A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or … (NCT07435324) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
Russia161 participantsStarted 2024-08-08
Plain-language summary
The primary objective of the study is to evaluate the comparability of efficacy, safety, and immunogenicity of RPH-002 and Erbitux® when administered in combination with docetaxel and cisplatin as first-line therapy in patients with advanced head and neck squamous cell carcinoma
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A voluntarily signed and dated Informed Consent form (ICF) of the patient
✓. Histologically confirmed squamous cell carcinoma of the head and neck
✓. Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed \>3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy
✓. At least one measurable lesion per RECIST 1.1
✓. Karnofsky performance status ≥70%
✓. Screening laboratory values within the following limits (per local lab normal ranges):
✓. Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt
✓. Ability and willingness to comply with study protocol and procedures for the planned duration of participation
Exclusion criteria
✕. Prior therapy with cetuximab or other monoclonal antibody-based biologics
✕. Chemotherapy, radiotherapy, or surgery for head and neck cancer within 3 months before screening
What they're measuring
1
Objective response rate (%) (ORR)
Timeframe: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
✕. Any other surgery (except biopsy, implantable venous port placement, or urgent non-cancer surgery) within 3 months before screening
✕. Nasopharyngeal carcinoma
✕. Other malignancy within the past 5 years or prior/concurrent squamous cell carcinoma (except cured in situ ductal carcinoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer)
✕. Expected survival \< 3 months
✕. Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after
✕. Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure