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Recurrent Head and Neck Squamous Cell CarcinomaPhase 2BRIDGENCT07618624

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

A Phase 2 study testing Finotonlimab, Cetuximab and Docetaxel in people with Recurrent Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by Sun Yat-sen University at 9 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Finotonlimab, Cetuximab and Docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
9 sitesChina
Study dates
20 Apr 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Age 18-75 years at time of consent
  • Histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma with PD-L1 CPS at least 1
  • Disease progression after prior treatment including both PD-1(L1) inhibitor and platinum-based therapy (combined or sequential)
  • No EGFR-targeted therapy within 6 months prior to enrollment
  • Willing to provide archived tumor tissue or undergo fresh tumor biopsy for PD-L1 testing
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  • At least one measurable extracranial lesion per RECIST v1.1; previously treated lesions must demonstrate clear progression 3 or more months after last local treatment
  • Resectable disease with no distant metastasis, as assessed by a multidisciplinary team
  • Adequate organ function within 7 days prior to enrollment: ANC at least 2.0 x 10^9/L, platelet count at least 100 x 10^9/L; total bilirubin less than 1.5 x ULN, ALT/AST less than 2.5 x ULN; serum creatinine less than 1.5 x ULN
  • Signed informed consent prior to any study-specific procedures
  • Life expectancy greater than 3 months
  • Effective contraception during study and for 6 months after last dose

Who cannot join

  • History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ)
  • Comorbidities requiring long-term immunosuppressive therapy or corticosteroids at immunosuppressive doses
  • Immunodeficiency or history of organ transplantation (including interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism)
  • HIV/AIDS; untreated active hepatitis B (HBV-DNA at least 500 IU/mL); hepatitis C (HCV-RNA above detection limit); or HBV/HCV co-infection
  • High-dose systemic corticosteroids within 4 weeks prior to enrollment
  • Pregnant or lactating women; fertile patients not using effective contraception
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  • Laboratory values not meeting inclusion criteria within 7 days
  • Significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function
  • Severe uncontrolled comorbidities or active infections
  • Concurrent participation in other clinical trials
  • Refusal or inability to sign informed consent
  • Other contraindications to study treatment as determined by the investigator
  • Psychiatric disorders or mental illness resulting in lack of legal capacity

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

9 sites in 1 country

China9 sites

  • The First People's Hospital of Foshan

    Foshan, Guangdong

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

Other trials in China

About this study

Official title: Finotonlimab Combined With Cetuximab and Docetaxel as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Immunotherapy Progression: A Multicenter, Single-Arm, Phase II Clinical Study

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).

Read the detailed description

Recurrent head and neck squamous cell carcinoma (HNSCC) remains a significant clinical challenge, with recurrence rates of 40-60% after curative treatment. Salvage surgery is the standard of care, yet approximately 50% of patients experience re-recurrence within 2 years. For patients who have progressed on prior PD-1 inhibitor and platinum-based therapy, no standard neoadjuvant regimen exists.

Finotonlimab (SCT-I10A) is a recombinant humanized anti-PD-1 monoclonal antibody approved by NMPA for first-line R/M HNSCC in combination with platinum-based chemotherapy. Phase III data showed mOS 14.1 months and ORR 39.9% (Nature Medicine, 2024). Cetuximab is an anti-EGFR monoclonal antibody approved for R/M HNSCC. Cetuximab plus taxane regimens showed ORR of 54.9-69.6% as second-line therapy after immunotherapy failure. Retrospective data suggest EGFR inhibition may enhance anti-tumor immune response and improve efficacy of PD-1 rechallenge (ORR 46.4%). Docetaxel is a standard taxane chemotherapeutic agent.

This study investigates a novel neoadjuvant triplet regimen combining finotonlimab (immunotherapy), cetuximab (EGFR targeting), and docetaxel (chemotherapy) in resectable recurrent HNSCC after immunotherapy progression.

TREATMENT REGIMEN:

  1. Neoadjuvant: Finotonlimab 200 mg IV + Cetuximab 500 mg/m2 IV + Docetaxel 75 mg/m2 IV, Q3W, 3 cycles
  2. Surgery: Salvage surgery 3-4 weeks after neoadjuvant completion
  3. Adjuvant: IMRT (60-66 Gy/30f) +/- platinum-based chemotherapy per NCCN/CSCO
  4. Maintenance: Finotonlimab 200 mg IV + Cetuximab 500 mg/m2 IV Q3W for 12 cycles or until progression/toxicity

Simon's two-stage design: Stage 1 (25 patients; at least 3 MPR required to proceed) to Stage 2 (17 additional, total 42). H0 MPR=14%, H1 MPR=30% (alpha=0.05, power=0.8). If 9 or fewer total responses, the trial is considered negative.

Being tested
Finotonlimab, Cetuximab, Docetaxel, Salvage Surgery, Adjuvant Radiotherapy
Keywords
Finotonlimab, SCT-I10A, Cetuximab, Docetaxel, Neoadjuvant Therapy, Recurrent Head and Neck Cancer, BRIDGE, Immunotherapy Progression, Salvage Surgery, Major Pathological Response, PD-1 Inhibitor, EGFR Inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FinotonlimabDrug

    Finotonlimab

  • CetuximabDrug

    Cetuximab

  • DocetaxelDrug

    Docetaxel

  • Salvage SurgeryProcedure or surgery

    Surgical resection after neoadjuvant therapy.

  • Adjuvant RadiotherapyRadiation

    Adjuvant radiotherapy: after surgery, the team will assess whether the patient has indications for radiotherapy to determine whether to administer it.

  • Platinum-based ChemotherapyDrug

    Adjuvant chemotherapy determined by team assessment of chemotherapy indications after surgery.

Study groups in NCT07618624
Study groupRoleWhat they receive
Neoadjuvant Finotonlimab + Cetuximab + DocetaxelExperimentalNeoadjuvant Finotonlimab + Cetuximab + Docetaxel
Receives: Drug: Finotonlimab; Drug: Cetuximab; Drug: Docetaxel; Procedure: Salvage Surgery; Radiation: Adjuvant Radiotherapy; Drug: Platinum-based Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathological Response Rate (MPR)

    Proportion of patients with less than or equal to 10% viable tumor cells in the surgically resected specimen after neoadjuvant therapy, assessed by central pathology review.

    Measured: At time of surgery, approximately 12 weeks after enrollment

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.

    Measured: After 3 cycles of neoadjuvant therapy, approximately 9 weeks

  2. Pathological Complete Response Rate (pCR)

    Proportion of patients with no residual viable tumor cells in the surgically resected specimen.

    Measured: At time of surgery

  3. Median Overall Survival (mOS)

    Time from enrollment to death from any cause.

    Measured: Up to 60 months from enrollment

  4. Median Progression-Free Survival (mPFS)

    Time from enrollment to disease progression per RECIST v1.1 or death from any cause.

    Measured: Up to 60 months from enrollment

  5. Duration of Response (DoR)

    Time from first documented CR or PR to disease progression or death.

    Measured: Up to 60 months

  6. 6-Month Progression-Free Survival Rate

    Proportion of patients alive without disease progression at 6 months after completion of study treatment.

    Measured: 6 months after end of treatment

  7. 12-Month Progression-Free Survival Rate

    Proportion of patients alive without disease progression at 12 months after completion of study treatment.

    Measured: 12 months after end of treatment

  8. Incidence of Adverse Events (AEs)

    Safety assessed per NCI CTCAE v5.0. Incidence and severity of all AEs, treatment-emergent AEs, and immune-related AEs.

    Measured: Through study completion, up to 90 days after last dose

  9. Incidence of Serious Adverse Events (SAEs)

    Incidence of serious adverse events assessed per CTCAE v5.0.

    Measured: Through study completion, up to 90 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start20 Apr 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618624
Sponsor's protocol ID
2025-FXY-430
Acronym
BRIDGE
Status last verified
Mar 2026
First submitted
25 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shi Y, Guo W, Wang W, Wu Y, Fang M, Huang X, Han P, Zhang Q, Dong P, Zhou X, Peng H, Hu C, Chen X, Zhang S, Chang Z, Li X, Ding Y, Qu S, Jing S, Zhang S, Gui L, Sun Y, Wang L, Liu Y, Wu H, Li G, Fu Z, Shi J, Jiang H, Bai Y, Cui J, Zheng Y, Cui W, Jia X, Zhai L, Cai Q, Xiong D, Wu Y, Cao J, Wu R, Hu G, Peng L, Xie L, Gai W, Wang Y, Su Y. Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial. Nat Med. 2024 Sep;30(9):2568-2575. doi: 10.1038/s41591-024-03110-7. Epub 2024 Jun 28.

    PubMed 38942993

  • Hanna GJ, O'Neill A, Shin KY, Wong K, Jo VY, Quinn CT, Cutler JM, Flynn M, Lizotte PH, Annino DJ Jr, Goguen LA, Kass JI, Rettig EM, Sethi RKV, Lorch JH, Schoenfeld JD, Margalit DN, Tishler RB, Everett PC, Desai AM, Cavanaugh ME, Paweletz CP, Egloff AM, Uppaluri R, Haddad RI. Neoadjuvant and Adjuvant Nivolumab and Lirilumab in Patients with Recurrent, Resectable Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Feb 1;28(3):468-478. doi: 10.1158/1078-0432.CCR-21-2635. Epub 2021 Oct 19.

    PubMed 34667025

  • Koyama T, Kiyota N, Boku S, Imamura Y, Shibata N, Satake H, Tanaka K, Hayashi H, Onoe T, Asada Y, Yamazaki T, Nose T, Ohata S, Nagatani Y, Kimbara S, Funakoshi Y, Teshima M, Shinomiya H, Minami H. A phase II trial of paclitaxel plus biweekly cetuximab for patients with recurrent or metastatic head and neck cancer previously treated with both platinum-based chemotherapy and anti-PD-1 antibody. ESMO Open. 2024 Jun;9(6):103476. doi: 10.1016/j.esmoop.2024.103476. Epub 2024 Jun 3.

    PubMed 38833968

  • Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.

    PubMed 31679945

  • Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.

    PubMed 27718784

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Finotonlimab, Cetuximab and Docetaxel in people with Recurrent Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by Sun Yat-sen University at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response Rate (MPR) (time frame: At time of surgery, approximately 12 weeks after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07618624, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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