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Metastatic MelanomaPhase 2NCT02768207

A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

A Phase 2 study testing Cobimetinib and Vemurafenib in people with Metastatic Melanoma, run by Hoffmann-La Roche at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Cobimetinib and Vemurafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
14 sitesin 2 countries
Study dates
23 May 2016to 27 Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-screening phase:
  • Participants with histologically confirmed cutaneous melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer 7th edition
  • Documentation of BRAF V600 test result mutation-positive status on melanoma tumor tissue using a validated tissue test
  • Treatment Phase:
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Adequate hematologic and end organ function obtained within 14 days prior to first dose of study drug treatment
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  • Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
  • Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and treatment regimen and follow-up after treatment discontinuation schedule
  • Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy
  • Participants should be able to swallow tablets
  • Documentation of BRAF mutation positive status in melanoma tissue

Who cannot join

  • Treatment Phase:
  • History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment
  • Use of prior chemotherapy or immunotherapy (including treatment with an anti-programmed death 1, or anti- programmed death ligand 1 or anti-cytotoxic T-lymphocyte-associated protein 4 monoclonal antibody) within 4 weeks before first study drug administration
  • Palliative radiotherapy within 14 days prior to the first dose of study treatment
  • Evidence of retinal pathology on ophthalmologic examination
  • Systemic risk factors for retinal vein occlusion
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  • History of clinically significant cardiac dysfunction
  • Current severe, uncontrolled systemic disease
  • Pregnancy, lactating or breast feeding
  • Intake of St. John's wort or hyperforin (a potent cytochrome P450 3A4 [CYP3A4 enzyme inducer] and grapefruit juice (a potent CYP3A4 enzyme inhibitor) at least 7 days prior to initiation of and during the study treatment

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Belgium11 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Brussel

    Brussels, 1090

  • CHIREC Edith Cavell

    Brussels, 1180

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • Clinique Ste-Elisabeth

    Namur, 5000

  • AZ Delta (Campus Wilgenstraat)

    Roeselare, 8800

  • AZ Nikolaas (Sint Niklaas)

    Sint-Niklaas, 9100

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Poland3 sites

  • Klinika Onkologii Klinicznej CO-I Kraków

    Krakow

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

    Poznan, 60-780

  • Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: A Single Arm, Open Label, Phase II, Multicenter Study to Assess The Detection of The BRAF V600 Mutation on cfDNA From Plasma in Patients With Advanced Melanoma

This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib. The length of the study will be approximately 38 months.

Being tested
Cobimetinib, Vemurafenib
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CobimetinibDrug

    Also called GDC-0973, RO5514041, XL518

    Participants will receive cobimetinib 60 mg tablets (three 20 mg tablet) orally OD for 21 consecutive days (Days 1 to 21), followed by a 7 day break (Days 22 to 28); in each 28-day cycle of treatment phase until disease progression, consent withdrawal, or the development of unacceptable toxicity.

  • VemurafenibDrug

    Also called RO5185426

    Participants will receive vemurafenib 960 mg tablets (four 240 mg tablet) orally BID from Day 1 to Day 28 of each 28-day cycle of the treatment phase until disease progression, consent withdrawal, or the development of unacceptable toxicity.

Study groups in NCT02768207
Study groupRoleWhat they receive
Treatment Phase: Vemurafenib+CobimetinibExperimentalParticipants with BRAF V600 mutation will receive vemurafenib 960 milligrams (mg) tablets orally twice daily (BID) on Days 1 to 28 along with cobimetinib 60 mg tablets orally once daily (OD) for 21 consecutive days (Days 1 to 21) of each 28-day cycle until disease progression, consent withdrawal, or the development of unacceptable toxicity.
Receives: Drug: Cobimetinib; Drug: Vemurafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with BRAF V600 Mutation as Assessed Using the Idylla^TM Diagnostic Platform

    Measured: Days -56 to -1 (Pre-screening period)

  2. Concentration of BRAF V600 Mutation as Determined on Plasma cfDNA

    Measured: Days -56 to -1 (Pre-screening period)

  3. Number of Participants by BRAF Mutation Status

    Measured: Days -56 to -1 (Pre-screening period)

  4. Number of Participants with BRAF V600 Mutation as Assessed Using the Idylla^TM Diagnostic Platform in Participants With BRAF Wild-Type Based on a Prior Tissue Test Result

    Measured: Days -56 to -1 (Pre-screening period)

Secondary outcomes (5)

  1. Percentage of Participants with Objective Response as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Baseline up to disease progression or death whichever occurs first (up to 38 months)

  2. Progression-Free Survival (PFS)

    Measured: Baseline up to disease progression or death whichever occurs first (up to 38 months)

  3. Duration of Response as Assessed by Investigator According to RECIST v1.1

    Measured: Baseline up to disease progression or death whichever occurs first (Up to 38 months)

  4. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 Cycle 1 up to 4 weeks after end of treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to 38 months)

  5. Overall Survival

    Measured: Baseline up to death (up to 38 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study start23 May 2016
  3. Primary completion20 Dec 2017
  4. Study completion27 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768207
Sponsor's protocol ID
ML29741
Other IDs
2015-001731-20, 2015
Status last verified
Aug 2019
First submitted
9 May 2016
Last updated
28 Aug 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cobimetinib and Vemurafenib in people with Metastatic Melanoma, run by Hoffmann-La Roche at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Belgium, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with BRAF V600 Mutation as Assessed Using the Idylla^TM Diagnostic Platform (time frame: Days -56 to -1 (Pre-screening period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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