Trial Summary
What is the purpose of this trial?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).
Eligibility Criteria
Adults with recurrent or metastatic head and neck squamous-cell carcinoma that worsened after PD-1/PD-L1 inhibitor therapy. They must be in good physical condition, have normal organ and bone marrow function, not be pregnant or breastfeeding, agree to use contraception, and have no history of severe allergies to similar drugs or serious autoimmune diseases.Inclusion Criteria
My kidney function is within the normal range.
My cancer can be measured by scans or physical exam.
I know my p16 status for my neck or oropharynx cancer.
My cancer is in the mouth, throat, or neck and has come back or spread.
My cancer can be measured by scans or physical exam.
I am fully active and can carry on all my pre-disease activities without restriction.
I know my p16 status for my neck or oropharynx cancer.
I am 18 years old or older.
My blood counts and liver/kidney functions are within normal ranges.
I am 18 years old or older.
My cancer is in the mouth, throat, or neck and has been confirmed by a lab test.
Exclusion Criteria
I have had an organ or stem cell transplant from a donor.
I haven't taken high doses of steroids or had severe autoimmune issues with PD-1 treatments.
I have an autoimmune disease but haven't needed strong medication for it in the last 6 months.
I do not have any serious illnesses that are not under control.
I do not have severe numbness or pain in my hands or feet.
I have been treated with a taxane for recurrent or metastatic disease.
Treatment Details
The trial is testing the effectiveness of combining nab-paclitaxel with nivolumab against this type of cancer. The goal is to see if this combination improves response rates and progression-free survival compared to past results from other treatments.
1Treatment groups
Experimental Treatment
Group I: nab-Paclitaxel + NivolumabExperimental Treatment2 Interventions
* 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.
nab-paclitaxel is already approved in United States, European Union, Australia for the following indications:
🇺🇸 Approved in United States as Abraxane for:
- Metastatic pancreatic adenocarcinoma
🇪🇺 Approved in European Union as Abraxane for:
- Metastatic pancreatic adenocarcinoma
🇦🇺 Approved in Australia as Abraxane for:
- Metastatic pancreatic adenocarcinoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
Loading ...
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
Bristol-Myers SquibbIndustry Sponsor