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A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

ConditionRecurrent or Metastatic Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLepu Biopharma Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRG003 + Pucotenlimab

    Drug

    MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.

  • Gemcitabine, Docetaxel, or Capecitabine

    Drug

    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).

Treatment groups

446 Participants
are divided into 2 treatment groups
Group A: MRG003 + PucotenlimabExperimental treatment 1 intervention
Group B: Chemotherapy ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) as assessed by BIRC

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 33 months)
2

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 48 months)

Secondary outcomes

1

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 according to RECIST v1.1.

Time frame
Baseline to study completion (up to 48 months)
2

Disease Control Rate (DCR)

DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.

Time frame
Baseline to study completion (up to 48 months)
3

Progression Free Survival (PFS) as assessed by investigator

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 33 months)
4

Immunogenicity (ADA)

The proportion of patients with positive ADA results.

Time frame
Baseline to 14 days after the last dose.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lepu Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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