Drugs / UV1
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03538314 | Jul 2018 → Oct 2022 | melanoma | Ultimovacs ASA | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02275416 | Feb 2015 → Oct 2016 | melanoma | Ultimovacs ASA | Completed | No outcome recorded |
| Phase 1/2 | NCT01784913 | Apr 2013 → Jul 2015 | prostate cancer | Ultimovacs ASA | Completed | No outcome recorded |
| Phase 1/2 | NCT01789099 | Apr 2013 → Feb 2016 | non-small cell lung carcinoma | Ultimovacs ASA | Completed | No outcome recorded |
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT05344209 | Aug 2022 → Jul 2025 overdue | non-small cell lung carcinoma | Vestre Viken Hospital Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT04742075 | Dec 2021 → May 2026 overdue | ovarian cancer | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05075122 | Aug 2021 → Aug 2024 | head and neck squamous cell carcinoma | Martin-Luther-University Halle-Wittenberg | Unknown | Missed primary |
| Phase 2 | NCT04382664 | May 2020 → Jan 2024 | melanoma | Ultimovacs ASA | Completed | Missed primary |
| Phase 2 | NCT04300244 | May 2020 → Mar 2025 overdue | lung cancer, malignant pleural mesothelioma | Åslaug Helland | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-09-08 | Zelluna Immunotherapy AS | Results Ultimovacs Announces Updated Data Analysis on UV1 Phase II NIPU Trial in Mesothelioma at ESMO 2024 zelluna.com ↗
In addition, the ESMO 2024 data presentation demonstrates a positive difference in overall survival (OS) for UV1 treatment at the latest patient follow-up, although the degree of benefit is less than previously reported. |
| 2024-03-07 | Zelluna Immunotherapy AS | Results Ultimovacs Announces Topline Results from INITIUM Study Evaluating UV1 Vaccination Added to Ipilimumab and Nivolumab in Patients with Unresectable or Metastatic Malignant Melanoma zelluna.com ↗
With the 18-month minimum follow-up of the patients in the INITIUM trial, the trial did not meet the primary endpoint of prolonging progression-free survival (PFS). |
| 2024-03-02 | Zelluna Immunotherapy AS | Results Ultimovacs announces publication of results from NIPU Phase II trial with UV1 vaccination in mesothelioma in European Journal of Cancer zelluna.com ↗
Analyses on the secondary endpoints, objective response rate (ORR) by BICR and overall survival (OS), showed a significant benefit of adding the UV1 vaccine to ipilimumab and nivolumab. |
| 2023-10-23 | Zelluna Immunotherapy AS | Results Ultimovacs Provides Complete Phase II NIPU Results Presented at ESMO 2023: Significant and Clinically Meaningful Improvement in Overall Survival for Patients with Malignant Mesothelioma Receiving UV1 Cancer Vaccine zelluna.com ↗
UV1, in combination with the checkpoint inhibitors ipilimumab and nivolumab from Bristol-Myers Squibb, met the study protocol’s predefined threshold for statistical significance and demonstrated a clinically meaningful overall survival benefit with no added toxicities, compared to ipilimumab and nivolumab alone |
| 2023-10-17 | Zelluna Immunotherapy AS | Results Ultimovacs Announces NIPU Results Presented at ESMO 2023: Significant and Clinically Meaningful Improvement in Overall Survival for Patients Receiving UV1 Cancer Vaccine in Phase II NIPU Trial in Malignant Mesothelioma zelluna.com ↗
UV1, in combination with the checkpoint inhibitors ipilimumab and nivolumab from Bristol-Myers Squibb, demonstrated a clinically meaningful overall survival benefit with no added toxicities, compared to ipilimumab and nivolumab alone, in the second-line treatment of patients with malignant mesothelioma |
| 2022-09-12 | Zelluna Immunotherapy AS | Results Ultimovacs Announces Publication of Phase I Melanoma Trial Data in Journal of Translational Medicine zelluna.com ↗
Vaccine-induced immune responses were apparent in 91% of evaluable patients, with strong T cell proliferation demonstrated in peripheral blood, and vaccine-related T cell receptor clones detected in blood and in tumor biopsy. |
| 2021-11-09 | Zelluna Immunotherapy AS | Results Ultimovacs’ SITC2021 Data Shows Enduring T cell Response for UV1 Combination in Melanoma zelluna.com ↗
They show that the drug combination induces a T cell immune response in 91% of patients, and that the response can persist as long as 5 years (the end of the study period). |
| 2021-05-19 | Zelluna Immunotherapy AS | Results Ultimovacs’ UV1 in combination with pembrolizumab shows 60% Objective Response Rate in advanced melanoma Phase I data zelluna.com ↗
Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today announced that its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab, demonstrated a 60% objective response rate (ORR) in metastatic malignant melanoma. |
All press releases naming this drug 8 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | UV1 | “UV1” NCT02275416 ↗ |
| Known as | UV1 vaccine | “The UV1 vaccine and GM-CSF will be given before and between treatments of ipilimumab.” NCT02275416 ↗ |
| Modality | Peptide | “UV1 (a therapeutic synthetic peptide vaccine)” NCT01784913 ↗ |
| Route | Other | “UV1 peptide vaccine with escalating concentrations (100, 300 and 700 microgram) will be injected intradermally at the same injection in the lower abdomen.” NCT01784913 ↗ |
| Target | TERT | “The mode of action of UV1 is to activate the immune system to induce T cells directed against telomerase (hTERT).” NCT04300244 ↗ |