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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.
EU CTIS ID: 2023-510558-18-00
What this study is testing
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 alone before chemoradiotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years, ≤ 75 years
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Histologically confirmed diagnosis in previously untreated LA-SCCHN patients suitable for definitive CRT : Stage III, IVA or IVB for oral cavity, hypopharynx, larynx or oropharynx (p16 negative) according to the American Joint Committee on Cancer [AJCC]/TNM Staging System, 8th Ed.) Or Irrespective of tobacco consumption: T3-T4/N1-N3 p16 positive oropharyngeal squamous cell carcinoma (OPSCC) (p16 protein overexpression assessed by immunohistochemistry). Or Only if tobacco consumption ≥ 20 pack - years: T1-T2/N1-N3 or T3-T4/N0 p16 positive OPSCC.
- 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 NCI-CTCAE v.5).
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 specifically targeting T-cell 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 cancer, or completely resected in-situ non-muscular invasive bladder, cervix, uterine and/or prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum/anus.
- 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, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction < 50%.
- Other active infections (viral and/or bacterial and/or mycotic) requiring systemic treatment at the day before randomization
See the full eligibility criteria
Who can join
- Age ≥ 18 years, ≤ 75 years
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Histologically confirmed diagnosis in previously untreated LA-SCCHN patients suitable for definitive CRT : Stage III, IVA or IVB for oral cavity, hypopharynx, larynx or oropharynx (p16 negative) according to the American Joint Committee on Cancer [AJCC]/TNM Staging System, 8th Ed.) Or Irrespective of tobacco consumption: T3-T4/N1-N3 p16 positive oropharyngeal squamous cell carcinoma (OPSCC) (p16 protein overexpression assessed by immunohistochemistry). Or Only if tobacco consumption ≥ 20 pack - years: T1-T2/N1-N3 or T3-T4/N0 p16 positive OPSCC.
- 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 NCI-CTCAE v.5).
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization: a. Polynuclear neutrophils >1.5 x 109/L b. Platelets > 100 x 109/L c. Hemoglobin > 9.0 g/dL d. ALAT/ASAT< 3.0 x ULN e. Total bilirubin < 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL) f. Glomerular filtration rate ≥ 50 mL/min/1.73m² (using the CKD-EPI creatinine formula [see Appendix 4])
- No prior treatment with chemotherapy, immunotherapy and targeted therapy for H&N cancer, radiotherapy or surgery in the head and neck region.
What rules you out
- 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 T-cell 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 cancer, or completely resected in-situ non-muscular invasive bladder, cervix, uterine and/or prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum/anus.
- 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, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction < 50%.
- Other active infections (viral and/or bacterial and/or mycotic) requiring systemic treatment at the day before randomization
- Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support).
- 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 chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.