Recruiting NCT06976190
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRG003 + Pucotenlimab, Gemcitabine, Docetaxel, or Capecitabine.
- Who it may be relevant to
- Registry conditions: Recurrent or Metastatic Nasopharyngeal Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Overview
This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.
Interventions
- Drug MRG003 + Pucotenlimab
MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol. - Drug Gemcitabine, Docetaxel, or Capecitabine
Gemcitabine will be administrated via intravenous infusion at 1000 mg/m2 once on Day 1 and 8 of every 3 weeks (21-day cycle). Docetaxel will be administrated via intravenous infusion at 75 mg/m2 once on Day 1 of every 3 weeks (21-day cycle). Capecitabine will be administrated orally at 1000 mg/m2 twice a day for Day 1 to 14 of every 3 weeks (21-day cycle).
Primary outcome measures
- Progression Free Survival (PFS) as assessed by BIRC [Time frame: Baseline to study completion (up to 33 months)]
- Overall Survival (OS) [Time frame: Baseline to study completion (up to 48 months)]
Secondary outcome measures (6)
- Objective Response Rate (ORR) [Time frame: Baseline to study completion (up to 48 months)]
- Disease Control Rate (DCR) [Time frame: Baseline to study completion (up to 48 months)]
- Progression Free Survival (PFS) as assessed by investigator [Time frame: Baseline to study completion (up to 33 months)]
- Immunogenicity (ADA) [Time frame: Baseline to 14 days after the last dose.]
- Adverse Events (AEs) [Time frame: Baseline to 30 days after the last dose of study treatment]
- Serious Adverse Events (SAEs) [Time frame: Baseline to 30 days after the last dose of study treatment]
Eligibility criteria
Inclusion criteria
- Willing to sign the informed consent form and follow the requirements specified in the protocol.
- Life expectancy ≥ 12 weeks.
- Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy.
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- The score of ECOG for performance status is 0 or 1.
- No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%.
- Organ functions and coagulation function must meet the basic requirements.
- Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Exclusion criteria
- History of hypersensitivity to any component of the investigational product.
- Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment.
- Received anti-infection therapy within 2 weeks prior to the randomization
- Prior treatment with MMAE/MMAF ADC drugs
- Central nervous system metastasis.
- Poorly controlled systemic diseases
- Patients with poorly controlled heart diseases
- Poorly controlled pleural and peritoneal effusion or pericardial effusion
- ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
- Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)
- Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months
- Received allogeneic tissue/solid organ transplantation.
- Inoculate live vaccine within 30 days before the first dose.
- Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
- History of other primary malignant tumor diseases.
- Other situations that are not suitable to participate a clinical trial per investigator's judgement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06976190 · HX008/MRG003-C002