TerminatedPhase 2

Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer

Stopped: Closed the trial for infeasibility due to slow accrual

United States3 participantsStarted 2018-04-04

Plain-language summary

The goal of this clinical research study is to learn if utomilumab, when given with ISA101b, is able to shrink or slow the growth of tumors in patients with incurable HPV+ oropharyngeal squamous cell carcinoma. This is an investigational study. Utomilumab and ISA101b are not FDA approved or commercially available. They are currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work. Up to 27 participants will be enrolled. All will take part at MD Anderson.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
✓. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
✓. Men and women \>/= 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of \</= 1.
✓. Subjects with histologically- or cytologically-documented incurable Human Papillomavirus (HPV)-positive OPSCC. HPV-16 serotype will be assessed by Cervista assay.
✓. Subjects can be treatment naïve or may have had two prior regimens for recurrent cancer. They must be naive to treatment with PD-1/L1 or CTLA-4 inhibitors.
✓. Subjects must have progression within 6 months of platin exposure during definitive or palliative therapy.
✓. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria; Radiographic Tumor Assessment performed within 28 days of study inclusion.

Exclusion criteria

What they're measuring

Overall Response Rate (ORR) of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Timeframe: 9 weeks from start of treatment

Trial details

NCT IDNCT03258008

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-05

Results submitted2022-11-01

View on ClinicalTrials.gov More Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites trials