HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04432597
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRGN-2009 — BIOLOGICAL
    On the phase I portion of the protocol PRGN-2009 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. The dose level given as booster will be the same dose participants will be receiving for D1, D15 and D29. On the phase II portion of the protocol PRGN-2009 will be administered on just D1 and D15 for Cohort 1/Arm 1A, Cohort 2/Arm 1B, Cohort 3/Arm 2A, and Cohort 4/Arm2B.
  • M7824 — BIOLOGICAL
    Subjects enrolled to Cohort 2/Arm 1B will receive M7824 (MSB0011359C) via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.
  • EKG — DIAGNOSTIC_TEST
    Screening, end of treatment and follow-up.
  • Biopsy — PROCEDURE
    For immune analysis: Baseline Day 1 and odd numbered weeks (week(W) 1, W3, W5, W7 onwards.
  • CT Scan — DIAGNOSTIC_TEST
    CT scan chest, abdomen, pelvis, neck, and/or skull as clinically indicated. Tumor evaluation at screening, baseline Day 1, odd numbered weeks (week(W) 1, W3, W5, W7 onwards. Long term follow-up.
  • MRI — DIAGNOSTIC_TEST
    Tumor evaluation at screening, baseline Day 1, odd numbered weeks (week(W) 1, W3, W5, W7 onwards. Long term follow-up.
  • Brain CT — DRUG
    Screening. As clinically indicated in participants with known central nervous system (CNS) disease.
  • Brain MRI — DRUG
    Screening. As clinically indicated in participants with known central nervous system (CNS) disease.
  • Dexamethasone — DRUG
    Dexamethasone 10mg for hypersensitivity reactions.
  • Epinephrine — DRUG
    1:1,000 dilution for hypersensitivity reactions.
  • Diphenhydramine — DRUG
    Antihistamines (e.g., Diphenhydramine) given intravenously for allergy.
  • Ibuprofen — DRUG
    For flu-like symptoms. 400mg or comparable Nonsteroidal anti-inflammatory drugs (NSAID) dose, may be administered 2 hours before and 8 hours after the start of each intravenous infusion.

Study Details

Background: For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on these cancers than when they work alone. Objective: To find a safe dose of HPV vaccine alone or combined with M7824. Also, to test if either HPV vaccine alone or combined with M7824 causes a better immune response. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer (Phase I) or stage II or III p16-positive oropharyngeal cancer (Phase II) Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Possible photos of skin lesions Computed tomography (CT), magnetic resonance imaging (MRI), or nuclear bone scan: Participants will lie in a machine that takes pictures of the body. For the CT scan, they may have a contrast agent injected into a vein. Participants may have up to 2 tumor biopsies. For participants in Phase II, this may be performed with a thin tube placed through the nose into the airway. Participants will receive the HPV vaccine alone or with M7824. For participants on the Phase II, they will receive two doses of HPV vaccine under the skin either alone or with M7824 as an infusion spaced two weeks apart. This will be done prior to their planned chemoradiation or surgery. For participants on the Phase I, they will get the HPV vaccine injected under the skin 2 to 3 times in the first month. Then they will have a booster every 4 weeks. They will receive M7824 as an infusion into a vein every 2 weeks. Treatment will last up to 1 year. After they stop treatment, participants will have a visit within 4 weeks. They will then be contacted for long-term follow-up every year, for the rest of their lives. ...

Key Dates

Start date
Aug 11, 2020
Status verified
May 2026
Primary completion
Nov 22, 2022
Completion
May 29, 2026

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Arm 1A
    Human Papillomavirus Vaccine (HPV) vaccine at 1x10(11) Viral Particles (VP) Dose Level 1 (DL1) and at 5x10(11) VP Dose Level 2 (DL2)
  • Experimental: 2/Arm 1B
    Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) plus M7824 at 1200 mg.
  • Experimental: 3/Arm 2A
    Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) given as neoadjuvant or induction therapy.
  • Experimental: 4/Arm 2B
    Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) plus M7824 at 1200 mg given as neoadjuvant or induction therapy.

Primary Outcome Measure

Safety and recommended phase II dose of PRGN-2009 [ Time Frame: one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By condition
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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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