Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

Phase 2 Active not recruiting 216 enrolled UNICANCER Fondation ARC · collab Hoffmann-La Roche · collab National Cancer Institute, France · collab

NaSingle-groupOpen-labelTreatment

Summary

Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment. To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.

Timeline

Start: 2014-10-13
Primary completion: 2019-05-07
Completion: 2027-10-13

Outcome

Mixed primary results

paper The ORR had a 99.9% probability of being ≥30%. PMID 31959346 ↗

paper In the BRAFnonV600 cohort, no objective response was observed and this cohort was stopped. PMID 31959346 ↗

Publications

Mazieres J, Cropet C, Montane L, Barlesi F, Souquet PJ, Quantin X, Dubos-Arvis C, Otto J, Favier L, Avrillon V, Cadranel J, Moro-Sibilot D, Monnet I, Westeel V, Le Treut J, Brain E, Tredaniel J, Jaffro M, Collot S, Ferretti GR, Tiffon C, Mahier-Ait Oukhatar C, Blay JY. Vemurafenib in non-small-cell lung cancer patients with BRAFV600 and BRAFnonV600 mutations. Ann Oncol. 2020 Feb;31(2):289-294. doi: 10.1016/j.annonc.2019.10.022. Epub 2020 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vemurafenib	Small molecule	960 mg	Oral