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Compares treatment options for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official title Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck
ClinicalTrials.gov ID: NCT06959108
What this study is testing
What is Pucotenlimab?
Pucotenlimab is an investigational medicine, being studied as a potential treatment for locally advanced 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
- The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy. People eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy).
- Phase 2: a mid-size study of how well it works
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
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Evaluable tumor burden assessed by H\&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1
- Patients eligible to cisplatin-based chemotherapy
- No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5
- No prior treatment with chemotherapy, immunotherapy and targeted therapy for H\&N cancer, radiotherapy or surgery in the head and neck region.
You likely can't join if
- Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
- Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug...
- Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment
- History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer...
- Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment)...
- Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
See the full eligibility criteria
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Evaluable tumor burden assessed by H\&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1
- Patients eligible to cisplatin-based chemotherapy
- No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5
- No prior treatment with chemotherapy, immunotherapy and targeted therapy for H\&N cancer, radiotherapy or surgery in the head and neck region.
- Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
- Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).
- Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment
- History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast...
- Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina...
- Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including...
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
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 Villejuif, France. 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.