A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLepu Biopharma Co., Ltd.
About this trial
The objective of this study is to compare the efficacy and safety of MRG003 versus cetuximab/methotrexate as second/third line of therapy in patients with RM-SCCHN who have previously failed PD-1 (L1) inhibitors and platinum-based therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females of childbearing potential (who are not surgically sterile or postmenopausal for < 1 year) who are willing to use adequate and reliable contraception such as avoidance of heterosexual activity, sterilization, oral contraceptives, injectable contraceptives, intrauterine devices, condoms, etc., during the study until 180 days after the last dose of study drug.
Male patients who are willing to use latex condoms during any sexual contact with females of childbearing potential during treatment until 180 days after the last treatment, even if vasectomy has been successfully performed. Reservation of semen specimen prior to the first dose of study treatment is recommended for fertile males for potential future conception.
Disqualifiers
1. Grade ≥2 peripheral neuropathy per CTCAE v5.0. 2. Is expected to require surgery or any other form of systemic or local anti-tumor therapy during the study, including maintenance therapy or radiotherapy (including palliative therapy, except for palliative therapy for non-target lesions) for SCCHN.
Progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache;
Evidence of enlarging brain metastases by MRI at least 4 weeks prior to the first dose and corticosteroids is required for at least 14 days prior to study drug treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
MRG003
DrugAdministered intravenously
Cetuximab injection
DrugAdministered intravenously
Methotrexate Injection
DrugAdministered intravenously
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: MRG003Experimental treatment 1 intervention
Group B: cetuximab/ methotrexateActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame
Baseline to study completion (up to 24 months)Secondary outcomes
1
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame
Baseline to study completion (up to 24 months)2
Objective Response Rate (ORR)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.
Time frame
Baseline to study completion (up to 24 months)3
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.
Time frame
Baseline to study completion (up to 24 months)4
Duration of Response (DOR)
DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
Time frame
Baseline to study completion (up to 24 months)Sponsors and contacts
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Source ClinicalTrials.gov