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NCT03026517
Phase I Trial of Phenformin With Patients With Combination BRAF Inhibitor/MEK Inhibitor in Patients With BRAFV600E/K-mutated Melanoma
Phase 1 trial testing Dabrafenib in Melanoma in 18 participants. Completed in 21 January 2025.
21 January 2025
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 January 2017 |
| Primary completion | 21 January 2025 |
| Estimated completion | 21 January 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Dabrafenib (dabrafenib) — full drug profile →
- Trametinib (trametinib) — full drug profile →
- Phenformin — full drug profile →
Conditions studied
- Melanoma — all drugs for Melanoma →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Disease-free survival
Time frame: 2 years
The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response.
Sponsor's own description
The purpose of this study is to test whether it is safe to give phenformin with the standard drug combination of one of 3 FDA-approved combinations of BRAF inhibitor + MEK inhibitor which are standard treatments for patients with metastatic melanoma whose melanoma has a mutation in a gene called BRAF.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The future of cancer immunotherapy: microenvironment-targeting combinations.
Murciano-Goroff YR, Warner AB, Wolchok JD. · · 2020 · cited 554× · PMID 32467593 · DOI 10.1038/s41422-020-0337-2 -
Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies.
Zappasodi R, Merghoub T, Wolchok JD. · · 2018 · cited 386× · PMID 29634946 · DOI 10.1016/j.ccell.2018.03.005 -
Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3 -
Why All the Fuss about Oxidative Phosphorylation (OXPHOS)?
Xu Y, Xue D, Bankhead A, Neamati N. · · 2020 · cited 127× · PMID 33103432 · DOI 10.1021/acs.jmedchem.0c01013 -
Exploiting Metabolic Vulnerabilities of Cancer with Precision and Accuracy.
Wolpaw AJ, Dang CV. · · 2018 · cited 121× · PMID 29229182 · DOI 10.1016/j.tcb.2017.11.006 -
Mitochondrial metabolism as a potential therapeutic target in myeloid leukaemia.
de Beauchamp L, Himonas E, Helgason GV. · · 2022 · cited 119× · PMID 34561557 · DOI 10.1038/s41375-021-01416-w -
Targeting Metabolism in Cancer Cells and the Tumour Microenvironment for Cancer Therapy.
Li J, Eu JQ, Kong LR, Wang L, et al · · 2020 · cited 99× · PMID 33092283 · DOI 10.3390/molecules25204831 -
Targeting STAT3 and oxidative phosphorylation in oncogene-addicted tumors.
Lee M, Hirpara JL, Eu JQ, Sethi G, et al · · 2019 · cited 96× · PMID 30594485 · DOI 10.1016/j.redox.2018.101073
Verify or expand the search:
- PubMed search for NCT03026517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
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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 NCT03026517 (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 Memorial Sloan Kettering Cancer Center
- Last refreshed: 21 January 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/NCT03026517.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing