An electronic copy of the thesis may be ordered from the faculty up to 2 days prior to the public defence. Inquiries regarding the thesis after the public defence must be addressed to the candidate.
Trial Lecture – time and place
See Trial Lecture.
Adjudication committee
- First opponent: Lecturer Lars Ny, Sahlgrenska University Hospital
- Second opponent: Professor Ingvild Vistad, University of Bergen
- Third member and chair of the evaluation committee: Adjunct Professor Knut Jørgen Labori, University of Oslo
Chair of the Defence
Professor Ludvig A. Munthe, Faculty of Medicine, University of Oslo
Principal Supervisor
Senior Consultant Jon Amund Kyte, Oslo University Hospital
Summary
Ipilimumab was the first therapy with evidenced survival benefits in patients with metastatic melanoma, also representing the first immune checkpoint inhibitor in the treatment of cancer. Yet the impact of ipilimumab in daily clinical practice was not established.
The aims of the thesis were to assess the efficacy, toxicity and health-related quality of life in a real-world population with metastatic melanoma treated with ipilimumab. Results were based on a prospective, national phase IV clinical trial. Further, the safety and feasibility of combining ipilimumab with a telomerase peptide vaccine was assessed in a phase I/IIa clinical trial.
Results from the phase IV trial showed a median overall survival of 12.1 months with 20% of patients alive at five years. An impaired performance status and an elevated level of lactate dehydrogenase and C-reactive protein were poor prognostic features.
High-grade toxicity associated with ipilimumab was experienced by 28% of patients, with skin-related events, diarrhoea, fatigue and infection being most commonly reported.
Patients experienced significant deteriorations in health-related quality of life during treatment. However, it could not be concluded whether this was due to ipilimumab or progressive disease. Impaired health-related quality of life was associated with a worse prognosis. Combining such indicators with biological markers, defined three distinctive prognostic groups.
Results from the phase I/IIa trial demonstrated that combining ipilimumab with a telomerase peptide vaccine was feasible. Toxicity was moderate, with mostly ipilimumab-associated events or vaccination site reactions. Clinical benefit was observed.
Overall, it was demonstrated that treatment with ipilimumab in a real-world setting yielded clinical results comparable to phase III trials. Integrating objective and subjective prognostic markers may aid in selecting patients for ipilimumab. Combining ipilimumab with a telomerase peptide vaccine was possible.
Additional information
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