Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02426892
Phase
PHASE2
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • ISA 101 — BIOLOGICAL
    100 mcg administered subcutaneously for a total of 3 doses at 3 to 4 weeks intervals starting on Day 1.
  • Nivolumab — DRUG
    3 mg/kg administered by vein every 2 weeks beginning on Day 8 after the first vaccine dose.

Study Details

The goal of this clinical research study is to learn if nivolumab combined with ISA101 can help to control cancer that has spread. The safety of the study drugs will also be studied. This is an investigational study. ISA101 is not FDA approved or commercially available. It is currently being used for research purposes only. Nivolumab is FDA approved to treat certain types of melanoma in patients who no longer respond to other drugs. Combining ISA101 with nivolumab is investigational. The study doctor can explain how the study drugs are designed to work. Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
Dec 23, 2015
Status verified
Dec 2022
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021

Study Design

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

Arms

  • Experimental: ISA101 + Nivolumab
    HPV-16 vaccination (ISA 101) administered subcutaneously at 100 mcg for a total of 3 doses at 3 to 4 weeks intervals starting on Day 1. Nivolumab administered intravenously at 3 mg/kg every 2 weeks beginning on day 8 after the first vaccine dose. There are 3 weeks in Cycle 1 and 2 weeks in Cycles 2 and beyond.

Primary Outcome Measure

Number of Participants With Overall Response Rate (ORR) [ Time Frame: From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 4.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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