Trial Outcomes & Findings for Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer (NCT NCT03258008)
NCT ID: NCT03258008
Last Updated: 2022-12-16
Results Overview
Overall Response Rate assessed by RECIST 1.1 Criteria
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
9 weeks from start of treatment
Results posted on
2022-12-16
Participant Flow
Recruitment Period: April 2018 to February 2019-Closed the trial for infeasibility due to slow accrual
3 Participants registered to the trial, 1 was not eligible as screen fail.
Participant milestones
| Measure |
Utomilumab and ISA101b
Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Utomilumab and ISA101b
n=3 Participants
Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeks from start of treatmentOverall Response Rate assessed by RECIST 1.1 Criteria
Outcome measures
| Measure |
Utomilumab and ISA101b
n=2 Participants
Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer
|
|---|---|
|
Overall Response Rate (ORR) of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
0 percentage of participants
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Baseline, and continuously throughout the study at the beginning of each subsequent cycle up to 2 yearsAdverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for grades 1-3.
Outcome measures
| Measure |
Utomilumab and ISA101b
n=2 Participants
Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer
|
|---|---|
|
Adverse Events of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Grade 1
|
13 adverse events
|
|
Adverse Events of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Grade 2
|
0 adverse events
|
|
Adverse Events of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Grade 3
|
0 adverse events
|
SECONDARY outcome
Timeframe: Every-8-week schedule beginning from the first on-study assessment on Week 9 up to 2 yearsPopulation: No data collected for Response Rate by irRC of Utomilumab Combined with ISA 101b in Patients with Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC).
Response rate monitored by radiographic assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every-8-week schedule beginning from the first on-study assessment on Week 9 up to 2 yearsPFS defined as the time from first day of treatment to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause.
Outcome measures
| Measure |
Utomilumab and ISA101b
n=2 Participants
Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer
|
|---|---|
|
Progression Free Survival (PFS) of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
1.84 months
Interval 1.84 to
not estimable
|
Adverse Events
Utomilumab and ISA101b
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Utomilumab and ISA101b
n=2 participants at risk
Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Endocrine disorders
Endocrine disorders - Other, specify Increased TSH Levels
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Infections and infestations
Infections and infestations - Other, specify Rhinitis
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 1 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify pain at injection site
|
50.0%
1/2 • Number of events 2 • Adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent, through study completion an average of 24 months.
|
Additional Information
Dr. John Heymach, PHD-Chair, Thoracic-Head & Neck Med Onc
UT MD Anderson Cancer Center
Phone: (713) 792-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place