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Clinical Trials/EUCTR2013-001546-34-AT
EUCTR2013-001546-34-ATActive, not recruitingPhase 1

eoadjuvant treatment with the combination of vemurafenib and cobimetinib (GDC-0973) in limited metastasis of malignant melanoma (AJCC stage IIIC/IV) and integrated biomarker study: a single armed phase II EADO trial - NEO-VC

niversity Hospital Tübingen0 sites110 target enrollmentStarted: November 6, 2014Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
110
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1.Adult patients, = 18 years of age
  • •2.Willing and able to give informed consent
  • •3.Metastatic melanoma, stage IIIC or IV (American Joint Committee on Cancer 2010)
  • •4.ECOG 0-1
  • •5.MAP-kinase pathway inhibitor treatment-naïve
  • •6.Positive for BRAF V600 mutation, preferentially to be shown from metastatic tumor tissue
  • •7.Decision of eligibility for neoadjuvant combined vemurafenib and cobimetinib treatment by interdisci-plinary tumor board. Patient with limited numbers of metastases and few organ systems involved should be selected, making surgical resection after neoad-juvant treatment probable.
  • •8.Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST V1.1) criteria
  • •9.Adequate hematologic and organ function as defined by:
  • •ANC = 1.5 × 109/L
  • •Platelets = 100 × 109/L
  • •Hemoglobin = 9 g/dL
  • •Albumin = 2.5 g/dL
  • •Bilirubin = 1.5 × the upper limit of normal (ULN)
  • •AST, ALT, and alkaline phosphatase = 3 × ULN,
  • •except patients with documented liver metasta-ses:
  • •AST and/or ALT = 5 × ULN
  • •Patients with documented liver or bone metasta-ses: alkaline phosphatase = 5 × ULN
  • •Serum creatinine = 1.5 × ULN
  • •10.For fertile men: effective contraception during treat-ment and for 6 months after completion in such a manner that the risk of pregnancy is minimized
  • •11.For women of childbearing potential, negative preg-nancy test performed within 28 days prior study en-rolment, preferably as close to the first dose as pos-sible, and agrees to use adequate contraception from pregnancy test onwards, through the dosing period, and for at least 6 months after the last dose of investigational product as:
  • •complete abstinence from sexual intercourse
  • •oral contraceptive, either combined or progesto-gen alone
  • •injectable progestogen
  • •implants of levonorgestrel
  • •estrogenic vaginal ring
  • •percutaneous contraceptive patches
  • •intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
  • •male partner sterilization (vasectomy with docu-mentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
  • •double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 55
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 55
  • •1.Adult patients, = 18 years of age
  • •2.Willing and able to give informed consent
  • •3.Metastatic melanoma, stage IIIC or IV (American Joint Committee on Cancer 2010)
  • •4.ECOG 0-1
  • •5.MAP-kinase pathway inhibitor treatment-naïve
  • •6.Positive for BRAF V600 mutation, preferentially to be shown from metastatic tumor tissue
  • •7.Decision of eligibility for neoadjuvant combined vemurafenib and cobimetinib treatment by interdisci-plinary tumor board. Patient with limited numbers of metastases and few organ systems involved should be selected, making surgical resection after neoad-juvant treatment probable.
  • •8.Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST V1.1) criteria
  • •9.Adequate hematologic and organ function as defined by:
  • •ANC = 1.5 × 109/L
  • •Platelets = 100 × 109/L
  • •Hemoglobin = 9 g/dL
  • •Albumin = 2.5 g/dL
  • •Bilirubin = 1.5 × the upper limit of normal (ULN)
  • +58 more not shown

Exclusion Criteria

  • •1.Candidates for direct surgery: patients with single site easily resectable metastasis
  • •2.Major surgical procedure or significant traumatic injury within 2 weeks prior to first dose of study drug treatment
  • •3.Active central nervous system metastases ex-cept metastases after complete resection or ste-reotactic irradiation and stable status for at least 3 months
  • •4.History of carcinomatous meningitis
  • •5.Severe cardiovascular disease within 6 months prior to study drug administration
  • •6.History or evidence of cardiovascular risk includ-ing any of the following
  • •LVEF < 50% or < LLN, whichever is lower
  • •a QTc interval = 450 ms
  • •evidence of clinically significant uncontrolled arrhythmias
  • •7.History or evidence of retinal vein occlusion
  • •8.Previous malignancy within 5 years prior to study, except for basal or squamous cell carci-noma of the skin, melanoma in-situ, or carcino-ma in-situ of the cervix
  • •9.Psychological, familial, sociological, or geograph-ical conditions that do not permit compliance with the protocol
  • •10.Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • •11.Legal incapacity or limited legal capacity
  • •12.Subjects housed in an institution on official or le-gal orders
  • •13.Participation in another clinical study with exper-imental therapy within the 30 days before start of treatment
  • •14.Pregnancy or lactation period
  • •15.Concomitant use of study therapy and drugs with a potential for QT prolongation (see database www.qtdrugs.org)
  • •16.Known immediate or delayed hypersensitivity re-action or idiosyncrasy to cobimetinib and/or vemurafenib and/or to any of its excipients
  • •17.Patients with diseases that affect liver function, such as viral hepatitis
  • •18.Patients receiving medications known to increase the risk of peripheral edema
  • •1.Candidates for direct surgery: patients with single site easily resectable metastasis
  • •2.Major surgical procedure or significant traumatic injury within 2 weeks prior to first dose of study drug treatment
  • •3.Active central nervous system metastases ex-cept metastases after complete resection or ste-reotactic irradiation and stable status for at least 3 months
  • •4.History of carcinomatous meningitis
  • •5.Severe cardiovascular disease within 6 months prior to study drug administration
  • •6.History or evidence of cardiovascular risk includ-ing any of the following
  • •LVEF < 50% or < LLN, whichever is lower
  • •a QTc interval = 450 ms
  • •evidence of clinically significant uncontrolled arrhythmias
  • •7.History or evidence of retinal vein occlusion
  • •8.Previous malignancy within 5 years prior to study, except for basal or squamous cell carci-noma of the skin, melanoma in-situ, or carcino-ma in-situ of the cervix
  • •9.Psychological, familial, sociological, or geograph-ical conditions that do not permit compliance with the protocol
  • •10.Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • •11.Legal incapacity or limited legal capacity
  • •12.Subjects housed in an institution on official or le-gal orders
  • •13.Participation in another clinical study with exper-imental therapy within the 30 days before start of treatment
  • •14.Pregnancy or lactation period
  • •15.Concomitant use of study therapy and drugs with a potential for QT prolongation (see database www.qtdrugs.org)
  • •16.Known immediate or delayed hypersensitivity re-action or idiosyncrasy to cobimetinib and/or vemurafenib and/or to any of its excipients
  • •17.Patients with diseases that affect liver function, such as viral hepatitis
  • •18.Patients receiving medications known to increase the risk of peripheral edema
  • •1.Candidates for direct surgery: patients with single site easily resectable metastasis
  • •2.Major surgical procedure or significant traumatic injury within 2 weeks prior to first dose of study drug treatment
  • •3.Active central nervous system metastases ex-cept metastases after complete resection or ste-reotactic irradiation and stable status for at least 3 months
  • •4.History of carcinomatous meningitis
  • •5.Severe cardiovascular disease within 6 months prior to study drug administration
  • •6.History or evidence of cardiovascular risk includ-ing any of the following
  • •LVEF < 50% or < LLN, whichever is lower
  • •a QTc interval = 450 ms
  • +13 more not shown

Investigators

Sponsor
niversity Hospital Tübingen

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