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NCT03289962
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors
Phase 1 trial testing Autogene cevumeran in Melanoma in 272 participants. Completed in 1 July 2025.
1 July 2025
Quick facts
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 272 |
| Start date | 21 December 2017 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 26 locations across Netherlands, Belgium, Sweden, United Kingdom, Germany, Canada, United States, Spain |
Drugs / interventions tested
- Autogene cevumeran — full drug profile →
- Atezolizumab (atezolizumab) — full drug profile →
Conditions studied
- Melanoma — all drugs for Melanoma →
- Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
- Bladder Cancer — all drugs for Bladder Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Genentech, Inc. — full company profile →
Who can join
18 and older, any sex, with Melanoma or Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The tumour microenvironment in pancreatic cancer - clinical challenges and opportunities.
Ho WJ, Jaffee EM, Zheng L. · · 2020 · cited 963× · PMID 32398706 · DOI 10.1038/s41571-020-0363-5 -
Towards personalized, tumour-specific, therapeutic vaccines for cancer.
Hu Z, Ott PA, Wu CJ. · · 2018 · cited 772× · PMID 29226910 · DOI 10.1038/nri.2017.131 -
Delivering the Messenger: Advances in Technologies for Therapeutic mRNA Delivery.
Kowalski PS, Rudra A, Miao L, Anderson DG. · · 2019 · cited 749× · PMID 30846391 · DOI 10.1016/j.ymthe.2019.02.012 -
Neoantigens: promising targets for cancer therapy.
Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x -
Advances in the development of personalized neoantigen-based therapeutic cancer vaccines.
Blass E, Ott PA. · · 2021 · cited 700× · PMID 33473220 · DOI 10.1038/s41571-020-00460-2 -
A review of cancer immunotherapy: from the past, to the present, to the future.
Esfahani K, Roudaia L, Buhlaiga N, Del Rincon SV, et al · · 2020 · cited 652× · PMID 32368178 · DOI 10.3747/co.27.5223 -
mRNA vaccine for cancer immunotherapy.
Miao L, Zhang Y, Huang L. · · 2021 · cited 640× · PMID 33632261 · DOI 10.1186/s12943-021-01335-5 -
Turning cold tumors into hot tumors by improving T-cell infiltration.
Liu YT, Sun ZJ. · · 2021 · cited 560× · PMID 33859752 · DOI 10.7150/thno.58390
Verify or expand the search:
- PubMed search for NCT03289962
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Autogene cevumeran
Trials testing the same drug.
- NCT05968326 — A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX A · Phase 2 · recruiting
- NCT03815058 — A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus P · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03289962 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
- Last refreshed: 4 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03289962.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing