NCT07618624

Brief 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 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
41mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Dec 2029

Study Start

First participant enrolled

April 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

May 25, 2026

Last Update Submit

May 25, 2026

Conditions

Recurrent Head and Neck Squamous Cell CarcinomaHead and Neck Cancer

Keywords

FinotonlimabSCT-I10ACetuximabDocetaxelNeoadjuvant TherapyRecurrent Head and Neck CancerBRIDGEImmunotherapy ProgressionSalvage SurgeryMajor Pathological ResponsePD-1 InhibitorEGFR Inhibitor

Outcome Measures

Primary Outcomes (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.

    At time of surgery, approximately 12 weeks after enrollment

Secondary Outcomes (9)

  • Objective Response Rate (ORR)

    After 3 cycles of neoadjuvant therapy, approximately 9 weeks

  • Pathological Complete Response Rate (pCR)

    At time of surgery

  • Median Overall Survival (mOS)

    Up to 60 months from enrollment

  • Median Progression-Free Survival (mPFS)

    Up to 60 months from enrollment

  • Duration of Response (DoR)

    Up to 60 months

  • +4 more secondary outcomes

Study Arms (1)

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel

EXPERIMENTAL

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel

Drug: FinotonlimabDrug: CetuximabDrug: DocetaxelProcedure: Salvage SurgeryRadiation: Adjuvant RadiotherapyDrug: Platinum-based Chemotherapy

Interventions

FinotonlimabDRUG

Finotonlimab

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
CetuximabDRUG

Cetuximab

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
DocetaxelDRUG

Docetaxel

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
Salvage SurgeryPROCEDURE

Surgical resection after neoadjuvant therapy.

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
Adjuvant RadiotherapyRADIATION

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

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
Platinum-based ChemotherapyDRUG

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

Neoadjuvant Finotonlimab + Cetuximab + Docetaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The First People's Hospital of Foshan

Foshan, Guangdong, China

Location

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Location

Related Publications (5)

  • 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.

    PMID: 38942993BACKGROUND

  • 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.

    PMID: 34667025BACKGROUND

  • 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.

    PMID: 38833968BACKGROUND

  • 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.

    PMID: 31679945BACKGROUND

  • 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.

    PMID: 27718784BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Interventions

CetuximabDocetaxelRadiotherapy, AdjuvantPlatinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCombined Modality TherapyTherapeuticsRadiotherapyInorganic Chemicals

Study Officials

  • Xuekui Liu, MD, PhD

    Sun Yat-Sen University Cancer Center

    STUDY CHAIR

  • Chunyan Chen, MD, PhD

    Sun Yat-Sen University Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

June 1, 2026

Record last verified: 2026-03

Locations

CN(9)