A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor
Lei Liu
Study ID
NCT06444009
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab combined with TP — DRUG
    Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
  • Cadonilimab combined with TP — DRUG
    Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
  • Penpulimab combined with TP — DRUG
    Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.

Study Details

A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.

Key Dates

Start date
Jul 1, 2024
Status verified
Nov 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab in combination with Nab-paclitaxel + Cisplatin
    Neoadjuvant: Patients receive ivonescimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: pCR: Patients receive adjuvant ivonescimab for 16 cycles. no pCR: Low/ Medium Risk: Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles High Risk: All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles.
  • Experimental: Cadonilimab in combination with Nab-paclitaxel + Cisplatin
    Neoadjuvant: Patients receive cadonilimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: pCR: Patients receive adjuvant cadonilimab for 16 cycles. no pCR: Low/ Medium Risk: Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles High Risk: All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles.
  • Experimental: Penpulimab in combination with Nab-paclitaxel + Cisplatin
    Neoadjuvant: Patients receive penpulimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery. Surgery: Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection. Adjuvant: pCR: Patients receive adjuvant penpulimab for 16 cycles. no pCR: Low/ Medium Risk: Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles High Risk: All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles.

Primary Outcome Measure

pCR [ Time Frame: After surgery (approximately 9-10 weeks after start of study treatment) ]

Central Contacts

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