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NCT03190824
Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma
Phase 2 trial testing OBP-301 in Melanoma Stage III in 4 participants. Status unknown.
24 June 2021
Quick facts
| Lead sponsor | Syneos Health |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 22 December 2016 |
| Primary completion | 24 June 2021 |
| Estimated completion | 31 October 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- OBP-301 — full drug profile →
Conditions studied
- Melanoma Stage III — all drugs for Melanoma Stage III →
- Melanoma Stage Iv — all drugs for Melanoma Stage Iv →
Sponsor
Syneos Health — full company profile →
Who can join
18 and older, any sex, with Melanoma Stage III or Melanoma Stage Iv. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Open-label, single-arm, multi-center, Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP 301 in patients with unresectable/unresected metastatic melanoma. This proof of concept study will be undertaken in male and female patients with unresectable Stage III and IV melanoma. Patients with unresectable/unresected mucosal melanoma may be enrolled after consultation with the Medical Monitor.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Viral vector platforms within the gene therapy landscape.
Bulcha JT, Wang Y, Ma H, Tai PWL, et al · · 2021 · cited 899× · PMID 33558455 · DOI 10.1038/s41392-021-00487-6 -
Recent advances of oncolytic virus in cancer therapy.
Mondal M, Guo J, He P, Zhou D. · · 2020 · cited 154× · PMID 32078405 · DOI 10.1080/21645515.2020.1723363 -
Oncolytic Viruses: Newest Frontier for Cancer Immunotherapy.
Rahman MM, McFadden G. · · 2021 · cited 107× · PMID 34771615 · DOI 10.3390/cancers13215452 -
White paper on microbial anti-cancer therapy and prevention.
Forbes NS, Coffin RS, Deng L, Evgin L, et al · · 2018 · cited 106× · PMID 30081947 · DOI 10.1186/s40425-018-0381-3 -
Oncolytic viruses encoding bispecific T cell engagers: a blueprint for emerging immunovirotherapies.
Heidbuechel JPW, Engeland CE. · · 2021 · cited 80× · PMID 33863363 · DOI 10.1186/s13045-021-01075-5 -
Inflammation and cancer: paradoxical roles in tumorigenesis and implications in immunotherapies.
Liu X, Yin L, Shen S, Hou Y. · · 2023 · cited 75× · PMID 37013041 · DOI 10.1016/j.gendis.2021.09.006 -
Concepts in Oncolytic Adenovirus Therapy.
Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522 -
Designer Oncolytic Adenovirus: Coming of Age.
Baker AT, Aguirre-Hernández C, Halldén G, Parker AL. · · 2018 · cited 66× · PMID 29904022 · DOI 10.3390/cancers10060201
Verify or expand the search:
- PubMed search for NCT03190824
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of OBP-301
Trials testing the same drug.
- NCT04685499 — Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperabl · Phase 2 · terminated
- NCT03172819 — Special Combination of OBP-301 and Pembrolizumab · Phase 1 · completed
Other recruiting trials for Melanoma Stage III
Currently open trials in the same condition.
- NCT06204991 — To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma · Phase 1 · recruiting
- NCT06551064 — Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients · Phase 1 · active not recruiting
- NCT06508775 — Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies · NA · recruiting
- NCT05655312 — MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma · Phase 1, PHASE2 · recruiting
- NCT05652673 — Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial · NA · recruiting
Other Syneos Health trials
Trials by the same sponsor.
- NCT07497503 — A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants · Phase 1 · not yet recruiting
- NCT05805618 — Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects · EARLY_PHASE1 · unknown
- NCT06435039 — A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers · Phase 1 · terminated
- NCT06170827 — Study to Evaluate the AIO-001 in Healthy Participants · Phase 1 · completed
- NCT05896969 — Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol · Phase 1 · completed
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 NCT03190824 (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 Syneos Health
- Last refreshed: 16 April 2019
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/NCT03190824.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing