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DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

Study acronym: DETERMINE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 15 to 16 Eligibility criteria shortened, about 110 words · Study description expanded, about 2 wordsv6 Show 2 more changesShow less
    • Eligibility criteria shortened, about 110 words
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 17 to 15 Eligibility criteria expanded, about 64 words · Secondary endpoints revised (11) · Study description expanded, about 2 wordsv5 Show 3 more changesShow less
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints revised (11)
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 4 of 17 sitesv4
  4. Study description revised Site details revised at 2 of 17 sites · Study title revisedv3 Show 2 more changesShow less
    • Site details revised at 2 of 17 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  5. Start date changed from estimate of Mar 2023 to Mar 1, 2023 Secondary endpoints: details revised at 2 of 11 entries · Site details revised at 2 of 17 sitesv2 Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised at 2 of 17 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cancer Research UK
15 trials monitored
See 2 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 6 more diseases
This clinical trial is looking at a combination of drugs called vemurafenib and cobimetinib. Vemurafenib is approved as standard of care for adult patients with unresectable or metastatic melanoma. Cobimetinib is approved as standard of care in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Cobimetinib and vemurafenib work in patients with these types of cancers which have certain changes in the cancer cells called BRAF V600 mutation-positive. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also BRAF V600 mutation-positive. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
Trial Details
NCT Number NCT05768178
Lead Sponsor Cancer Research UK
Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche
Conditions Haematological Malignancy, Melanoma, Thyroid Cancer, Papillary, Ovarian Neoplasms, Colorectal Neoplasms, Laryngeal Neoplasms, Carcinoma, Non-Small-Cell Lung, Glioma +4 more
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov