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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

May 4, 2020

Primary Completion Date

March 15, 2025

Study Completion Date

March 15, 2027

Conditions
CancerCancer, LungCancer of LungMesotheliomaMesothelioma; LungMesothelioma; PleuraMesotheliomas 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.

Trial Locations (7)

Unknown

University of Western Australia, Perth

Aalborg University Hospital, Aalborg

Copenhagen University Hospital, Copenhagen

Oslo University Hospital, Oslo

Vall d'Hebron institute of oncology, Barcelona

University Hospital of Skåne, Lund

Karolinska, Stockholm

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Oslo University Hospital

OTHER

collaborator

Ultimovacs ASA

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Åslaug Helland

OTHER

NCT04300244 - Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma | Biotech Hunter | Biotech Hunter