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Immunotherapy

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

Phase 2

Waitlist Available

Led By Bonnie S. Glisson, BS,MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every-8-week schedule beginning from the first on-study assessment on week 9 up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with HPV+ oropharyngeal squamous cell carcinoma who have progressed despite prior platinum therapy.

Eligible Conditions

Oral Cancers
Oropharyngeal Cancer
Cancer of Unknown Primary

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every-8-week schedule beginning from the first on-study assessment on week 9 up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every-8-week schedule beginning from the first on-study assessment on week 9 up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every-8-week schedule beginning from the first on-study assessment on week 9 up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Adverse Events of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Progression Free Survival (PFS) of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

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

Side effects data

From 2023 Phase 1 & 2 trial • 5 Patients • NCT03318900

100%

Abdominal distension

100%

Anemia

50%

Dizziness

50%

Fatigue

50%

Hypotension

50%

Urine output decreased

50%

White blood cell decreased

100%

80%

60%

40%

20%

Study treatment Arm

Dose Level 2

Dose Level 1

Dose Level 3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Utomilumab + ISA101bExperimental Treatment2 Interventions

Utomilumab by vein every 4 weeks for up to 12 doses beginning on Cycle 1 Day 1. ISA101b as an injection under the skin every 4 weeks for 3 doses. Participants receive 2 injections each time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ISA101b

2021

Completed Phase 2

~120

Utomilumab

2017

Completed Phase 2

~30