NCT05232851

Brief Summary

This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
5mo left

Started Jun 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jun 2022Sep 2026

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 16, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 14, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Expected
Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

January 31, 2022

Results QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus-Related CarcinomaLocally Advanced Oropharyngeal CarcinomaStage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Proportion of Pathologic and Human Papillomavirus Cell-free Tumor Deoxyribonucleic Acid (ctHPVDNA) Response

    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.

    2 years

Secondary Outcomes (4)

  • Progression-free Survival (PFS)

    2 years

  • Overall Survival (OS)

    2 years

  • Response Rate

    2 years

  • Incidence of Adverse Events (AEs)

    25 months

Study Arms (2)

Arm A (PDS0101)

EXPERIMENTAL

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.

Biological: Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101Procedure: Computed TomographyProcedure: FDG-Positron Emission TomographyProcedure: Biospecimen CollectionProcedure: Biopsy

Arm B (PDS0101, pembrolizumab)

EXPERIMENTAL

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.

Biological: Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101Biological: PembrolizumabProcedure: Computed TomographyProcedure: FDG-Positron Emission TomographyProcedure: Biospecimen CollectionProcedure: Biopsy

Interventions

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101BIOLOGICAL

Given SC

Also known as: mmunoMAPK-RDOTAP /HPV-16 E6/E7 Peptide Antigen Vaccine, PDS0101
Arm A (PDS0101)Arm B (PDS0101, pembrolizumab)
PembrolizumabBIOLOGICAL

Given IV

Also known as: BCD-201, Biosimilar BCD-201, Keytruda, Lambrolizumab, MK-3475, SCH 900475
Arm B (PDS0101, pembrolizumab)
Computed TomographyPROCEDURE

Undergo CT, FDG-PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography
Arm A (PDS0101)Arm B (PDS0101, pembrolizumab)
FDG-Positron Emission TomographyPROCEDURE

Undergo FDG-PET/CT

Also known as: FDG, FDG-PET, FDG-PET Imaging
Arm A (PDS0101)Arm B (PDS0101, pembrolizumab)
Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Arm A (PDS0101)Arm B (PDS0101, pembrolizumab)
BiopsyPROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx
Arm A (PDS0101)Arm B (PDS0101, pembrolizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years
  • Disease characteristics
  • Locally advanced HPV-OPSCC and high-risk HPV-specific testing with at least one of the following:
  • Radiology extranodal extension (ENE) OR
  • cN2 (AJCC 8th Edition) disease (contralateral/bilateral nodes) OR
  • cN3(AJCC 8th Edition) disease (lymph node \[LN\] \> 6 cm) OR
  • Radiographic evidence of 2 or more involved lymph nodes
  • Candidate for curative intent surgery or chemo-radiation
  • Measurable or unmeasurable disease as defined by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • White blood cell (WBC) count \>= 3,000/mm\^3 (=\< 15 days prior to registration)
  • Platelet count \>= 75,000/mm\^3 (=\< 15 days prior to registration)
  • Hemoglobin \>= 9.0 g/dL (5.6 mmol/L) (=\< 15 days prior to registration)
  • NOTE: Transfusions are not allowed =\< 7 days prior to registration
  • Total bilirubin =\< 1.5 X upper limit of normal (ULN) (or total bilirubin =\< 3.0 X ULN with direct bilirubin =\<1.5 X ULN in patients with well-documented Gilbert's Syndrome) (=\< 15 days prior to registration)
  • +10 more criteria

You may not qualify if:

  • Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • NOTE: Exceptions are allowed for:
  • Vitiligo
  • Resolved childhood asthma/atopy
  • Intermittent use of bronchodilators or inhaled steroids
  • Daily steroids at dose of =\< 10mg of prednisone (or equivalent)
  • Local steroid injections
  • Stable hypothyroidism on replacement therapy
  • Stable diabetes mellitus
  • Sjogren's syndrome
  • Any prior head or neck chemotherapy, radiotherapy, and/or immunotherapy
  • Any of the following prior therapies:
  • Live vaccine \< 30 days prior to registration, including intranasal flu vaccine (e.g. Flu-Mist®) (Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed
  • Chemotherapy or targeted small molecule therapy \< 21 days prior to registration
  • Investigational therapy or investigational device \< 30 days prior to registration
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Oropharyngeal NeoplasmsCarcinoma

Interventions

pembrolizumabSpecimen HandlingBiopsy

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Results Point of Contact

Title
David Routman
Organization
Mayo Clinic
routman.david@mayo.edu
507-284-2669

Study Officials

  • David M. Routman, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pathologist will be blinded to study treatment arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

June 16, 2022

Primary Completion

April 9, 2025

Study Completion (Estimated)

September 10, 2026

Last Updated

April 14, 2026

Results First Posted

April 14, 2026

Record last verified: 2026-03

Locations

US(1)