Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 2NCT06530914
A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing MRG003 combined with Pucotenlimab and MRG003 combined with Pucotenlimab+Cisplatin in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Lei Liu.
Trial summary
A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- MRG003 combined with Pucotenlimab and MRG003 combined with Pucotenlimab+Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent voluntarily and follow the requirements of the program;
- Age ≥18 years old, ≤70 years old, gender is not limited;
- Physical condition score ECOG 0 or 1;
- Histopathology confirmed the diagnosis of head and neck squamous cell carcinoma, and immunohistochemistry confirmed that EGFR expression was positive (defined as weak staining of > 10% of tumor cells);
- No previous treatment for head and neck squamous cell carcinoma, including drug therapy, radiotherapy, surgery, etc., and the tumors of the subjects assessed by the researchers before admission could be surgically resected;
- According to the American Joint Committee on Cancer (AJCC) /TNM Staging System eighth Edition, patients must have the following tumor stages: 1) patients with stage III, IVA, and IVB non-oropharyngeal cancer and patients with HPV-negative oropharyngeal cancer; Or 2) Stage II and III HPV-positive oropharyngeal cancer patients. For patients with oropharyngeal cancer, HPV status should be determined by p16 IHC.
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- The level of organ function must meet the following requirements:
- Bone marrow: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L, and no blood transfusion or biological response regulator (such as granulocyte, erythrocyte growth factor, etc.) treatment within 14 days before the first dose;
- Liver: total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5×ULN; Serum albumin ≥28 g/L;
- Kidney: creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula);
- Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN (except those receiving therapeutic anticoagulants);
- No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%;
- Fertile men and women of childbearing age are willing to take effective contraceptive measures from the signing of informed consent to 6 months after the last administration of the experimental drug; Women of reproductive age include premenopausal women and women within 1 year after menopause. Blood pregnancy test results for women of childbearing age must be negative within ≤7 days before the first trial drug administration.
Who cannot join
- Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);
- Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);
- Have received any of the following treatments:
- Received intravenous antibiotic therapy within 7 days prior to initial dosing;
- Investigational drugs that have received other clinical trials within 4 weeks prior to initial dosing;
- have received live attenuated vaccine within 4 weeks prior to first administration, and are allowed to receive inactivated seasonal influenza vaccine or approved COVID-19 vaccine without live virus;
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- Received systemic immunostimulatory drugs (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to initial administration;
- Had major surgery (e.g., transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, or digestive home implantation) within 4 weeks prior to initial dosing, or expected to require major surgery during the study period; Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways;
- A history of other primary malignancies within the past 3 years, excluding basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has been completely and radically resected;
- Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke/myocardial infarction, unstable angina, congestive heart failure (NYHA Class II and above), or severe arrhythmia requiring medication within the first 6 months of enrollment;
- Evidence of active infection includes hepatitis B (HBsAg positive with HBV DNA≥2000 IU/ml, excluding hepatitis due to drugs or other causes), hepatitis C (HCV positive with anti-HCV antibody), hepatitis B (HCV positive with HBV DNA≥2000 IU/ mL), and hepatitis C (HCV positive with HBV DNA≥2000 IU/ mL). HCV RNA results greater than the lower limit of detection) or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsial, or parasitic infections, unless treated and resolved prior to administration of the investigational drug;
- Loss of more than 10% of body weight in the 4 weeks prior to the first dose (unless appropriate nutritional support measures are taken);
- Active gastrointestinal bleeding, or bleeding requiring more than 2 red blood cell transfusions or 4 units of compressed red blood cell transfusions within the first 4 weeks;
- Patients with a history of primary immunodeficiency or active autoimmune disease who were taking immunosuppressants or systemic hormone therapy (dose ≥10 mg/ day of prednisone or other equivalent hormone) and continued to use it within 2 weeks prior to enrollment; Attention: Patients with type I diabetes, stable hypothyroidism with hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis, vitiligo, or psoriasis that does not require systemic treatment may be enrolled with topical or inhaled corticosteroids, or short-term (≤7 days) corticosteroids for prevention or treatment of non-autoimmune diseases. And infrequent allergic diseases are excluded. ;
- A history of grade 3 allergy to any component of MRG003, Ptrelizumab injection, and/or cisplatin injection;
- Previous history of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;
- History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful evaluation, patients who received autologous hematopoietic stem cell transplantation (HSTC) ≥ 5 years ago and who have normal bone marrow function (independent of transfusion) may be considered for study participation;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator, including but not limited to serious mental illness, central nervous disorder, substance abuse, etc.
About this study
A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.
Read the detailed description
In this study, eligible patients will be randomized in a 1:1 ratio to either the MRG003 Injection Combined With Pucotenlimab Injection treatment group (Cohort 1), or the MRG003 Injection Combined With Pucotenlimab Injection + Cisplatin treatment group (Cohort 2). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.
- Being tested
- MRG003 combined with Pucotenlimab, MRG003 combined with Pucotenlimab+Cisplatin
- Keywords
- Locally Advanced EGFR-positive HNSCC, Neoadjuvant therapy, Antibody-drug conjugate, immunotherapy, chemotherapy
- 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.
MRG003 combined with PucotenlimabDrug
Also called MRG003+Pucotenlimab
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
MRG003 combined with Pucotenlimab+CisplatinDrug
Also called MRG003+Pucotenlimab+Cisplatin
All interventions all drugs intravenous infusion, once every 3 weeks, a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| MRG003+Pucotenlimab | Experimental | Neoadjuvant:
Patients receive MRG003 in combination with Pucotenlimab for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
Patients receive adjuvant Pucotenlimab for 8 cycles. Receives: Drug: MRG003 combined with Pucotenlimab |
| MRG003+Pucotenlimab+Cisplatin | Experimental | Neoadjuvant:
Patients receive MRG003 in combination with Pucotenlimab + cisplatin for 3 cycles before surgery.
Surgery:
Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Adjuvant:
Patients receive adjuvant Pucotenlimab for 8 cycles. Receives: Drug: MRG003 combined with Pucotenlimab+Cisplatin |
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 (6)
EFS EFS
Event free survival
Measured: 1 years
ORR
Objective response rate
Measured: 9-10 weeks
OS
Overall survival
Measured: 2 years
Number of patients with Adverse Events (AEs)
79/5000 The incidence, severity and correlation of adverse events (AE), serious adverse events (SAE), immune-related adverse events (irAE), and laboratory index outliers were determined according to NCI-CTCAE v5.0 standards
Measured: Up to approximately 1 years
Incidence of surgery-related AE/SAE (adverse events/serious adverse events)
Rate of delayed or canceled surgery, length of surgery, length of hospital stay, method of surgery, and incidence of surgery-related AE/SAE (adverse events/serious adverse events) within 90 days after surgery
Measured: 90 days
Proportion of reduction in clinical stage after treatment
The proportion of clinical stage reduction after combination therapy in the target study population
Measured: 9-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 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 Carcinoma (HNSCC)Studies 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
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06530914
- Sponsor's protocol ID
- MP-HNC-II-007
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06530914
- Acronym / sponsor ID
- MP-HNC-II-007
- Keywords
- Locally Advanced EGFR-positive HNSCC, Neoadjuvant therapy, Antibody-drug conjugate, immunotherapy, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lei LiuUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 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 MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.
Detailed description
In this study, eligible patients will be randomized in a 1:1 ratio to either the MRG003 Injection Combined With Pucotenlimab Injection treatment group (Cohort 1), or the MRG003 Injection Combined With Pucotenlimab Injection + Cisplatin treatment group (Cohort 2). 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
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG003+Pucotenlimab | Experimental | Drug: MRG003 combined with PucotenlimabNeoadjuvant: Patients receive MRG003 in combination with Pucotenlimab for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: Patients receive adjuvant Pucotenlimab for 8 cycles. |
| MRG003+Pucotenlimab+Cisplatin | Experimental | Drug: MRG003 combined with Pucotenlimab+CisplatinNeoadjuvant: Patients receive MRG003 in combination with Pucotenlimab + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: Patients receive adjuvant Pucotenlimab for 8 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign the informed consent voluntarily and follow the requirements of the program;
- Age ≥18 years old, ≤70 years old, gender is not limited;
- Physical condition score ECOG 0 or 1;
- Histopathology confirmed the diagnosis of head and neck squamous cell carcinoma, and immunohistochemistry confirmed that EGFR expression was positive (defined as weak staining of > 10% of tumor cells);
- No previous treatment for head and neck squamous cell carcinoma, including drug therapy, radiotherapy, surgery, etc., and the tumors of the subjects assessed by the researchers before admission could be surgically resected;
Key exclusion criteria (18 listed)
- Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);
- Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);
- Have received any of the following treatments:
- A history of other primary malignancies within the past 3 years, excluding basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has been completely and radically resected;
- Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke/myocardial infarction, unstable angina, congestive heart failure (NYHA Class II and above), or severe arrhythmia requiring medication within the first 6 months of enrollment;
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 |
|---|---|---|
| MRG003 combined with PucotenlimabAlso: MRG003+PucotenlimabBoth interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles. | Drug | MRG003+Pucotenlimab |
| MRG003 combined with Pucotenlimab+CisplatinAlso: MRG003+Pucotenlimab+CisplatinAll interventions all drugs intravenous infusion, once every 3 weeks, a total of 3 cycles. | Drug | MRG003+Pucotenlimab+Cisplatin |
Primary outcome
pCR
Time frame: After surgery (approximately 9-10 weeks after start of study treatment)
Pathological complete response rate
6 secondary outcomes
EFS EFS
Time frame: 1 years
ORR
Time frame: 9-10 weeks
OS
Time frame: 2 years
Number of patients with Adverse Events (AEs)
Time frame: Up to approximately 1 years
Incidence of surgery-related AE/SAE (adverse events/serious adverse events)
Time frame: 90 days
Proportion of reduction in clinical stage after treatment
Time frame: 9-10 weeks
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 31 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG003 combined with Pucotenlimab and MRG003 combined with Pucotenlimab+Cisplatin in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Lei Liu.
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 18 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 31 Jul 2024.