Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma

Sponsor
Åslaug Helland
Study ID
NCT04300244
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Cancer
  • Cancer of Lung
  • Cancer, Lung
  • Mesothelioma
  • Mesothelioma; Lung
  • Mesothelioma; Pleura
  • Mesotheliomas Pleural

Eligibility Criteria

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

Interventions

  • UV1 vaccine + leukine — BIOLOGICAL
    The mode of action of UV1 is to activate the immune system to induce T cells directed against telomerase (hTERT). UV1 vaccination amplifies the pool of hTERT specific tumor-reactive T cells from the naive repertoire and has the potential to increase the breadth and diversity of the tumor-reactive T cell response (epitope spreading). Vaccination with UV1 can thus provide the basis for increased efficacy of checkpoint inhibition therapy, by augmenting the pool of tumor specific T cells in patients with limited or insufficient numbers of T cell clones spontaneously primed by tumor antigens. Reciprocally, the efficacy of UV1 vaccination may be enhanced in combination with checkpoint inhibitors, since the clonal expansion and effector activity of UV1 induced T cells will otherwise be restricted by intrinsic immune regulatory and tumor induced suppressor mechanisms.
  • ipilimumab — BIOLOGICAL
    The responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.
  • nivolumab — BIOLOGICAL
    The responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.

Study Details

The objective of the study is to induce a meaningful progression-free survival benefit in patients with Malign Pleural Mesothelioma (MPM) after progression on first line standard platinum doublet chemotherapy, by treating with nivolumab and ipilimumab with or without UV1 vaccine.

Key Dates

Start date
May 4, 2020
Status verified
Feb 2024
Primary completion
Mar 15, 2025
Completion
Mar 15, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Ipilimumab and nivolumab + UV1
  • Active Comparator: Arm B
    Ipilimumab and nivolumab

Primary Outcome Measure

Evaluation of efficacy of ipilimumab and nivolumab With or without UV1 vaccine in patients With inoperable malignant pleural mesothelioma progressing after first-line platinum-based chemotherapy. [ Time Frame: Monitoring for change in imaging evalated tumor lesions indicating progression throughout the trial until 5 years of follow-up has past. ]

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