SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer
A Single-arm, Multicenter, Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With QL1706 for Recurrent or Metastatic Cervical Cancer
Sponsor: Fujian Cancer Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Secondary Endpoints
Overall Survival(OS)
Progression Free Survival(PFS)
Duration of Response(DoR)
Eligibility Criteria
Inclusion Criteria: * Female, aged ≥18 years at the time of signing the informed consent form; * Diagnosed with recurrent or metastatic cervical cancer \[pathological types include squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, etc., with pathological report provided\], and not suitable for radical treatments such as surgery or radiotherapy. Patients will be divided into the following two cohorts based on pathological type: * Cohort 1: Cervical squamous cell carcinoma; * Cohort 2: Cervical non-squamous carcinoma (including adenocarcinoma or adenosquamous carcinoma, and other types of cervical cancer) * Have experienced failure of at least one prior line of platinum-based standard therapy or intolerance to platinum-based drugs in the recurrent or metastatic setting, or have experienced radiologically confirmed disease progression during or within 6 months after completion (≥4 cycles) of platinum-based neoadjuvant or adjuvant chemotherapy. Specific requiremen…
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