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MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC

ConditionsNasopharyngeal CarcinomaLocal Recurrence
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Cancer Hospital

About this trial

This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg/m², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with locally recurrent nasopharyngeal carcinoma (NPC) more than 1 year after initial radical treatment for non-metastatic NPC, with or without regional recurrence, but without distant metastasis.

Age 18-70 years.

Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification.

ECOG performance status score of 0-1.

Disqualifiers

Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions.

Residual toxic effects from prior anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than Grade 1 (CTCAE v5.0).

Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥10 copies/ml), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay).

Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.

Trial design

Design model

Single group

Treatments tested in this trial

  • MRG003

    Drug

    MRG003 at 2.0 mg/kg (D1) will be administered every three weeks for 6 cycles

  • Tislelizumab

    Drug

    Tislelizumab 200 mg (D1) will be administered every three weeks for 6 cycles. Upon achieving an objective response, maintenance therapy will continue for up to one year or until disease progression is observed.

  • Capecitabine

    Drug

    After achieving an objective response (ORR) with the combination of MRG003 and Tislelizumab, maintenance therapy will consist of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: MRG003Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

The Objective Response Rate (ORR) is defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) by Day 21 after the completion of six cycles of MRG003 treatment, starting from the date of enrollment.

Time frame
Day 21 after the completion of six cycles of MRG003 treatment

Secondary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as the time from enrollment to the date of tumor progression or death from any cause, or to the date of the last follow-up if no progression has occurred.

Time frame
1-year; 3-year
2

Overall Survival (OS)

OS is defined as the time from enrollment to the date of death from any cause, or to the date of the last follow-up if no death has occurred.

Time frame
1-year; 3-year
3

Duration of Response (DOR)

DOR is defined as the time from the first assessment of Complete Response (CR) or Partial Response (PR) to the first assessment of Progressive Disease (PD) or death from any cause

Time frame
1-year; 3-year
4

Disease Control Rate (DCR)

DCR is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment.

Time frame
Day 21 after the completion of six cycles of MRG003 treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: