BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression

Conditions

• Head and Neck Cancer
• Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Finotonlimab — DRUG
  Finotonlimab
• Cetuximab — DRUG
  Cetuximab
• Docetaxel — DRUG
  Docetaxel
• Salvage Surgery — PROCEDURE
  Surgical resection after neoadjuvant therapy.
• Adjuvant Radiotherapy — RADIATION
  Adjuvant radiotherapy: after surgery, the team will assess whether the patient has indications for radiotherapy to determine whether to administer it.
• Platinum-based Chemotherapy — DRUG
  Adjuvant chemotherapy determined by team assessment of chemotherapy indications after surgery.

Study Details

This is a multicenter, single-arm, phase II clinical study evaluating the efficacy and safety of neoadjuvant finotonlimab (anti-PD-1), cetuximab (anti-EGFR), and docetaxel in patients with resectable recurrent head and neck squamous cell carcinoma (HNSCC) who have progressed after prior PD-1(L1) inhibitor plus platinum-based therapy. A total of 42 patients (PD-L1 CPS at least 1) will be enrolled using Simon's two-stage design across 9 centers in China (Stage 1: 25 patients; Stage 2: 17 additional patients with 5% dropout). Enrolled patients will receive 3 cycles of neoadjuvant finotonlimab (200 mg, IV, Q3W), cetuximab (500 mg/m2, IV, Q3W), and docetaxel (75 mg/m2, IV, Q3W), followed by salvage surgery (3-4 weeks later), adjuvant radiotherapy +/- chemotherapy per NCCN/CSCO guidelines, and maintenance finotonlimab 200 mg + cetuximab 500 mg/m2 Q3W for up to 12 cycles or until disease progression or unacceptable toxicity. The primary endpoint is major pathological response (MPR) rate. Historical MPR is 14% with dual immunotherapy neoadjuvant therapy; target MPR is 30% (alpha=0.05, power=0.8, one-sided). Secondary endpoints include ORR, pCR, mOS, mPFS, DoR, 6-month and 12-month PFS rate, and safety (AEs/SAEs per CTCAE v5.0).

Key Dates

First listed

Jun 1, 2026

Start date

Apr 20, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
  Neoadjuvant Finotonlimab + Cetuximab + Docetaxel

Primary Outcome Measure

Major Pathological Response Rate (MPR) [ Time Frame: At time of surgery, approximately 12 weeks after enrollment ]

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