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NCT03514901
To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.
Phase 2 trial testing Experimental combination beyond Focal Progression in Melanoma Metastatic in 120 participants. Status unknown.
29 April 2023
Quick facts
| Lead sponsor | Intergruppo Melanoma Italiano |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 18 June 2018 |
| Primary completion | 29 April 2023 |
| Estimated completion | 29 April 2023 |
| Sites | 14 locations across Italy |
Drugs / interventions tested
- Experimental combination beyond Focal Progression
- Pembrolizumab or Nivolumab — full drug profile →
Conditions studied
- Melanoma Metastatic — all drugs for Melanoma Metastatic →
- BRAF V600 Mutation — all drugs for BRAF V600 Mutation →
Sponsor
Intergruppo Melanoma Italiano — full company profile →
Who can join
18 and older, any sex, with Melanoma Metastatic or BRAF V600 Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current State of Target Treatment in BRAF Mutated Melanoma.
Tanda ET, Vanni I, Boutros A, Andreotti V, et al · · 2020 · cited 73× · PMID 32760738 · DOI 10.3389/fmolb.2020.00154 -
Significance of BRAF Kinase Inhibitors for Melanoma Treatment: From Bench to Bedside.
Fujimura T, Fujisawa Y, Kambayashi Y, Aiba S. · · 2019 · cited 23× · PMID 31514399 · DOI 10.3390/cancers11091342 -
The Management of Oligoprogression in the Landscape of New Therapies for Metastatic Melanoma.
Guida M, Bartolomeo N, De Risi I, Fucci L, et al · · 2019 · cited 22× · PMID 31615127 · DOI 10.3390/cancers11101559 -
Decreased survival in patients treated by chemotherapy after targeted therapy compared to immunotherapy in metastatic melanoma.
Mangin MA, Boespflug A, Maucort Boulch D, Vacheron CH, et al · · 2021 · cited 8× · PMID 33932099 · DOI 10.1002/cam4.3760
Verify or expand the search:
- PubMed search for NCT03514901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Melanoma Metastatic
Currently open trials in the same condition.
- NCT06889610 — A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors. · Phase 2 · recruiting
- NCT06767306 — Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma · Phase 2 · recruiting
- NCT07050940 — Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma · NA · recruiting
- NCT06783270 — T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma · Phase 1 · recruiting
- NCT06784648 — Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metast · Phase 1, PHASE2 · active not 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 NCT03514901 (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 Intergruppo Melanoma Italiano
- Last refreshed: 2 December 2021
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/NCT03514901.
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