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NCT02426892 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT02426892: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02426892 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02426892, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
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. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG Nivolumab
- BIOLOGICAL ISA 101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 2 |
What the finished NCT02426892 record still lists
NCT02426892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02426892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02426892 about?
NCT02426892 is a clinical study titled "Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors". 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 f...
What is the current status of trial NCT02426892?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2015-12-23. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT02426892?
The interventions under investigation include: Nivolumab (DRUG), ISA 101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02426892?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02426892's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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