A Study of Docetaxel for Injection (Albumin-bound) in Combination With Nivolumab in Patients With Head and Neck (SCCHN)

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT05027204
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Docetaxel for Injection (Albumin-bound), Q3W, i.v. 60 min
  • Nivolumab — DRUG
    Nivolumab, Q3W, i.v. 30 min

Study Details

This trial is a single-arm, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Nivolumab and the pharmacokinetic characteristics of Docetaxel in patients with recurrent or metastatic SCCHN who are positive for PD-L1 expression and have progressed on or after platinum-based therapy.

Key Dates

Start date
Mar 4, 2022
Status verified
Jan 2022
Primary completion
Oct 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
94 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel combined with Nivolumab
    Phase Ib: The eligible patients with SCCHN will received Docetaxel for Injection (Albumin-bound) 75 mg/m\^2 or 100 mg/m\^2 sequentially in combination with Nivolumab 360 mg to evaluate safety and efficacy and explore RP2D. Phase II: According to the RP2D determined in the phase Ib study, patients will be treated with Docetaxel for Injection (Albumin-bound) combined with Nivolumab until participants meet the criteria for termination or withdrawal criteria, for a maximum of 2 years.

Primary Outcome Measure

Phase Ib: Incidence of adverse events and serious adverse events [ Time Frame: 6 weeks ]

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