Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04831320
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Head-and-neck Squamous-cell Carcinoma

Eligibility Criteria

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

Interventions

  • nab-paclitaxel — DRUG
    Supplied by Celgene Corporation
  • Nivolumab — DRUG
    Supplied by Bristol-Myers Squibb

Study Details

The primary hypothesis is that the objective response rate (ORR) with nab-paclitaxel and nivolumab will be significantly higher than the historical control (ORR 30%). The KEY secondary hypothesis is that the median PFS with nab-paclitaxel and nivolumab will be significantly longer than the historical control (median PFS 3.6 months).

Key Dates

Start date
Sep 28, 2021
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nab-Paclitaxel + Nivolumab
    * nab-Paclitaxel 125 mg/m\^2 intravenous (IV) on days 1, 8 \& 15 of each 28-day cycle. * Nivolumab 480 mg IV Day 1 of each 28-day cycle.

Primary Outcome Measure

Objective response rate (ORR) as assessed by RECIST 1.1 [ Time Frame: Through completion of treatment (estimated to be 4 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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