ACTIVE_NOT_RECRUITING

A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer

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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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Stimulating Immune Response With Neoadjuvant Human Papilloma Virus (HPV)-16 Specific Vaccination in HPV-Oropharyngeal Squamous Cell Carcinoma (HPV-OPSCC)

Quick Facts

Study Start:2022-06-16
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05232851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Disease characteristics
  3. * Locally advanced HPV-OPSCC and high-risk HPV-specific testing with at least one of the following:
  4. * Radiology extranodal extension (ENE) OR
  5. * cN2 (AJCC 8th Edition) disease (contralateral/bilateral nodes) OR
  6. * cN3(AJCC 8th Edition) disease (lymph node \[LN\] \> 6 cm) OR
  7. * Radiographic evidence of 2 or more involved lymph nodes
  8. * Candidate for curative intent surgery or chemo-radiation
  9. * Measurable or unmeasurable disease as defined by RECIST 1.1 criteria
  10. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  11. * White blood cell (WBC) count \>= 3,000/mm\^3 (=\< 15 days prior to registration)
  12. * Platelet count \>= 75,000/mm\^3 (=\< 15 days prior to registration)
  13. * Hemoglobin \>= 9.0 g/dL (5.6 mmol/L) (=\< 15 days prior to registration)
  14. * NOTE: Transfusions are not allowed =\< 7 days prior to registration
  15. * 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)
  16. * Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) =\< 2.5 X ULN (=\< 15 days prior to registration)
  17. * Creatinine =\< 1.5 mg/dL (133 umol/L) OR calculated creatinine clearance \>= 30 mL/min/1.73m\^2 for patients with creatinine levels above ULN (=\< 15 days prior to registration)
  18. * Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =\< 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of anticoagulants (=\< 15 days prior to registration)
  19. * Negative pregnancy test done =\< 3 days prior to registration for persons of childbearing potential only
  20. * Persons of childbearing potential or able to father a child must be willing to use an effective method of contraception for the course of the study starting with the first dose of study therapy through 120 days after the last dose of study medication
  21. * NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred method of contraception for the patient
  22. * Provide written informed consent
  23. * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  24. * Willingness to provide mandatory blood specimens for correlative research
  25. * Willingness to provide mandatory tissue specimens for correlative research
  1. * Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  2. * NOTE: Exceptions are allowed for:
  3. * Vitiligo
  4. * Resolved childhood asthma/atopy
  5. * Intermittent use of bronchodilators or inhaled steroids
  6. * Daily steroids at dose of =\< 10mg of prednisone (or equivalent)
  7. * Local steroid injections
  8. * Stable hypothyroidism on replacement therapy
  9. * Stable diabetes mellitus
  10. * Sjogren's syndrome
  11. * Any prior head or neck chemotherapy, radiotherapy, and/or immunotherapy
  12. * Any of the following prior therapies:
  13. * 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
  14. * Chemotherapy or targeted small molecule therapy \< 21 days prior to registration
  15. * Investigational therapy or investigational device \< 30 days prior to registration
  16. * Any prior investigational HPV-specific therapeutic vaccine
  17. * Current or prior use of immunosuppressive medication \< 14 days prior to registration
  18. * The following are exceptions to this criterion:
  19. * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection)
  20. * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  21. * Steroids as premedication for hypersensitivity reactions (e.g., premedication for computed tomography \[CT\] scans)
  22. * Uncontrolled intercurrent illness including, but not limited to:
  23. * Ongoing or active infection requiring systemic therapy
  24. * Interstitial lung disease
  25. * Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others)
  26. * Known active hepatitis B (i.e., known positive HBV surface antigen (HBsAg) reactive)
  27. * Known active hepatitis C (i.e., positive for HCV ribonucleic acid \[RNA\] detected by polymerase chain reaction \[PCR\])
  28. * Known human immunodeficiency virus (HIV) (Note: Patients on stable highly active antiretroviral therapy (HAART) for \>= 6 weeks with CD4 counts \>= 200 cells/mm\^3 undetectable HIV viral load by quantitative PCR and no opportunistic infections Castlemaan's Disease =\< 12 months prior to enrollment are allowed)
  29. * Known active tuberculosis (TB)
  30. * Symptomatic congestive heart failure
  31. * Unstable angina pectoris
  32. * Unstable cardiac arrhythmia or
  33. * Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse)
  34. * History of allogeneic hematopoietic transplant or any solid organ transplant
  35. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  36. * Other active malignancy \< 2 years prior to registration
  37. * EXCEPTIONS: Non-melanotic skin cancer (SCC/BCC), micropapillary thyroid cancer, Gleason 6 prostate cancer, carcinoma-in-situ of the breast or cervix
  38. * Any of the following conditions =\< 6 weeks prior to registration:
  39. * Cerebrovascular accident (CVA)
  40. * Admission for unstable angina
  41. * Cardiac angioplasty or stenting or coronary artery bypass graft surgery
  42. * Untreated pulmonary embolism or untreated deep venous thrombosis (DVT)
  43. * Arterial thrombosis
  44. * Receipt of immunotherapy/immunomodulatory or immunosuppressive agents (e.g., IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biologic response modifiers \[GM-CSF, GCSF\] =\< 6 weeks prior to registration

Contacts and Locations

Principal Investigator

David M. Routman, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • David M. Routman, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-16
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-06-16
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Human Papillomavirus-Related Carcinoma
  • Locally Advanced Oropharyngeal Carcinoma
  • Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8