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Becotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma.

ConditionNasopharyngeal Carcinoma (NPC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHongmeng Yu

About this trial

This study plans to enroll patients with histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma. After signing informed consent, eligible subjects will receive three cycles of standard-dose becotatug vedotin combined with a PD-1 inhibitor. Following treatment, imaging assessment and surgical evaluation will be performed. Subjects deemed operable will undergo endoscopic nasal surgery, after which the MDT (multidisciplinary team) will discuss and determine a maintenance treatment plan. For subjects who are not eligible for surgery, the MDT will decide on either maintenance therapy or a switch to an alternative treatment regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained prior to any trial-related procedures.

≥ 18 years of age.

Histologically or cytologically confirmed recurrent nasopharyngeal carcinoma (locoregional recurrence and/or regional lymph node recurrence), without distant metastases. Including patients with local recurrence at T2 stage and/or retropharyngeal lymph node metastasis adjacent to the internal carotid artery.

At least one lesion at baseline meeting RECIST 1.1 criteria for target lesions (TL). Tumor assessment must be performed by CT or MRI scan within 28 days before treatment.

Disqualifiers

Diagnosis of any malignancy other than nasopharyngeal carcinoma within 5 years prior to first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically resected).

Prior treatment with an ADC drug containing MMAE as the payload.

Known active bleeding signs of the lesion under endoscopy.

Currently participating in an interventional clinical study, or having received another investigational drug or used an investigational device within 4 weeks prior to first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • Becotatug Vedotin

    Drug

    Becotatug vedotin 2.0 mg/kg, intravenous infusion, once every 3 weeks

  • PD-1 / PD-L1 monoclonal antibody

    Drug

    PD-1 immune checkpoint inhibitor, administered according to the prescribing information of the investigator's chosen agent.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: becotatug vedotin + PD-1 inhibitorExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
12 weeks
2

1-year and 2-year progression-free survival (PFS) rates

Time frame
end of 1st year, end of 2nd year

Secondary outcomes

1

1-year and 2-year overall survival (OS) rates

Time frame
end of 1st year, end of 2nd year
2

pCR rate, R0 resection rate, and resectability rate

Time frame
week 16 after enrollment day
3

1-year and 2-year locoregional recurrence-free survival (LRFS) rates

Time frame
end of 1st year, end of 2nd year
4

1-year and 2-year distant metastasis-free survival (DMFS) rates

Time frame
end of 1st year, end of 2nd year

Other outcomes

Sponsors and contacts

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

Hongmeng Yu

Lead sponsor

Eye & ENT Hospital of Fudan University

Sponsor institution

Source ClinicalTrials.gov
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