Malignant MelanomaPhase 3COMBI-APlusNCT03551626
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
A Phase 3 study testing Dabrafenib and Trametinib in people with Malignant Melanoma, run by Novartis Pharmaceuticals at 100 sites in 23 countries.
Trial summary
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Dabrafenib and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 100 sitesin 23 countries
- Study dates
- 29 Aug 2018to 16 Sep 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completely resected histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)] no more than 12 weeks, from last surgery, before Day 1
- Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma were eligible.
- Subjects who had previously had Stage III melanoma at any time were not eligible.
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
- V600E/K mutation positive using a validated local test
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Who cannot join
- Uveal or mucosal melanoma
- Evidence of metastatic disease including unresectable in-transit metastasis
- Received any prior adjuvant or neoadjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
- Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and had not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ
- History or current evidence of cardiovascular risk
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
Trial locations and contacts
100 sites in 23 countries.
100 sites in 23 countries
France20 sites
Novartis Investigative Site
Besançon, 25030
Novartis Investigative Site
Bobigny, 93009
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Boulogne-Billancourt, 92104
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Dijon, 21034
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Lorient, 56322
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75475
Novartis Investigative Site
Pierre-Bénite, Cedex 02, 69495
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rennes, Ille Et Vilaine, 35062
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Villejuif, 94800
Italy14 sites
Novartis Investigative Site
Antella - Bagno A Ripoli, FI, 50011
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Meldola, FC, 47014
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Padova, PD, 35100
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Roma, RM, 00128
Novartis Investigative Site
Roma, RM, 00167
Novartis Investigative Site
Torino, TO, 10126
Novartis Investigative Site
Udine, UD, 33100
Canada9 sites
Novartis Investigative Site
Calgary, Alberta, T2N 4N2
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
London, Ontario, N6A 4L6
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Québec, Quebec, G1R 2J6
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, M5G 1Z6
Czechia8 sites
Novartis Investigative Site
Brno, Czech Republic, 656 53
Novartis Investigative Site
Hradec Králové, CZE, 500 05
Novartis Investigative Site
Olomouc, 779 00
Novartis Investigative Site
Ostrava, Poruba, 708 52
Novartis Investigative Site
Prague, Czech Republic, 180 00
Novartis Investigative Site
Prague, Prague 1, 11000
Novartis Investigative Site
Prague, 12808
Novartis Investigative Site
Zlín, Czech Republic, 762 75
United Kingdom7 sites
Novartis Investigative Site
Bristol, Avon, BS2 8ED
Novartis Investigative Site
Cambridge, CB2 2QQ
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
Manchester, M20 4BX
Novartis Investigative Site
Northwood, Middlesex, HA6 2RN
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
Novartis Investigative Site
Southampton, SO16 6YD
Greece4 sites
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Athens, 18547
Novartis Investigative Site
Athens, GR 115 22
Novartis Investigative Site
Thessaloniki, 54622
Russia4 sites
Novartis Investigative Site
Moscow, 115478
Novartis Investigative Site
Moscow Region Istra Village, 143423
Novartis Investigative Site
Omsk, 644013
Novartis Investigative Site
Saint Petersburg, 197758
Sweden4 sites
Novartis Investigative Site
Gothenburg, SE-413 45
Novartis Investigative Site
Örebro, 701 85
Novartis Investigative Site
Stockholm, SE 171 76
Novartis Investigative Site
Umeå, SE 901 85
Argentina3 sites
Novartis Investigative Site
Buenos Aires, C1125ABE
Novartis Investigative Site
Córdoba, X5004BAL
Novartis Investigative Site
Rosario, Sante Fe, S200KZE
Brazil3 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-003
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20220410
Novartis Investigative Site
São Paulo, São Paulo, 01246 000
Finland3 sites
Novartis Investigative Site
Helsinki, 9
Novartis Investigative Site
Tampere, FIN-33521
Novartis Investigative Site
Turku, 20520
Hungary3 sites
Novartis Investigative Site
Budapest, H 1122
Novartis Investigative Site
Pécs, 7623
Novartis Investigative Site
Szeged, H 6725
Poland3 sites
Novartis Investigative Site
Gdansk, 80 952
Novartis Investigative Site
Warsaw, 02 781
Novartis Investigative Site
Wroclaw, 53 413
Australia2 sites
Novartis Investigative Site
Cairns, QLD 4870
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Israel2 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Ramat Gan, 52621
Japan2 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045
Novartis Investigative Site
Sapporo, Hokkaido, 060-8543
Norway2 sites
Novartis Investigative Site
Ålesund, NO-6026
Novartis Investigative Site
Oslo, 0379
Slovakia2 sites
Novartis Investigative Site
Bratislava, 812 50
Novartis Investigative Site
Košice, 04191
About this study
Official title: COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
Read the detailed description
This was an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk cutaneous melanoma were screened for eligibility.
This study consisted of two periods:
- Treatment Period - patients received up to 12 months of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily). In the adapted pyrexia management algorithm, dabrafenib and trametinib were interrupted promptly at the onset of pyrexia (≥38°C) and were restarted upon the improvement of symptoms at the same dose if patients remained symptom free (temperature <38°C) for at least 24 hours. In addition, dabrafenib and trametinib could be interrupted in the presence of pyrexia syndrome (i.e. chills, rigours, night sweats, or influenza-like symptoms) without documented temperature ≥38°C for cases of suspected recurrent pyrexia, at the investigators' discretion.
- Follow-up Period - patients were followed for disease relapse through 24 months from first dose date. Moreover, patients were followed for overall survival through withdrawal, lost to follow-up, death, or the end of study, whichever occurs first. The follow-up period started once treatment was completed or treatment was prematurely discontinued.
- Conditions
- Malignant Melanoma
- Being tested
- Dabrafenib, Trametinib
- Keywords
- dabrafenib, trametinib, adjuvant, Stage III melanoma, combination treatment, pyrexia
- Medical subject headings
- Melanoma, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Also called DRB436
Supplied as dabrafenib 50 mg and 75 mg capsules for oral administration
TrametinibDrug
Also called TMT212
Supplied as trametinib 0.5mg, and 2.0mg tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib and trametinib combination therapy | Experimental | Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months. Receives: Drug: Dabrafenib; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Rate of Pyrexia Related Events
The composite rate of pyrexia related events was calculated as the total number of participants experiencing at least one of the three components of the composite endpoint (i.e., grade 3/4 pyrexia, hospitalization due to pyrexia, or permanent treatment discontinuation due to pyrexia), divided by the total number of participants treated in the study and multiplied by 100. Pyrexia is defined as fever ≥ 38 °C.
Pyrexia events were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening) and Grade 5 (Death)
Measured: Baseline up to 12 months
Secondary outcomes (5)
Relapse Free Survival (RFS) Rate
RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first. Treatment emergent malignancies other than second melanomas were not considered as events.
RFS rate is the estimated percent probability that a patient will remain event-free up to the specified time point. RFS rate was obtained from the Kaplan-Meier survival estimates. RFS was censored if no RFS event was observed before the first to occur between: (i) the analysis cut-off date, and (ii) the date when a new anti-cancer therapy is started. The censoring date was the date of the last adequate tumor assessment prior to data cut-off date/start of new anti-cancer therapy date.
Measured: At 12 and 24 months
Overall Survival (OS) Rate
OS is defined as the time from date of the first dose of study medication to date of death due to any cause, whichever comes first. If a patient was not known to have died, then OS rate is the estimated probability that a patient will remain event-free up to the specified time point. OS rate was obtained from the Kaplan-Meier survival estimates. OS was censored at the last contact date when the patient was known to be alive (on or before the cut-off date).
Measured: At 12 and 24 months
Percentage of Participants Who Required Management of Pyrexia
Percentage of patients who experienced pyrexia and required intervention including hospitalizations, concomitant medications, and study treatment modifications (dose reductions, permanent discontinuations and/or interruptions) due to pyrexia. Pyrexia is defined as fever ≥ 38 °C
Measured: Baseline up to 12 months
Percentage of Participants Who Permanently Discontinued Treatment Due to Any Adverse Event (AE)
Percentage of participants who permanently discontinued treatment due to any AE during treatment. An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign, symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study.
Measured: Baseline up to 12 months
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS)
The FACT-M is a questionnaire that assesses participant health-related quality of life. It includes a melanoma specific (FACT-M MS) subscale that consists in 16 items related to signs, symptoms, physical/social activities most relevant to participants with advanced-stage melanoma. Each item ranges from 0 (not at all) to 4 (very much). FACT-M MS score ranges from 0 to 64, with higher score indicating better quality of life. If a patient discontinued the study treatment at Month 1 or Month 2, then the follow-up assessments started at Month 3 follow-up and continued until Month 24 follow-up or at withdrawal, lost to follow-up, death, or end of study. If a patient discontinued the study treatment from Month 3 through Month 5, the follow-up assessments started at Month 6 follow-up. If a patient discontinued from Month 6 through Month 11, the follow-up assessments started from Month 12 follow-up. For patients who completed treatment, the follow-up assessments started from Month 15 follow-up
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start29 Aug 2018
- Primary completion5 Oct 2020
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551626
- Sponsor's protocol ID
- CDRB436F2410
- Other IDs
- 2018-000168-27, 2018
- Acronym
- COMBI-APlus
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2018
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Atkinson V, Robert C, Grob JJ, Gogas H, Dutriaux C, Demidov L, Gupta A, Menzies AM, Ryll B, Miranda F, Banerjee H, Lau M, Del Vecchio M. Improved pyrexia-related outcomes associated with an adapted pyrexia adverse event management algorithm in patients treated with adjuvant dabrafenib plus trametinib: Primary results of COMBI-APlus. Eur J Cancer. 2022 Mar;163:79-87. doi: 10.1016/j.ejca.2021.12.015. Epub 2022 Jan 14.
PubMed 35042070
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)
- ClinicalTrials.gov ID
- NCT03551626
- Acronym / sponsor ID
- COMBI-APlus / CDRB436F2410
- Conditions
- Malignant Melanoma
- Keywords
- dabrafenib, trametinib, adjuvant, Stage III melanoma, combination treatment, pyrexia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
Detailed description
This was an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk cutaneous melanoma were screened for eligibility.
This study consisted of two periods:
- Treatment Period - patients received up to 12 months of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily). In the adapted pyrexia management algorithm, dabrafenib and trametinib were interrupted promptly at the onset of pyrexia (≥38°C) and were restarted upon the improvement of symptoms at the same dose if patients remained symptom free (temperature <38°C) for at least 24 hours. In addition, dabrafenib and trametinib could be interrupted in the presence of pyrexia syndrome (i.e. chills, rigours, night sweats, or influenza-like symptoms) without documented temperature ≥38°C for cases of suspected recurrent pyrexia, at the investigators' discretion.
- Follow-up Period - patients were followed for disease relapse through 24 months from first dose date. Moreover, patients were followed for overall survival through withdrawal, lost to follow-up, death, or the end of study, whichever occurs first. The follow-up period started once treatment was completed or treatment was prematurely discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib and trametinib combination therapy | Experimental | Drug: Dabrafenib, Drug: TrametinibSubjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completely resected histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)] no more than 12 weeks, from last surgery, before Day 1
- V600E/K mutation positive using a validated local test
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Key exclusion criteria (6 listed)
- Uveal or mucosal melanoma
- Evidence of metastatic disease including unresectable in-transit metastasis
- Received any prior adjuvant or neoadjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
- Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and had not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ
- History or current evidence of cardiovascular risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabrafenibAlso: DRB436Supplied as dabrafenib 50 mg and 75 mg capsules for oral administration | Drug | Dabrafenib and trametinib combination therapy |
| TrametinibAlso: TMT212Supplied as trametinib 0.5mg, and 2.0mg tablets for oral administration | Drug | Dabrafenib and trametinib combination therapy |
Primary outcome
Composite Rate of Pyrexia Related Events
Time frame: Baseline up to 12 months
The composite rate of pyrexia related events was calculated as the total number of participants experiencing at least one of the three components of the composite endpoint (i.e., grade 3/4 pyrexia, hospitalization due to pyrexia, or permanent treatment discontinuation due to pyrexia), divided by the total number of participants treated in the study and multiplied by 100. Pyrexia is defined as fever ≥ 38 °C. Pyrexia events were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening) and Grade 5 (Death)
5 secondary outcomes
Relapse Free Survival (RFS) Rate
Time frame: At 12 and 24 months
Overall Survival (OS) Rate
Time frame: At 12 and 24 months
Percentage of Participants Who Required Management of Pyrexia
Time frame: Baseline up to 12 months
Percentage of Participants Who Permanently Discontinued Treatment Due to Any Adverse Event (AE)
Time frame: Baseline up to 12 months
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS)
Time frame: Baseline up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35042070Atkinson V, Robert C, Grob JJ, Gogas H, Dutriaux C, Demidov L, Gupta A, Menzies AM, Ryll B, Miranda F, Banerjee H, Lau M, Del Vecchio M. Improved pyrexia-related outcomes associated with an adapted pyrexia adverse event management algorithm in patients treated with adjuvant dabrafenib plus trametinib: Primary results of COMBI-APlus. Eur J Cancer. 2022 Mar;163:79-87. doi: 10.1016/j.ejca.2021.12.015. Epub 2022 Jan 14.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
100 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dabrafenib and Trametinib in people with Malignant Melanoma, run by Novartis Pharmaceuticals at 100 sites in 23 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 6 inclusion and 6 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in France, Italy, Canada, Czechia, United Kingdom and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Rate of Pyrexia Related Events (time frame: Baseline up to 12 months). 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 NCT03551626, which also lists 1 linked publication.
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 29 Apr 2025.