Head and Neck CancerPhase 2NCT07447570
Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC
A Phase 2 study testing Iparomlimab and Tuvonralimab injection, Hypofractionated Radiotherapy and Chemotherapy in people with Head and Neck Cancer and Radiotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy, Anti-PD-1/CTLA-4 Antibody
- What is being tested?
- Iparomlimab and Tuvonralimab injection, Hypofractionated Radiotherapy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed a written informed consent form and understands and agrees to comply with the study requirements and visit schedule.
- Male or female subjects 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.
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- 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 subjects with baseline ≥2+ proteinuria, a 24-hour urine test must show <1 g of protein (if both tests are done, the 24-hour result will determine eligibility).
- Coagulation: International normalized ratio (INR) ≤1.5; activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Subjects 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 after the last dose of study drug).
Who cannot join
- 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.
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- 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-interventional) 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 prophylaxis for nausea, vomiting, or allergic reactions. Other special circumstances should be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical corticosteroids and physiologic replacement doses of adrenal corticosteroids equivalent to >10 mg/day prednisone are allowed.
- 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 inclusion/exclusion thresholds.
- 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 imaging, symptoms or signs of infection within 4 weeks prior to first dose, or requiring oral or IV antibiotics.
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). However, patients with autoimmune hypothyroidism on stable replacement therapy, type I diabetes on stable insulin therapy, vitiligo, or childhood asthma/allergies resolved in adulthood without intervention are eligible.
- 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.
- Subjects 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 abnormal laboratory values, or family/social conditions that may affect subject safety or data collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital Of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Haiyan Chen, Doctor, 86-86992821, chenhaiyan@zju.edu.cn
About this study
Official title: Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multicenter, Single-arm, Phase II Clinical Study
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. Radiotherapy can further stimulate antitumor immunity.
Iparomlimab and Tuvonralimab, a dual anti-PD-1/CTLA-4 antibody, has shown strong activity across several solid tumors, and early studies suggest synergy with hypofractionated radiotherapy. However, evidence in locally advanced HNSCC is lacking.
The investigators therefore propose a multicenter, single-arm phase II trial to assess the efficacy and safety of combining Iparomlimab and Tuvonralimab injection with chemoradiotherapy in locoregionally advanced HNSCC.
- Being tested
- Iparomlimab and Tuvonralimab injection, Hypofractionated Radiotherapy, Chemotherapy
- Keywords
- Head and neck squamous cell carcinoma, hypofractionated radiotherapy, anti-PD-1/CTLA-4 antibody
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab injectionDrug
Induction therapy include Iparomlimab and Tuvonralimab injection combined with hypofractionated radiotherapy (5 Gy × 3) for two cycles, followed by sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin). After completing chemoradiotherapy, patients receive maintenance Iparomlimab and Tuvonralimab injection for at least six months.
Hypofractionated RadiotherapyRadiation
hypofractionated radiotherapy (5 Gy × 3) for two cycles
ChemotherapyDrug
sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Induction therapy include Iparomlimab and Tuvonralimab injection combined with hypofractionated radiotherapy (5 Gy × 3) for two cycles, followed by sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin). After completing chemoradiotherapy, patients receive maintenance Iparomlimab and Tuvonralimab injection for at least six months. Receives: Drug: Iparomlimab and Tuvonralimab injection; Radiation: Hypofractionated Radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival rate (1-year PFS rate)
The proportion of patients who remain alive without disease progression (including local recurrence, regional recurrence, distant metastasis, or death) one year after the start of treatment.
Measured: 1 year from the date of enrollment
Secondary outcomes (5)
Objective Response Rate (ORR)
Objective Response Rate (ORR) refers to the proportion of patients who achieve a measurable reduction in tumor burden, specifically those who experience a complete response (CR) or partial response (PR) according to standardized criteria (such as RECIST).
Measured: From enrollment to the first documented tumor response assessment
Progression-free survival(PFS)
Progression-free survival is the length of time from the start of treatment (or from randomization/enrollment) until the disease progresses or the patient dies from any cause, whichever occurs first.
Measured: From the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 1 year.
Distant Metastasis-Free Survival (DMFS)
Distant Metastasis-Free Survival (DMFS) is the length of time from the start of treatment (or from diagnosis/enrollment) until the first occurrence of distant metastasis or death from any cause, whichever happens first.
Measured: From the date of enrollment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to 1 year.
Overall Survival(OS)
Overall Survival(OS) is defined as the period from the date of first treatment administration to the date of death due to any cause.
Measured: From the date of enrollment until the date of death due to any cause.
Adverse events.
The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
Measured: From enrollment to the end of treatment at 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447570
- Sponsor's protocol ID
- 2025-0946
- Status last verified
- Oct 2025
- First submitted
- 11 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multicenter, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07447570
- Acronym / sponsor ID
- 2025-0946
- Keywords
- Head and neck squamous cell carcinoma, hypofractionated radiotherapy, anti-PD-1/CTLA-4 antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Radiotherapy can further stimulate antitumor immunity.
Iparomlimab and Tuvonralimab, a dual anti-PD-1/CTLA-4 antibody, has shown strong activity across several solid tumors, and early studies suggest synergy with hypofractionated radiotherapy. However, evidence in locally advanced HNSCC is lacking.
The investigators therefore propose a multicenter, single-arm phase II trial to assess the efficacy and safety of combining Iparomlimab and Tuvonralimab injection with chemoradiotherapy in locoregionally advanced HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Iparomlimab and Tuvonralimab injection, Radiation: Hypofractionated Radiotherapy, Drug: ChemotherapyInduction therapy include Iparomlimab and Tuvonralimab injection combined with hypofractionated radiotherapy (5 Gy × 3) for two cycles, followed by sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin). After completing chemoradiotherapy, patients receive maintenance Iparomlimab and Tuvonralimab injection for at least six months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed a written informed consent form and understands and agrees to comply with the study requirements and visit schedule.
- Male or female subjects 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).
Key exclusion criteria (24 listed)
- 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:
- Prior treatments, including:
- 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 inclusion/exclusion thresholds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab injectionInduction therapy include Iparomlimab and Tuvonralimab injection combined with hypofractionated radiotherapy (5 Gy × 3) for two cycles, followed by sequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin). After completing chemoradiotherapy, patients receive maintenance Iparomlimab and Tuvonralimab injection for at least six months. | Drug | Experimental |
| Hypofractionated Radiotherapyhypofractionated radiotherapy (5 Gy × 3) for two cycles | Radiation | Experimental |
| Chemotherapysequential concurrent chemoradiotherapy (50 Gy/25 fractions with two cycles of cisplatin) | Drug | Experimental |
Primary outcome
1-year progression-free survival rate (1-year PFS rate)
Time frame: 1 year from the date of enrollment
The proportion of patients who remain alive without disease progression (including local recurrence, regional recurrence, distant metastasis, or death) one year after the start of treatment.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: From enrollment to the first documented tumor response assessment
Progression-free survival(PFS)
Time frame: From the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 1 year.
Distant Metastasis-Free Survival (DMFS)
Time frame: From the date of enrollment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to 1 year.
Overall Survival(OS)
Time frame: From the date of enrollment until the date of death due to any cause.
Adverse events.
Time frame: From enrollment to the end of treatment at 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab injection, Hypofractionated Radiotherapy and Chemotherapy in people with Head and Neck Cancer and Radiotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Chen, Doctor (86-86992821, chenhaiyan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival rate (1-year PFS rate) (time frame: 1 year from the date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.