Head and Neck CancerPhase 2NCT07882888
Iparomlimab and Tuvonralimab With With Cetuximab in Resectable OSCC
A Phase 2 study testing iparomlimab and tuvonralimab combined with cetuximab in people with Head and Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This is a single-center, single-arm phase II clinical study designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with cetuximab in patients with locally advanced resectable oral squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- iparomlimab and tuvonralimab combined with cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2026to 16 Oct 2029
- 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
- - Aged 18-75 years, male or female;
- Histopathologically confirmed primary stage Ⅲ-Ⅳa surgically resectable oral squamous cell carcinoma, with measurable lesions (≥10 mm on spiral CT, meeting RECIST 1.1 criteria);
- ECOG performance status of 0 or 1;
- Expected survival ≥12 weeks;
- At least one measurable lesion per RECIST 1.1. Previously irradiated lesions may serve as measurable lesions provided disease progression has occurred;
- Availability of tumor tissue for PD-L1 testing (paraffin-embedded specimens obtained within 2 years or fresh tumor tissue);
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- Adequate organ function assessed within 14 days prior to the first dose of study drug, defined as:
- Hematology: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹/L, hemoglobin (HB) ≥9 g/dL (no blood transfusion or component transfusion within 14 days before testing);
- Hepatic: serum total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (AST and ALT ≤5 × ULN permitted in the presence of liver metastases);
- Renal: serum creatinine <1.5 × ULN, or creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L;
- Thyroid-stimulating hormone (TSH) ≤1 × ULN. If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) shall be evaluated; subjects with normal FT3 and FT4 may be enrolled;
- Urine protein ≤1+. If urine protein >1+, 24-hour urine protein quantification is required, with total urinary protein ≤1 g;
- Normal cardiac function: normal electrocardiogram (ECG) or ECG abnormalities of no clinical significance; left ventricular ejection fraction (LVEF) >50% on echocardiography.
- Female subjects of reproductive potential must have a negative serum pregnancy test before the first dose of study drug;
- Male or female subjects of reproductive potential must use highly effective contraceptive methods throughout the study (e.g., oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicide), and continue contraception for 90 days after treatment completion;
- Subjects voluntarily participate in the study, sign the informed consent form, demonstrate good compliance, and agree to follow-up.
Who cannot join
- - Presence of distant metastatic lesions or locally unresectable disease (stage Ⅳb or Ⅳc);
- Prior primary nasopharyngeal carcinoma;
- Participation in another investigational drug/therapy clinical trial within 4 weeks before the first study drug dose;
- Major surgery within 4 weeks before the first study drug dose, or unresolved adverse effects from such surgery; receipt of live vaccine or immunotherapy within 4 weeks; radiotherapy within 2 weeks;
- Concurrent receipt of any other anti-tumor therapy;
- Active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo not requiring systemic therapy is allowed; childhood asthma fully resolved with no intervention required in adulthood is allowed; asthma requiring bronchodilator treatment is excluded);
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- Current use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (>10 mg/day prednisone or equivalent), continued within 2 weeks prior to enrollment;
- History of other malignant tumors within the past 5 years, except cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, early prostate cancer, and carcinoma in situ of the cervix;
- Administration of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF) or erythropoietin within 1 week before the first study drug dose;
- Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies or agonist/antagonist agents targeting T-cell receptors (e.g., OX40, CD137);
- Positive human immunodeficiency virus (HIV) antibody or *Treponema pallidum* antibody;
- Active hepatitis B or hepatitis C infection:
- If HBsAg or HBcAb is positive, HBV DNA testing will be performed (enrollment excluded if above ULN);
- If HCV antibody is positive, HCV RNA testing will be performed (enrollment excluded if above ULN);
- Known hypersensitivity to recombinant humanized anti-PD-1 monoclonal antibody or its components;
- Active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or history of active tuberculosis;
- Any uncontrolled clinical conditions, including but not limited to:
- Persistent or active (severe) infection;
- Poorly controlled hypertension (persistent blood pressure >150/90 mmHg);
- Uncontrolled diabetes mellitus;
- Cardiac disease (New York Heart Association grade Ⅲ/Ⅳ congestive heart failure or cardiac block);
- Events occurring within 6 months before first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism;
- Prior stem cell transplantation or solid organ transplantation;
- History of substance abuse that cannot be discontinued, or history of psychiatric disorders;
- Other severe, acute or chronic medical conditions or laboratory abnormalities that, in the investigator's judgment, may increase risks associated with study participation or interfere with interpretation of study results;
- Poor compliance or other conditions deemed by the investigator to render the subject unsuitable for trial participation.
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
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Guoxin Ren, M.D., 13916948812, renguoxincn@sina.com
About this study
Official title: A Prospective, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab With Cetuximab in Patients With Locally Advanced Resectable Oral Squamous Cell Carcinoma
This is a single-center, single-arm phase II clinical study designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with cetuximab in patients with locally advanced resectable oral squamous cell carcinoma.
The treatment regimen for the experimental group is as follows:
Read more
The recommended dose of epalorestivolimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively.
One clinical tumor imaging assessment will be performed preoperatively per RECIST v1.1 (Appendix 4). In addition, clinically required assessments including vital signs, physical examination, complete blood count, urinalysis, liver and renal function tests, serum electrolytes, thyroid function, electrocardiogram, ECOG performance status, and quality-of-life questionnaires will be completed on Day 1 of each treatment cycle (refer to the study flowchart for specific assessments at each visit). Subjects with hepatitis virus carriage will have viral load monitoring every 2 to 4 treatment cycles.
If PD is assessed per RECIST v1.1 but the subject remains clinically stable or the investigator judges that continued treatment may still benefit the subject, reassessment may be performed 4 weeks later using irRECIST. Treatment may be continued if no progressive disease is identified on reassessment.
- Conditions
- Head and Neck Cancer
- Being tested
- iparomlimab and tuvonralimab combined with cetuximab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iparomlimab and tuvonralimab combined with cetuximabDrug
The recommended dose of iparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment arm | Experimental | iparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively. Receives: Drug: iparomlimab and tuvonralimab combined with cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR rate
the percentage of participants viable tumour cells remaining in the tumour bed after neoadjuvant therapy ≤10%, regardless of the presence or absence of viable tumour cells in the lymph nodes
Measured: 12 months
Secondary outcomes (3)
events free survival
participants documented PD per RECIST 1.1 from enrollment in the neoadjuvant stage, or recurrent or death due to any cause, whichever occurred first.
Measured: 12 months
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Measured: 12 months
overall survival
OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start16 Oct 2026 (estimated)
- Primary completion16 Oct 2028 (estimated)
- Study completion16 Oct 2029 (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.
- 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
- Model description
- iparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ren guoxin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882888
- Sponsor's protocol ID
- SH9H-2026-T645-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab With Cetuximab in Patients With Locally Advanced Resectable Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07882888
- Acronym / sponsor ID
- SH9H-2026-T645-1
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 16 Oct 2028 (estimated)
- Study completion
- 16 Oct 2029 (estimated)
- First posted
- 20 Oct 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.
This is a single-center, single-arm phase II clinical study designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with cetuximab in patients with locally advanced resectable oral squamous cell carcinoma.
The treatment regimen for the experimental group is as follows:
The recommended dose of epalorestivolimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively.
One clinical tumor imaging assessment will be performed preoperatively per RECIST v1.1 (Appendix 4). In addition, clinically required assessments including vital signs, physical examination, complete blood count, urinalysis, liver and renal function tests, serum electrolytes, thyroid function, electrocardiogram, ECOG performance status, and quality-of-life questionnaires will be completed on Day 1 of each treatment cycle (refer to the study flowchart for specific assessments at each visit). Subjects with hepatitis virus carriage will have viral load monitoring every 2 to 4 treatment cycles.
If PD is assessed per RECIST v1.1 but the subject remains clinically stable or the investigator judges that continued treatment may still benefit the subject, reassessment may be performed 4 weeks later using irRECIST. Treatment may be continued if no progressive disease is identified on reassessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- iparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment arm | Experimental | Drug: iparomlimab and tuvonralimab combined with cetuximabiparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- - Aged 18-75 years, male or female;
- Histopathologically confirmed primary stage Ⅲ-Ⅳa surgically resectable oral squamous cell carcinoma, with measurable lesions (≥10 mm on spiral CT, meeting RECIST 1.1 criteria);
- ECOG performance status of 0 or 1;
- Expected survival ≥12 weeks;
- At least one measurable lesion per RECIST 1.1. Previously irradiated lesions may serve as measurable lesions provided disease progression has occurred;
Key exclusion criteria (26 listed)
- - Presence of distant metastatic lesions or locally unresectable disease (stage Ⅳb or Ⅳc);
- Prior primary nasopharyngeal carcinoma;
- Participation in another investigational drug/therapy clinical trial within 4 weeks before the first study drug dose;
- Major surgery within 4 weeks before the first study drug dose, or unresolved adverse effects from such surgery; receipt of live vaccine or immunotherapy within 4 weeks; radiotherapy within 2 weeks;
- Concurrent receipt of any other anti-tumor therapy;
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 combined with cetuximabThe recommended dose of iparomlimab and tuvonralimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively. | Drug | Neoadjuvant treatment arm |
Primary outcome
MPR rate
Time frame: 12 months
the percentage of participants viable tumour cells remaining in the tumour bed after neoadjuvant therapy ≤10%, regardless of the presence or absence of viable tumour cells in the lymph nodes
3 secondary outcomes
events free survival
Time frame: 12 months
Number of Participants Experiencing an Adverse Event (AE)
Time frame: 12 months
overall survival
Time frame: 12 months
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 20 Oct 2026.
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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 combined with cetuximab in people with Head and Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 16 inclusion and 26 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 20 Oct 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 Guoxin Ren, M.D. (13916948812, renguoxincn@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR rate (time frame: 12 months). 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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.