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NCT06319963

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 5 months later.

See at-risk trials from Theravectys S.A.

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 3 words
    • Primary completion pushed from Jun 2026 to Dec 2026
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Study description expanded, about 52 wordsv7
  3. Primary completion date: Dec 2025 to Jun 2026v6
  4. Study sites: 3 to 4v5
  5. Site details revised at 3 of 3 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 3v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Aug 8, 2024
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety and Tolerability
Timeframe: 12 months after last injection
OBD
Timeframe: 28 days after last injection

Secondary (2)

Immunogenicity
PD-L1 expression

Arms and interventions

Arm A : Refractory newly diagnosedExperimental

Refractory recurrent and/or metastatic cervical or oropharyngeal cancer that is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy).

Arm B : newly diagnosed locally advancedExperimental

Participants who have newly diagnosed locally advanced HPV-related oropharyngeal cancer (defined by AJCC 8th edition \[ie, T1-2N2-N3, T3-T4N0-N3\]) or cervical cancer (stages IB to IVA) that has never been treated with curative intent, and who are candidates to begin an SoC treatment (surgery, radiation therapy with or without chemotherapy).

Drugs: Two IM injections Lenti-HPV-07, One IM injection Lenti-HPV-07

Sites

4 sites in 1 country