Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC

This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.

Trial Details

NCT ID
NCT06935188
Phase
PHASE2
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Dalpicilib combined with cetuximab
  • cetuximab
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Age 18-75 years, both sexes.
  • Patients with histologically confirmed post-surgical recurrent/metastatic or locally advanced inoperable surgically resectable squamous cell carcin…
  • Have received at least 1 cycle of prior PD-1 immunotherapy with imaging confirmation of progression or clinician determination of no continued bene…
  • HPV viral testing determined to be negative, using the IHC method.

For full eligibility, visit ClinicalTrials.gov.

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