokine therapy within 14 days prior to laboratory testing):
- Hematology: ANC ≥1.5 × 10⁹/L or within normal range; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L.
- Liver function: Total bilirubin ≤1.5 × ULN; for Gilbert's syndrome, TBIL ≤3 × ULN; AST and ALT ≤2.5 × ULN in patients without liver metastasis, or ≤5 × ULN in those with liver metastasis; albumin ≥28 g/L.
- Renal function: Serum creatinine ≤1.5 × ULN, or creatinine clearance (CCR) ≥60 mL/min (calculated via Cockcroft-Gault formula or measured via 24-hour urine collection); urine dipstick protein \<2+. For people with...
- Coagulation: International normalized ratio (INR) ≤1.5; activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- people who are infertile or agree to use at least one highly effective contraceptive method during the study (starting 14 days before screening or first dose, whichever occurs earlier, and continuing until 180 days...
What rules you out
- History of allergy to any component of anti-PD-1/CTLA-4 antibodies or cisplatin.
- History or presence of another malignancy (except those cured and without recurrence for more than 5 years, including basal cell carcinoma, carcinoma in situ of the cervix, and papillary thyroid carcinoma).
- Uncontrolled cardiac symptoms or diseases, including:
- New York Heart Association (NYHA) class II or higher heart failure.
- Unstable angina.
- Myocardial infarction within the past year.
- Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Prior treatments, including:
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- Use of any investigational drug within 4 weeks prior to the first dose of study drug.
- Concurrent participation in another clinical trial, unless it is an observational (non-treatment) study.
- Requirement for systemic corticosteroid therapy (≥10 mg prednisone or equivalent/day) or other immunosuppressive drugs within 2 weeks prior to the first dose of study drug, except for topical or inhaled steroids, or...
- Receipt of an antitumor vaccine or live vaccine within 4 weeks before the first dose of study drug.
- Major surgery or severe trauma within 4 weeks before the first dose of study drug.
- Failure to recover from previous antitumor therapy to ≤Grade 1 per CTCAE criteria (except for alopecia and residual neuropathy related to prior platinum therapy), or laboratory results not meeting the...
- Severe infection (CTCAE \> Grade 2) within 4 weeks before the first dose of study drug, including severe pneumonia, bacteremia, infections requiring hospitalization, evidence of active pulmonary inflammation on baseline...
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). However, patients with autoimmune...
- History of immunodeficiency, including HIV positivity, acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation.
- History of interstitial lung disease (excluding radiation pneumonitis not requiring steroids) or noninfectious pneumonitis.
- Active tuberculosis based on history or CT imaging; active TB within 1 year prior to enrollment; or remote history of TB (\>1 year prior) without appropriate treatment.
- Active hepatitis B (HBV DNA ≥500 IU/mL or ≥2500 copies/mL) or active hepatitis C (anti-HCV positive with HCV RNA above lower limit of detection).
- History of substance abuse, alcohol abuse, or drug dependence.
- Pregnant or breastfeeding women.
- people whom the investigator considers unsuitable due to factors that may lead to early study discontinuation, such as severe comorbidities requiring concurrent treatment (including psychiatric disorders), significantly...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 Hangzhou, Zhejiang, 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.