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

NCT04300244 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-02-29

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BIOLOGICAL

UV1 vaccine + leukine

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.

BIOLOGICAL

ipilimumab

The responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.

BIOLOGICAL

nivolumab

The responses to ipilimumab and nivolumab combination therapy seen in MPM is encouraging.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Ultimovacs ASA

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Åslaug Helland

    lead OTHER

Principal Investigators

  • Åslaug Helland, Prof, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-04
Primary Completion
2025-03-15
Completion
2027-03-15

Countries

  • Australia
  • Denmark
  • Norway
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300244 on ClinicalTrials.gov