Last reviewed · How we verify
NCT03972046
Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma
Phase 2 trial testing Talimogene laherparepvec (T-Vec) in Melanoma (Skin). Withdrawn.
3 February 2020
Quick facts
| Lead sponsor | TriHealth Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 24 June 2019 |
| Primary completion | 3 February 2020 |
| Estimated completion | 3 February 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Talimogene laherparepvec (T-Vec) — full drug profile →
- Dabrafenib (BRAF Inhibitor) — full drug profile →
- Trametinib (MEK Inhibitor) — full drug profile →
Conditions studied
- Melanoma (Skin) — all drugs for Melanoma (Skin) →
- Melanoma Stage IIIb-IVM1a — all drugs for Melanoma Stage IIIb-IVM1a →
- Metastasis Skin — all drugs for Metastasis Skin →
- Tumor Skin — all drugs for Tumor Skin →
Sponsor
TriHealth Inc. — full company profile →
Who can join
18 and older, any sex, with Melanoma (Skin) or Melanoma Stage IIIb-IVM1a. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intratumoral Immunotherapy for Early-stage Solid Tumors.
Hong WX, Haebe S, Lee AS, Westphalen CB, et al · · 2020 · cited 138× · PMID 32071116 · DOI 10.1158/1078-0432.ccr-19-3642 -
Oncolytic Herpes Simplex Virus-Based Therapies for Cancer.
Aldrak N, Alsaab S, Algethami A, Bhere D, et al · · 2021 · cited 61× · PMID 34207386 · DOI 10.3390/cells10061541 -
BRAF Inhibitor Resistance in Melanoma: Mechanisms and Alternative Therapeutic Strategies.
Zhong J, Yan W, Wang C, Liu W, et al · · 2022 · cited 47× · PMID 36181568 · DOI 10.1007/s11864-022-01006-7 -
Adaptive ERK signalling activation in response to therapy and in silico prognostic evaluation of EGFR-MAPK in HNSCC.
Rong C, Muller MF, Xiang F, Jensen A, et al · · 2020 · cited 31× · PMID 32424150 · DOI 10.1038/s41416-020-0892-9 -
Herpes simplex virus 1 as an oncolytic viral therapy for refractory cancers.
Scanlan H, Coffman Z, Bettencourt J, Shipley T, et al · · 2022 · cited 24× · PMID 35965554 · DOI 10.3389/fonc.2022.940019 -
Oncolytic HSV and cancer drug interactions: Current clinical status and future directions.
Vázquez-Arreguín K, Rivera-Caraballo KA, Ventarapragada D, Chiocca EA, et al · · 2025 · cited 6× · PMID 40702727 · DOI 10.1016/j.ymthe.2025.07.034 -
Injectable Therapies for Regional Melanoma.
Farrow NE, Leddy M, Landa K, Beasley GM. · · 2020 · cited 4× · PMID 32482318 · DOI 10.1016/j.soc.2020.02.008 -
Intratumoral immunotherapy prior to cancer surgery, a promising therapeutic approach.
Silihe Kamga K, Fiering S. · · 2025 · PMID 40607406 · DOI 10.3389/fimmu.2025.1545000
Verify or expand the search:
- PubMed search for NCT03972046
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Melanoma (Skin)
Currently open trials in the same condition.
- NCT06643286 — Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma · NA · recruiting
- NCT06298734 — High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial · NA · recruiting
- NCT05704647 — Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases · Phase 2 · recruiting
- NCT05492682 — START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer · Phase 1 · active not recruiting
- NCT05649683 — Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors · NA · recruiting
Other TriHealth Inc. trials
Trials by the same sponsor.
- NCT07017920 — Vitamin D and Hypertensive Disorders of Pregnancy · NA · not yet recruiting
- NCT06843538 — Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery · Phase 3 · recruiting
- NCT06958003 — Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime · NA · enrolling by invitation
- NCT06957990 — Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics · NA · enrolling by invitation
- NCT06414083 — Histologic Comparison of Ablative Techniques for Endometriosis · NA · recruiting
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 NCT03972046 (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 TriHealth Inc.
- Last refreshed: 19 October 2020
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/NCT03972046.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing