Trial Outcomes & Findings for A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer (NCT NCT05232851)
NCT ID: NCT05232851
Last Updated: 2026-04-14
Results Overview
Will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method for each arm separately.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
Arm A (PDS0101)
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Baseline characteristics by cohort
| Measure |
Arm A (PDS0101)
n=10 Participants
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
n=10 Participants
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 7.00 • n=193 Participants
|
63.2 years
STANDARD_DEVIATION 9.28 • n=193 Participants
|
62.2 years
STANDARD_DEVIATION 8.07 • n=386 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
18 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 2 yearsWill be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method for each arm separately.
Outcome measures
| Measure |
Arm A (PDS0101)
n=10 Participants
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
n=10 Participants
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
|---|---|---|
|
Proportion of Pathologic and Human Papillomavirus Cell-free Tumor Deoxyribonucleic Acid (ctHPVDNA) Response
|
0.5 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: 2 yearsPatients who receive the study drug, but then never return for an evaluation will be censored on their last follow-up date. PFS will be estimated using the method of Kaplan-Meier. PFS rates at 12 and 24 months will also be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOS will be estimated using the method of Kaplan Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsWill be estimated using Response Evaluation Criteria in Solid Tumors 1.1 criteria. A tumor response is defined to be either a complete response or partial response noted up until surgery. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. Patients who go off study early before having a tumor assessment performed will be considered a failure.
Outcome measures
| Measure |
Arm A (PDS0101)
n=10 Participants
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
n=10 Participants
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
|---|---|---|
|
Response Rate
|
0 proportion of participants
|
0.2 proportion of participants
|
SECONDARY outcome
Timeframe: 25 monthsAll patients that have initiated treatment will be considered evaluable for AE analyses. The number of patients with grade 3 or higher events reported, regardless of attribution, will be reported here.
Outcome measures
| Measure |
Arm A (PDS0101)
n=10 Participants
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
n=10 Participants
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
|---|---|---|
|
Incidence of Adverse Events (AEs)
|
1 Participants
|
2 Participants
|
Adverse Events
Arm A (PDS0101)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm B (PDS0101, Pembrolizumab)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (PDS0101)
n=10 participants at risk
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
n=10 participants at risk
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
|---|---|---|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
Other adverse events
| Measure |
Arm A (PDS0101)
n=10 participants at risk
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
Arm B (PDS0101, Pembrolizumab)
n=10 participants at risk
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
30.0%
3/10 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
40.0%
4/10 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
20.0%
2/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
20.0%
2/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Ear and labyrinth disorders
Ear pain
|
30.0%
3/10 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
20.0%
2/10 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
20.0%
2/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
General disorders
Fatigue
|
60.0%
6/10 • Number of events 7 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
60.0%
6/10 • Number of events 6 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
20.0%
2/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
20.0%
2/10 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
General disorders
Injection site reaction
|
100.0%
10/10 • Number of events 92 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
100.0%
10/10 • Number of events 113 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
General disorders
Malaise
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
20.0%
2/10 • Number of events 3 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Creatinine increased
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Investigations - Other, specify
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
30.0%
3/10 • Number of events 4 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
20.0%
2/10 • Number of events 2 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
10.0%
1/10 • Number of events 1 • Adverse events were followed for 25 months and mortality was followed for 39 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place