CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
ISA 101 +1 morebiological
Likely dose
ISA 101 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02426892
NCT02426892Phase 2Completed
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Phase II Trial of Nivolumab and HPV-16 Vaccination in Patients With HPV-16-Positive Incurable Solid Tumors

M.D. Anderson Cancer Center·interventional·Posted Apr 27, 2015·Updated Apr 18, 2023

In Brief

A Phase 2 clinical trial evaluating ISA 101 and Nivolumab for Solid Tumors. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesUnited States
CollaboratorsISA Pharmaceuticals B.V., Bristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 27, 2015
Enrollment StartDec 23, 2015
Primary CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.2 years ago

Interventions

ISA 101biological

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

Nivolumabdrug

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