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Compares treatment options for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Official title Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC
ClinicalTrials.gov ID: NCT06935188
What this study is testing
What is Dalpicilib combined with cetuximab?
Dalpicilib combined with cetuximab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for recurrent/metastatic head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years, both sexes.
- Patients with histologically confirmed post-surgical recurrent/metastatic or locally advanced inoperable surgically resectable squamous cell...
- Have received at least 1 cycle of prior PD-1 immunotherapy with imaging confirmation of progression or clinician determination of no continued...
- HPV viral testing determined to be negative, using the IHC method.
- Availability of tumor tissue (paraffin specimens less than 2 years old or fresh tumor tissue) for detection of PD-L1 and CDK4-related genes.
You likely can't join if
- Patients previously treated with cetuximab or other anti-EGFR monoclonal antibodies or small molecule tyrosine kinase inhibitors.
- Patients who are currently receiving antineoplastic therapy.
- Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of the study...
- Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1...
- Positive HIV antibody or syphilis spirochete antibody test results.
- Patients with active hepatitis B or C: If positive for HBsAg or HBcAb, additional HBV DNA testing (results above the upper limit of the normal...
See the full eligibility criteria
- Age 18-75 years, both sexes.
- Patients with histologically confirmed post-surgical recurrent/metastatic or locally advanced inoperable surgically resectable squamous cell carcinoma of the head and neck with measurable lesions (spiral CT scan ≥ 10...
- Have received at least 1 cycle of prior PD-1 immunotherapy with imaging confirmation of progression or clinician determination of no continued benefit from treatment; provided that this is completed at least 4 weeks...
- HPV viral testing determined to be negative, using the IHC method.
- Availability of tumor tissue (paraffin specimens less than 2 years old or fresh tumor tissue) for detection of PD-L1 and CDK4-related genes.
- ECOG score of 0 or 1.
- Expected survival of ≥ 12 weeks.
- Normal major organ function within 2 weeks prior to treatment, i.e., meeting the following criteria：Bone marrow function: hemoglobin ≥ 100 g/L without transfusion or colony-stimulating factor support therapy, white...
- Patients previously treated with cetuximab or other anti-EGFR monoclonal antibodies or small molecule tyrosine kinase inhibitors.
- Patients who are currently receiving antineoplastic therapy.
- Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of the study drug.
- Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first dose of the study drug.
- Positive HIV antibody or syphilis spirochete antibody test results.
- Patients with active hepatitis B or C: If positive for HBsAg or HBcAb, additional HBV DNA testing (results above the upper limit of the normal range). If HCV antibody test result is positive, add HCV RNA test (result...
- Known hypersensitivity to recombinant humanized EGFR monoclonal antibody drugs and their components.
- Massive pleural or ascites fluid with clinical symptoms and requiring symptomatic management.
- Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis.
- Has any uncontrollable clinical problem, including but not limited to: Persistent or active (severe) infection; Poorly controlled diabetes mellitus; Cardiac disease (Class III/IV congestive heart failure or heart block...
- Previous stem cell transplantation or organ transplantation.
- Those with a history of psychotropic substance abuse and unable to abstain or a history of psychiatric disorders.
- Other serious, acute or chronic medical conditions or abnormalities in laboratory tests that, in the judgment of the investigator, may increase the risk associated with study participation or may interfere with the...
- Patients who, in the judgment of the investigator, have poor compliance or other conditions that make them unsuitable for participation in this trial.
- Patients with a history of other malignancies within five years.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.