Head and Neck Squamous Cell CarcinomaPhase 2NCT06444009
A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Ivonescimab combined with TP, Cadonilimab combined with TP and Penpulimab combined with TP in people with Head and Neck Squamous Cell Carcinoma, run by Lei Liu at 1 site in China.
Trial summary
A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Ivonescimab combined with TP, Cadonilimab combined with TP and Penpulimab combined with TP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Dec 2027
- 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
- Males and females； Age：18 to 75 years.
- Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).
- Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior treatment for the cancer.
- Intention to undergo curative treatment.
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- Patients with normal organ function and suitable for immunotherapy combined with chemotherapy and surgery:
- Adequate hematologic function (total white blood cell count ≥ 3.0×10^9/L, absolute lymphocyte count ≥ 0.8×10^9/L, absolute neutrophil count ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 90g/L); Adequate hepatic function (bilirubin level ≤ 2 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN); Adequate renal function (serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula), urine protein <2+ on dipstick or <1g in a 24-hour urine collection); Good cardiac function, i.e., normal or clinically insignificant abnormalities on electrocardiogram (ECG), echocardiogram showing a left ventricular ejection fraction (LVEF) ≥50%; Adequate coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; participants on anticoagulation treatment are eligible if the PT is within the therapeutic range of the anticoagulant;
- Blood pressure well controlled (defined as systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg) with or without antihypertensive medication, and no change in antihypertensive treatment within 1 week before the first dose of study medication.
- Patients with HBV infection capable of having detectable HBV DNA levels (≥10IU/mL or above the limit of quantitation) (manifested as positive for hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (anti-HBc)) must receive antiviral therapy according to clinical practice at the site before randomization to ensure adequate viral suppression. Patients must maintain antiviral therapy during the study and for 6 months after the last dose of study treatment. Patients who are anti-HBc positive but do not have detectable HBV DNA (<10IU/mL or below the limit of quantitation) are not required to receive antiviral therapy unless their HBV DNA levels exceed 10IU/mL or the limit of quantitation during treatment.
- Women of childbearing potential (15-49 years old) must have a negative pregnancy test within 7 days before starting treatment; patients of childbearing potential must agree to use effective contraception to ensure they do not become pregnant during the study period and for 3 months after stopping treatment.
- Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Patients who have received any form of anti-tumor treatment previously.
- Patients with allergic constitution and congenital immune deficiencies.
- Patients who have undergone organ transplantation.
- Patients with a history of severe bleeding tendencies or coagulation dysfunction; those who have had clinically significant bleeding symptoms within 1 month prior to the study treatment, including but not limited to gastrointestinal bleeding, hemoptysis; those who have received prolonged anticoagulation treatment within 10 days prior to the study treatment.
- Patients who have experienced arteriovenous thrombotic events within 6 months before the study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Patients with active autoimmune diseases or inflammatory diseases, or a history thereof, including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (excluding diverticulosis), systemic lupus erythematosus, sarcoidosis or Wegener's granulomatosis (e.g., granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis). Exceptions to this criterion include patients with vitiligo or alopecia; patients with stable hypothyroidism after hormone replacement therapy (e.g., following Hashimoto's thyroiditis); patients with any chronic skin disease not requiring systemic treatment; inclusion of patients without active disease in the last 5 years is allowed only after consultation with the study physician.
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- Patients with active infections, including tuberculosis or human immunodeficiency virus (HIV 1/2 antibody positive).
- Patients with uncontrollable complications, including but not limited to: persistent or active infections receiving study treatment (except HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or any psychiatric/social situations that might limit compliance with study requirements, significantly increase the risk of adverse events (AE), or impair the ability of the patient to give written informed consent.
- Pregnant or breastfeeding women.
- Patients who do not agree to use effective contraception during the treatment period and for 3 months thereafter.
- Patients participating in other clinical studies simultaneously.
- Patients who are critically ill and unable to complete the investigation.
- Patients with a history of other primary malignant tumors, except for the following: Malignant tumors treated with curative intent and no known active disease for ≥5 years prior to study treatment and with a low risk of relapse; adequately treated non-melanoma skin cancer or in-situ melanoma without evidence of disease; adequately treated carcinoma in situ without evidence of disease.
- Patients with a history of psychiatric illness (e.g., schizophrenia, mania, anxiety disorder, depression, phobia) or diagnosed with a psychiatric disease at the time of enrollment or their spouses.
- Patients or their spouses with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent normal responses.
- Patients with other malignant neoplastic diseases.
- Patients whom the researcher considers unsuitable for inclusion or whose participation might affect their ability to participate or complete the study for other reasons.
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
West China Hospital
Chengdu, Sichuan
Lei Liu, M.D., +86-028-85422114, liuleihx@gmail.com
About this study
Official title: Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer：A Randomized, Phase II Study
A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection.
This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.
Read the detailed description
In this study, eligible patients will be randomized in a 1:1:1 ratio to either the ivonescimab combined with chemotherapy treatment group (Cohort 1), or the cadonilimab combined with chemotherapy treatment group (Cohort 2), or the penpulimab combined with chemotherapy treatment group (Cohort 3). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Ivonescimab combined with TP, Cadonilimab combined with TP, Penpulimab combined with TP
- Keywords
- Locally advanced head and neck squamous cell carcinoma, Neoadjuvant therapy, Immunotherapy, AK112
- Medical subject headings
- 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.
Ivonescimab combined with TPDrug
Also called ITP
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
Cadonilimab combined with TPDrug
Also called CTP
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
Penpulimab combined with TPDrug
Also called PTP
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab in combination with Nab-paclitaxel + Cisplatin | Experimental | Neoadjuvant:
Patients receive ivonescimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
pCR: Patients receive adjuvant ivonescimab for 16 cycles.
no pCR:
Low/ Medium Risk:
Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles
High Risk:
All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles. Receives: Drug: Ivonescimab combined with TP |
| Cadonilimab in combination with Nab-paclitaxel + Cisplatin | Experimental | Neoadjuvant:
Patients receive cadonilimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
pCR: Patients receive adjuvant cadonilimab for 16 cycles.
no pCR:
Low/ Medium Risk:
Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles
High Risk:
All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles. Receives: Drug: Cadonilimab combined with TP |
| Penpulimab in combination with Nab-paclitaxel + Cisplatin | Experimental | Neoadjuvant:
Patients receive penpulimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
pCR: Patients receive adjuvant penpulimab for 16 cycles.
no pCR:
Low/ Medium Risk:
Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles
High Risk:
All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles. Receives: Drug: Penpulimab combined with TP |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological complete response rate
Measured: After surgery (approximately 9-10 weeks after start of study treatment)
Secondary outcomes (1)
MPR
major pathological remission
Measured: After surgery (approximately 9-10 weeks after start of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2027 (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 Squamous Cell CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Controlled, Phase II Study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444009
- Sponsor's protocol ID
- AK112-IIT-C-W-0001
- Status last verified
- Nov 2024
- First submitted
- 30 May 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer：A Randomized, Phase II Study
- ClinicalTrials.gov ID
- NCT06444009
- Acronym / sponsor ID
- AK112-IIT-C-W-0001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Locally advanced head and neck squamous cell carcinoma, Neoadjuvant therapy, Immunotherapy, AK112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Lei LiuUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (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.
A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection.
This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.
Detailed description
In this study, eligible patients will be randomized in a 1:1:1 ratio to either the ivonescimab combined with chemotherapy treatment group (Cohort 1), or the cadonilimab combined with chemotherapy treatment group (Cohort 2), or the penpulimab combined with chemotherapy treatment group (Cohort 3). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Randomized, Controlled, Phase II Study
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab in combination with Nab-paclitaxel + Cisplatin | Experimental | Drug: Ivonescimab combined with TPNeoadjuvant: Patients receive ivonescimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: pCR: Patients receive adjuvant ivonescimab for 16 cycles. no pCR: Low/ Medium Risk: Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles High Risk: All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles. |
| Cadonilimab in combination with Nab-paclitaxel + Cisplatin | Experimental | Drug: Cadonilimab combined with TPNeoadjuvant: Patients receive cadonilimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: pCR: Patients receive adjuvant cadonilimab for 16 cycles. no pCR: Low/ Medium Risk: Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles High Risk: All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles. |
| Penpulimab in combination with Nab-paclitaxel + Cisplatin | Experimental | Drug: Penpulimab combined with TPNeoadjuvant: Patients receive penpulimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: pCR: Patients receive adjuvant penpulimab for 16 cycles. no pCR: Low/ Medium Risk: Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles High Risk: All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females； Age：18 to 75 years.
- Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).
- Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior treatment for the cancer.
Key exclusion criteria (17 listed)
- Patients who have received any form of anti-tumor treatment previously.
- Patients with allergic constitution and congenital immune deficiencies.
- Patients who have undergone organ transplantation.
- Patients with a history of severe bleeding tendencies or coagulation dysfunction; those who have had clinically significant bleeding symptoms within 1 month prior to the study treatment, including but not limited to gastrointestinal bleeding, hemoptysis; those who have received prolonged anticoagulation treatment within 10 days prior to the study treatment.
- Patients who have experienced arteriovenous thrombotic events within 6 months before the study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
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 |
|---|---|---|
| Ivonescimab combined with TPAlso: ITPBoth interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles. | Drug | Ivonescimab in combination with Nab-paclitaxel + Cisplatin |
| Cadonilimab combined with TPAlso: CTPBoth interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles. | Drug | Cadonilimab in combination with Nab-paclitaxel + Cisplatin |
| Penpulimab combined with TPAlso: PTPBoth interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles. | Drug | Penpulimab in combination with Nab-paclitaxel + Cisplatin |
Primary outcome
pCR
Time frame: After surgery (approximately 9-10 weeks after start of study treatment)
Pathological complete response rate
1 secondary outcome
MPR
Time frame: After surgery (approximately 9-10 weeks after start of study treatment)
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 2 Dec 2024.
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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 Ivonescimab combined with TP, Cadonilimab combined with TP and Penpulimab combined with TP in people with Head and Neck Squamous Cell Carcinoma, run by Lei Liu 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 12 inclusion and 17 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 2 Dec 2024. 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 Lei Liu, M.D. (Liu, liuleihx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: After surgery (approximately 9-10 weeks after start of study treatment)). 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 2 Dec 2024.