NCT04163094: OLIVIA

Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy

Terminated Phase 1 Last updated 29 June 2023

What this trial tests

Phase 1 trial testing W_ova1 Vaccine in Ovarian Cancer in 8 participants. Terminated before completion.

Timeline

25 November 2019

Primary endpoint
26 June 2023

26 June 2023

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	25 November 2019
Primary completion	26 June 2023
Estimated completion	26 June 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• W_ova1 Vaccine — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

University Medical Center Groningen

Who can join

Eligibility, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first-in-human, open label phase I study in ovarian cancer patients with primary disease eligible for standard-of-care treatment with neo-adjuvant chemotherapy, i.e. 3 cycles carboplatin/paclitaxel, interval surgery and 3 additional cycles carboplatin/paclitaxel. Eight doses of the W\_ova1 vaccine will be administered prior and in combination with the (neo-)adjuvant chemotherapy to induce an anti-tumor immune response. Systemic immune responses are determined using peripheral blood mononuclear cells collected before, during and after vaccinations. Intratumoral accumulation of T-cells recognizing vaccine-encoded TAAs will be determined before vaccination in a tumor biopsy and after the 3 cycles of chemotherapy and the 5th vaccination using tumor tissue derived from interval surgery. \[18F\]FB-IL2 PET-CT will be used for the non-invasive assessment of T-cell activation and correlated to immunohistochemistry tumor tissue data from pre-treatment biopsy and interval debulking surgery

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lipid nanoparticles for mRNA delivery.
   Hou X, Zaks T, Langer R, Dong Y. · · 2021 · cited 2524× · PMID 34394960 · DOI 10.1038/s41578-021-00358-0
2. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
   Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
3. Lipids and Lipid Derivatives for RNA Delivery.
   Zhang Y, Sun C, Wang C, Jankovic KE, et al · · 2021 · cited 423× · PMID 34279087 · DOI 10.1021/acs.chemrev.1c00244
4. Opportunities and Challenges in the Delivery of mRNA-based Vaccines.
   Wadhwa A, Aljabbari A, Lokras A, Foged C, et al · · 2020 · cited 410× · PMID 32013049 · DOI 10.3390/pharmaceutics12020102
5. Advances in COVID-19 mRNA vaccine development.
   Fang E, Liu X, Li M, Zhang Z, et al · · 2022 · cited 368× · PMID 35322018 · DOI 10.1038/s41392-022-00950-y
6. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment.
   Lorentzen CL, Haanen JB, Met Ö, Met Ö, et al · · 2022 · cited 362× · PMID 36174631 · DOI 10.1016/s1470-2045(22)00372-2
7. mRNA vaccine: a potential therapeutic strategy.
   Wang Y, Zhang Z, Luo J, Han X, et al · · 2021 · cited 286× · PMID 33593376 · DOI 10.1186/s12943-021-01311-z
8. mRNA therapeutics in cancer immunotherapy.
   Beck JD, Reidenbach D, Salomon N, Sahin U, et al · · 2021 · cited 266× · PMID 33858437 · DOI 10.1186/s12943-021-01348-0