Head and Neck Squamous Cell CarcinomaPhase 2NCT06814067
Phase II Multi-centered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Pembrolizumab, Ivonescimab and Surgery in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma HNSCC, run by Fudan University at 1 site in China.
Trial summary
Head and neck squamous cell carcinoma (HNSCC) is one of the common malignant tumors in the world. More than 60% of HNSCC patients are locally advanced when first diagnosed. The treatment effect of locally advanced HNSCC is not ideal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- Pembrolizumab, Ivonescimab and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ) Patients who signed the informed consent and were willing to complete the study according to the protocol.
- ) Age ≥18.
- ) Patients diagnosed with head and neck squamous cell carcinoma by histology, including those with primary lesions in the oropharynx, oral cavity, larynx, or hypopharynx, or those with head and neck squamous cell carcinoma of unknown primary lesion after comprehensive examination and multidisciplinary discussion.
- ) Locally advanced head and neck squamous cell carcinoma that can be surgically resected ( AJCC staging 8th edition: stage III-IVB), excluding T4b.
- ) There was at least one measurable lesion before treatment, which met the requirement of " measurable lesion " in RECIST 1.1 standard.
- ) Expected survival period: >3 months.
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- ) ECOG score 0-1.
- ) Good organ function: Meet the following requirements:
- Absolute neutrophil count ( ANC ) ≥ 1.5 ×10 9 / L ;
- Platelet count ≥ 100 × 10 9 / L ;
- Hemoglobin ≥ 9 g/ dL ;
- Serum albumin ≥ 2.8 g/ dL ;
- Total bilirubin ≤ 1.5 × ULN , ALT , AST and / or ALP ≤ 2.5 × ULN ;
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault );
- Activated partial thromboplastin time ( APTT ) and international normalized ratio ( INR ) ≤ 1.5 × ULN (screening is allowed for patients who are using stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and whose INR is within the expected therapeutic range of the anticoagulant ).
- ) Patients with hepatitis B virus ( HBV ) infection and inactive / asymptomatic HBV carriers, or patients with chronic or active HBV , will be allowed to enroll if HBV DNA <500 IU/mL (or 2500 copies/mL ) at screening . Patients with positive hepatitis C antibodies will be allowed to enroll if HCV-RNA is negative at screening .
- ) Women of childbearing age , who must have a negative urine or serum pregnancy test result within 7 days before treatment . They must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills or condoms) during the study treatment, at least 3 months after the last use of immunotherapy and at least 6 months after the last use of chemotherapy.
- ) Male subjects who are not sterilized must be willing to use a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during the study treatment, at least 3 months after the last use of immunotherapy, and at least 6 months after the last use of chemotherapy.
Who cannot join
- Patients who have had or are suffering from other malignant tumors in the past (except for those who have been cured and have survived cancer-free for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma).
- Received any of the following treatments:a. Received any investigational drug within 4 weeks before the first use of the investigational drug; b. Enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study; c. Subjects who need to be given corticosteroids (≥ 10 mg prednisone equivalent per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergies, nausea and vomiting. Other special cases need to be communicated with the investigator. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal cortical hormone replacement with a dose of ≥ 10 mg/ day prednisone efficacy dose are allowed; d. Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug (if the new coronavirus vaccine is received, the interval between the vaccination and treatment must be more than 2 weeks) .
- Uncontrolled cardiac clinical symptoms or diseases, such as: a. NYHA grade II or above heart failure; b. Unstable angina; c. Myocardial infarction within 1 year; d. Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Severe infection ( CTCAE > 2 ) occurred within 4 weeks before the first use of the study drug , such as severe pneumonia, bacteremia, infectious complications requiring hospitalization, etc.; baseline chest imaging examination indicated active lung inflammation, symptoms and signs of infection within 4 weeks of the first use of the study drug, or the need for oral or intravenous antibiotic treatment.
- Patients with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excluding autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes using stable doses of insulin; patients with vitiligo or healed childhood asthma / allergy who do not require any intervention as adults.
- Have a history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.
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- A history of interstitial lung disease (excluding radiation pneumonitis without hormone treatment) or non-infectious pneumonia.
- Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment.
- Subjects have active hepatitis B ( HBV DNA ≥ 500 IU/mL or 2500 copies/mL ), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method).
- Underwent major surgery or severe trauma in the past 30 days.
- The researcher assesses that the patient has a high risk of bleeding (such as a history of severe bleeding tendency or abnormal coagulation function, such as the tumor enveloping the carotid artery >180 degrees, the tumor invading the trachea, etc.).
- Known history of psychotropic substance abuse, alcoholism or drug abuse.
- Pregnant or breastfeeding women.
- The researcher judges that the subject has other factors that may force him/her to terminate the study midway, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors that may affect the safety of the subject or the collection of trial data.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase II Multicentered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinoma (HNSCC) is one of the common malignant tumors in the world. More than 60% of HNSCC patients are locally advanced when first diagnosed. The treatment effect of locally advanced HNSCC is not ideal. About 50-60% of patients will have local recurrence within 2 years, and 20-30% of patients will have distant metastasis. The 5-year disease control rate is approximately 40%, and the 5-year overall survival rate is less than 50%.
In recent years, PD-1 inhibitors have shown significant efficacy in recurrent/metastatic HNSCC. The Keynote 040 and Checkmate 141 studies established the status of PD-1 inhibitors as second-line treatment in recurrent/metastatic HNSCC. The Keynote 048 study further established the value of PD-1 inhibitors alone or in combination with chemotherapy in the first-line treatment of recurrent/metastatic HNSCC. An increasing number of studies have attempted to explore the value of neoadjuvant therapy with PD-1 inhibitors in locally advanced HNSCC. For example,The Checkmate 358 study showed that the clinical objective response rate of neoadjuvant nivolumab monotherapy was 10.2%, and the major pathological response rate (MPR) was 2.9%.
Read more
Ivonescimab is a new PD-1/VEGF bispecific antibody drug, which can block both the PD-1 pathway and the VEGF pathway. This dual blocking mechanism is expected to enhance the efficacy of immunotherapy by improving the tumor microenvironment. Ivonescimab has been studied in Phase II to Phase III clinical studies in multiple tumor types such as lung cancer, breast cancer, and head and neck squamous cell carcinoma. For example, the HARMONi-2 study showed that ivocilizumab monotherapy had significantly better progression-free survival (PFS) than pembrolizumab in the treatment of PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). In recurrent and metastatic HNSCC, Ivonescimab alone or in combination with the CD47 monoclonal antibody Ligufalimab has better objective response rate (ORR) and disease control rate (DCR) than pembrolizumab.
The aim of this study is to compare the efficacy and safety of perioperative treatment with Ivonescimab and pembrolizumab in surgically resectable locally advanced head and neck squamous cell carcinoma.
- Being tested
- Pembrolizumab, Ivonescimab, Surgery, Adjuvant radiotherapy
- Keywords
- Neoadjuvant therapy, Immunotherapy, Ivonescimab, pembrolizumab
- 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.
PembrolizumabDrug
Two cycles of neoadjuvant pembrolizumab (200mg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of pembrolizumab (200mg q3w)maintenance therapy was given.
IvonescimabDrug
Two cycles of neoadjuvant Ivonescimab (10mg/kg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of Ivonescimab maintenance therapy (10mg/kg q3w) was given.
SurgeryProcedure or surgery
Radical surgery
Adjuvant radiotherapyRadiation
Adjuvant radiotherapy with/without concurrent cisplatin-based chemotherapy, based on pathologic risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative pembrolizumab | Active comparator | Neoadjuvant pembrolizumab two cycles, followed by radical surgery. Adjuvant radiation/chemoradiation was decided based on pathologic risk factors. Then maintenance therapy of pembrolizumab for fifteen cycles was given. Receives: Drug: Pembrolizumab; Procedure: Surgery; Radiation: Adjuvant radiotherapy |
| Perioperative Ivonescimab | Experimental | Neoadjuvant ivonescimab two cycles, followed by radical surgery. Adjuvant radiation/chemoradiation was decided based on pathologic risk factors. Then maintenance therapy of ivonescimab for fifteen cycles was given. Receives: Drug: Ivonescimab; Procedure: Surgery; Radiation: Adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response
Major pathologic response, defined as ≤10% residual viable tumor in the resected primary tumor and lymph node tissue
Measured: 4 months
Secondary outcomes (5)
Event-free survival rate
Event free survival, defined as the time from the randomization to the first occurrence of any of the following events-disease progression that precludes surgical treatment, local recurrence or distant metastasis, or death from any cause. The Kaplan Meier method was used to estimate the EFS rate for each treatment group at 1 year after treatment assignment.
Measured: One year
Overall survival rate
Overall survival, defined as the time from randomization to death from any cause. The Kaplan Meier method was used to estimate the OS rate for each treatment group at 1 year after treatment assignment.
Measured: One year
pCR rate
Pathologic complete response rate, defined as no residual tumor within the resected primary disease and lymph node tissue.
Measured: 4 months
Overall response of neoadjuvant therapy
Neoadjuvant treatment objective response rate (ORR), defined as the proportion of CR and PR subjects in each treatment group who took at least one cycle of neoadjuvant treatment, per RECIST 1.1 criteria.
Measured: 8 weeks
Adverse event
AE refers to an adverse medical event that occurs after a clinical trial subject receives a drug, but it is not necessarily causally related to the treatment. AE can be any unfavorable and unexpected symptoms, signs, laboratory abnormalities or diseases.
Measured: From the time of randomization to 90 days after the last dose of immunotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion10 Feb 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814067
- Sponsor's protocol ID
- Insight-4
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wise-Draper TM, Gulati S, Palackdharry S, Hinrichs BH, Worden FP, Old MO, Dunlap NE, Kaczmar JM, Patil Y, Riaz MK, Tang A, Mark J, Zender C, Gillenwater AM, Bell D, Kurtzweil N, Mathews M, Allen CL, Mierzwa ML, Casper K, Jandarov R, Medvedovic M, Lee JJ, Harun N, Takiar V, Gillison M. Phase II Clinical Trial of Neoadjuvant and Adjuvant Pembrolizumab in Resectable Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2022 Apr 1;28(7):1345-1352. doi: 10.1158/1078-0432.CCR-21-3351.
PubMed 35338369Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14.
PubMed 32665297
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicentered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06814067
- Acronym / sponsor ID
- Insight-4
- Keywords
- Neoadjuvant therapy, Immunotherapy, Ivonescimab, pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 10 Feb 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 7 Feb 2025 (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 one of the common malignant tumors in the world. More than 60% of HNSCC patients are locally advanced when first diagnosed. The treatment effect of locally advanced HNSCC is not ideal. About 50-60% of patients will have local recurrence within 2 years, and 20-30% of patients will have distant metastasis. The 5-year disease control rate is approximately 40%, and the 5-year overall survival rate is less than 50%.
In recent years, PD-1 inhibitors have shown significant efficacy in recurrent/metastatic HNSCC. The Keynote 040 and Checkmate 141 studies established the status of PD-1 inhibitors as second-line treatment in recurrent/metastatic HNSCC. The Keynote 048 study further established the value of PD-1 inhibitors alone or in combination with chemotherapy in the first-line treatment of recurrent/metastatic HNSCC. An increasing number of studies have attempted to explore the value of neoadjuvant therapy with PD-1 inhibitors in locally advanced HNSCC. For example,The Checkmate 358 study showed that the clinical objective response rate of neoadjuvant nivolumab monotherapy was 10.2%, and the major pathological response rate (MPR) was 2.9%.
Ivonescimab is a new PD-1/VEGF bispecific antibody drug, which can block both the PD-1 pathway and the VEGF pathway. This dual blocking mechanism is expected to enhance the efficacy of immunotherapy by improving the tumor microenvironment. Ivonescimab has been studied in Phase II to Phase III clinical studies in multiple tumor types such as lung cancer, breast cancer, and head and neck squamous cell carcinoma. For example, the HARMONi-2 study showed that ivocilizumab monotherapy had significantly better progression-free survival (PFS) than pembrolizumab in the treatment of PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). In recurrent and metastatic HNSCC, Ivonescimab alone or in combination with the CD47 monoclonal antibody Ligufalimab has better objective response rate (ORR) and disease control rate (DCR) than pembrolizumab.
The aim of this study is to compare the efficacy and safety of perioperative treatment with Ivonescimab and pembrolizumab in surgically resectable locally advanced head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative pembrolizumab | Active comparator | Drug: Pembrolizumab, Procedure: Surgery, Radiation: Adjuvant radiotherapyNeoadjuvant pembrolizumab two cycles, followed by radical surgery. Adjuvant radiation/chemoradiation was decided based on pathologic risk factors. Then maintenance therapy of pembrolizumab for fifteen cycles was given. |
| Perioperative Ivonescimab | Experimental | Drug: Ivonescimab, Procedure: Surgery, Radiation: Adjuvant radiotherapyNeoadjuvant ivonescimab two cycles, followed by radical surgery. Adjuvant radiation/chemoradiation was decided based on pathologic risk factors. Then maintenance therapy of ivonescimab for fifteen cycles was given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- ) Patients who signed the informed consent and were willing to complete the study according to the protocol.
- ) Age ≥18.
- ) Patients diagnosed with head and neck squamous cell carcinoma by histology, including those with primary lesions in the oropharynx, oral cavity, larynx, or hypopharynx, or those with head and neck squamous cell carcinoma of unknown primary lesion after comprehensive examination and multidisciplinary discussion.
- ) Locally advanced head and neck squamous cell carcinoma that can be surgically resected ( AJCC staging 8th edition: stage III-IVB), excluding T4b.
- ) There was at least one measurable lesion before treatment, which met the requirement of " measurable lesion " in RECIST 1.1 standard.
Key exclusion criteria (14 listed)
- Patients who have had or are suffering from other malignant tumors in the past (except for those who have been cured and have survived cancer-free for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma).
- Received any of the following treatments:a. Received any investigational drug within 4 weeks before the first use of the investigational drug; b. Enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study; c. Subjects who need to be given corticosteroids (≥ 10 mg prednisone equivalent per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergies, nausea and vomiting. Other special cases need to be communicated with the investigator. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal cortical hormone replacement with a dose of ≥ 10 mg/ day prednisone efficacy dose are allowed; d. Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug (if the new coronavirus vaccine is received, the interval between the vaccination and treatment must be more than 2 weeks) .
- Uncontrolled cardiac clinical symptoms or diseases, such as: a. NYHA grade II or above heart failure; b. Unstable angina; c. Myocardial infarction within 1 year; d. Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Severe infection ( CTCAE > 2 ) occurred within 4 weeks before the first use of the study drug , such as severe pneumonia, bacteremia, infectious complications requiring hospitalization, etc.; baseline chest imaging examination indicated active lung inflammation, symptoms and signs of infection within 4 weeks of the first use of the study drug, or the need for oral or intravenous antibiotic treatment.
- Patients with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excluding autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes using stable doses of insulin; patients with vitiligo or healed childhood asthma / allergy who do not require any intervention as adults.
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 |
|---|---|---|
| PembrolizumabTwo cycles of neoadjuvant pembrolizumab (200mg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of pembrolizumab (200mg q3w)maintenance therapy was given. | Drug | Perioperative pembrolizumab |
| IvonescimabTwo cycles of neoadjuvant Ivonescimab (10mg/kg q3w) followed by radical surgery. Adjuvant radiotherapy/chemoradiotherapy is decided based on pathological risk factors. Fifteen cycles of Ivonescimab maintenance therapy (10mg/kg q3w) was given. | Drug | Perioperative Ivonescimab |
| SurgeryRadical surgery | Procedure or surgery | Perioperative Ivonescimab, Perioperative pembrolizumab |
| Adjuvant radiotherapyAdjuvant radiotherapy with/without concurrent cisplatin-based chemotherapy, based on pathologic risk factors. | Radiation | Perioperative Ivonescimab, Perioperative pembrolizumab |
Primary outcome
Major pathological response
Time frame: 4 months
Major pathologic response, defined as ≤10% residual viable tumor in the resected primary tumor and lymph node tissue
5 secondary outcomes
Event-free survival rate
Time frame: One year
Overall survival rate
Time frame: One year
pCR rate
Time frame: 4 months
Overall response of neoadjuvant therapy
Time frame: 8 weeks
Adverse event
Time frame: From the time of randomization to 90 days after the last dose of immunotherapy.
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 7 Feb 2025.
- Background: PubMed 35338369Wise-Draper TM, Gulati S, Palackdharry S, Hinrichs BH, Worden FP, Old MO, Dunlap NE, Kaczmar JM, Patil Y, Riaz MK, Tang A, Mark J, Zender C, Gillenwater AM, Bell D, Kurtzweil N, Mathews M, Allen CL, Mierzwa ML, Casper K, Jandarov R, Medvedovic M, Lee JJ, Harun N, Takiar V, Gillison M. Phase II Clinical Trial of Neoadjuvant and Adjuvant Pembrolizumab in Resectable Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2022 Apr 1;28(7):1345-1352. doi: 10.1158/1078-0432.CCR-21-3351.
- Background: PubMed 32665297Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14.
- 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 Pembrolizumab, Ivonescimab and Surgery in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma HNSCC, run by Fudan 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 18 inclusion and 14 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: opening soon, as of the sponsor's last update on 7 Feb 2025. 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 Yu Wang, M.D., professor (+86-13611967175, neck130@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814067, which also lists 2 linked publications.
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 7 Feb 2025.