Three ongoing trials

Prostate cancer (EudraCT No. 2012-002411-26)

Newly diagnosed, androgen sensitive, metastatic PCa
UV1 treatment concomitant with anti-androgen therapy.

Patient inclusion is completed.

Objectives

Primary objectives
Assessment of safety and tolerability of UV1 and immunological response

Secondary objectives
Selection of biological dose of peptides for further clinical trials

Exploratory objectives
Assessment of anti-tumor activity. Assessment of biomarkers

Design

Phase I/IIa, Open label, dose escalation. 3 dosage groups with 7 patients, total 21 patients

 

 

Non small cell lung cancer (EudraCT No. 2012-001852-20)

Stage IIIb – IV disease.

Patient inclusion is completed.

Objectives

Primary objectives
Assessment of safety and tolerability of UV1 and immunological response

Secondary objectives
Selection of biological dose of peptides for further clinical trials

Exploratory objectives
Assessment of anti-tumor activity. Assessment of biomarkers

DESIGN

Phase I/IIa, Open label, dose escalation. 3 dosage groups with 7 patients, total 21 patients

 

 

Melanoma – UV1 in combination with ipilimumab

EudraCT number: 2013-005582-39

Inclusion of 20 patients planned

OBJECTIVES

Primary objectives
Document the safety and tolerability profile for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma

Secondary objectives
Assessment of anti-tumor activity. Assessment of biomarkers

Document treatment response (objective response rate, progression free survival) for the ipilimumab/UV1 combination

Exploratory objectives
Explore potential biomarkers for efficacy and safety of the ipilimumab/UV1 combination

DESIGN

Phase I/IIa, Open label, total 20 patients.

 

Rationale for the Ultimovacs UV1 / ipilimumab combination trial

The checkpoint inhibitor ipilimumab specifically binds to CTLA4 which is up-regulated in T cells following activation. The role of CTLA4 is to limit the expansion of activated T-cell clones. This mechanism limits not only spontaneous, but also vaccine induced immune responses. It is now realized that the CD4 positive T helper-cells may be the main target for CTLA4 inhibition moving the focus for regulation (the checkpoint) to the Th-cell, which itself is the regulator of CTL expansion.

The rationale for the combination study is thus to combine a mainly Th activating vaccine (UV1) with a mainly Th targeting antibody (ipilimumab) to investigate the safety of such a combination and the impact on immune responses and clinical responses.