Abstract | BACKGROUND:
Malignant pleural mesothelioma (MPM) is a rare and aggressive tumour. For patients with inoperable disease, few treatment options are available after first line chemotherapy. The combination of ipilimumab and nivolumab has recently shown increased survival compared to standard chemotherapy, but most patients do not respond and improvements are called for. Telomerase is expressed in mesothelioma cells, but only sparsely in normal tissues and is therefore an attractive target for therapeutic vaccination. Vaccination against telomerase is tolerable and has shown to induce immune responses associated with increased survival in other cancer types. There is a well-founded scientific rationale for the combination of a telomerase vaccine and checkpoint inhibition to improve treatment response in MPM patients. METHODS: DISCUSSION: Checkpoint inhibition is used for treatment of mesothelioma, but many patients still do not respond. Increasing therapy response to immunotherapy is an important goal. Possible approaches include combination with chemotherapy, radiotherapy, targeted therapy and other immunotherapeutic agents. Predictive biomarkers are necessary to ensure optimal treatment for each patient and to prevent unnecessary side effects. This trial seeks to improve treatment response by combining checkpoint inhibition with a telomerase vaccine and also to explore mechanisms for treatment response and resistance. Knowledge gained in the NIPU study may be transferred to the first line setting and to other cancers with limited benefit from immunotherapy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04300244, registered March 8th, 2020, https://clinicaltrials.gov/ct2/show/NCT04300244?term=NIPU&draw=2&rank=1 .
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Authors | Vilde Drageset Haakensen, Anna K Nowak, Espen Basmo Ellingsen, Saima Jamil Farooqi, Maria Moksnes Bjaanæs, Henrik Horndalsveen, Tine Mcculloch, Oscar Grundberg, Susana M Cedres, Åslaug Helland |
Journal | Journal of translational medicine
(J Transl Med)
Vol. 19
Issue 1
Pg. 232
(05 31 2021)
ISSN: 1479-5876 [Electronic] England |
PMID | 34059094
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Antineoplastic Combined Chemotherapy Protocols
- Humans
- Ipilimumab
(therapeutic use)
- Mesothelioma
(drug therapy)
- Mesothelioma, Malignant
- Nivolumab
(therapeutic use)
- Vaccination
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