Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02426892|
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : December 20, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Biological: ISA 101 Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nivolumab and HPV-16 Vaccination in Patients With HPV-16-Positive Incurable Solid Tumors|
|Actual Study Start Date :||December 23, 2015|
|Actual Primary Completion Date :||November 30, 2021|
|Actual Study Completion Date :||November 30, 2021|
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.
Biological: ISA 101
100 mcg administered subcutaneously for a total of 3 doses at 3 to 4 weeks intervals starting on Day 1.
3 mg/kg administered by vein every 2 weeks beginning on Day 8 after the first vaccine dose.
- Overall Response Rate (ORR) [ Time Frame: 11 weeks ]ORR defined as sum of subjects with a complete response (CR) and partial response (PR) divided by number of evaluable subjects at 11 weeks from start of treatment. RECIST 1.1 criteria used for assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426892
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie S. Glisson, MD, BS||M.D. Anderson Cancer Center|