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

NCT02426892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-04-18

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

ISA 101

100 mcg administered subcutaneously for a total of 3 doses at 3 to 4 weeks intervals starting on Day 1.

DRUG

Nivolumab

3 mg/kg administered by vein every 2 weeks beginning on Day 8 after the first vaccine dose.

Sponsors & Collaborators

  • ISA Pharmaceuticals B.V.

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Bonnie S. Glisson, MD, BS · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-23
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426892 on ClinicalTrials.gov