Health TrialsbyHealthPanel

Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

ConditionLocally Advanced Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMing-Yuan Chen

About this trial

This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form;

Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS ≥ 1, with clinical stage (AJCC 8th edition): p16-positive oropharynx: Stage III (T4N0-2M0); p16-negative oropharynx: Stage III or IVA; larynx/hypopharynx/oral cavity: Stage III or IVA;

Eligible for curative-intent surgery as determined by the surgeon;

Age: 18 to 75 years;

Disqualifiers

Pregnant or breastfeeding women.

History of allergy to PD-1 inhibitors.

History of other malignancies within the past 5 years or at enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary tumors.

Residual toxicity from prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, etc.) other than alopecia, fatigue, and grade 2 hypothyroidism, or clinically significant laboratory abnormalities greater than grade 1 (CTCAE v5.0).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant and Adjuvant Becotatug Vedotin

    Drug

    Neoadjuvant therapy with Becotatug Vedotin (Day 1, Q3W, 2 cycles); Adjuvant therapy after radiotherapy with Becotatug Vedotin ( Day 1, Q3W, for a total of 12 cycles).

  • Neoadjuvant and Adjuvant Immunotherapy

    Drug

    Neoadjuvant immunotherapy with pucotenlimab (200mg, Day 1, Q3W, 2 cycles); Adjuvant immunotherapy duiring and after radiotherapy with pucotenlimab (200mg, Day 1, Q3W, for a total of 15 cycles).

  • Surgery

    Procedure/Surgery

    Radical surgery performed 3-4 weeks after neoadjuvant therapy, following a re-evaluation of surgical indications by the surgeon.

  • Adjuvant Radiotherapy

    Radiation

    Radiotherapy is initiated 4-6 weeks after surgery. For the low-risk group, a total dose of 60 Gy in 30 fractions is delivered using intensity-modulated radiation therapy (IMRT). For the high-risk group, 66 Gy in 33 fractions is prescribed, or 70 Gy in 35 fractions for residual lesions, also using IMRT.

  • Adjuvant Cisplatin

    Drug

    High-risk group：Cisplatin 100 mg/m² is administered via intravenous infusion on Day 1 of every 21-day cycle during radiotherapy, for a total of 3 cycles.

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Becotatug vedotin plus pucotenlimab armExperimental treatment 5 interventions
Group B: pucotenlimab armActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Event-Free Survival Rate (EFS)

Defined as the time from randomization to the first occurrence of disease progression, relapse, or death from any cause.

Time frame
3 years

Secondary outcomes

1

Overall Survival (OS)

Defined as the time interval from randomization to death due to any cause.

Time frame
3 years
2

Distant Metastasis-Free Survival (DMFS)

Defined as the time interval from randomisation to the date of first distant metastases.

Time frame
3 years
3

Locoregional Relapse-Free Survival (LRRFS)

Defined as the time from randomisation to the date of first locoregional relapse.

Time frame
3 years
4

Objective Response Rate (ORR)

The proportion of patients achieving an objective response (complete response and partial response) by imaging assessment after the completion of neoadjuvant therapy, prior to surgery.

Time frame
After the completion of neoadjuvant therapy, prior to surgery.

Other outcomes

Sponsors and contacts

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

Ming-Yuan Chen

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
Apply now