Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02967692
Registration number
NCT02967692
Ethics application status
Date submitted
16/11/2016
Date registered
18/11/2016
Titles & IDs
Public title
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Query!
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Query!
Secondary ID [1]
0
0
2016-002794-35
Query!
Secondary ID [2]
0
0
CPDR001F2301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
COMBI-i
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Melanoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Spartalizumab
Other interventions - Placebo
Treatment: Drugs - Dabrafenib
Treatment: Drugs - Trametinib
Experimental: Part 1: Safety run-in Cohort - In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
Experimental: Part 2: Biomarker cohort - In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
Experimental: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib - In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Placebo comparator: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib - In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Treatment: Other: Spartalizumab
Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks
Other interventions: Placebo
Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks
Treatment: Drugs: Dabrafenib
Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.
Treatment: Drugs: Trametinib
Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Other interventions
Query!
Intervention code [3]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
Query!
Assessment method [1]
0
0
DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs
Query!
Timepoint [1]
0
0
Up to 8 weeks (Part 1)
Query!
Primary outcome [2]
0
0
Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
Query!
Assessment method [2]
0
0
Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
Query!
Timepoint [2]
0
0
Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
Query!
Primary outcome [3]
0
0
Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
Query!
Assessment method [3]
0
0
Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
Query!
Timepoint [3]
0
0
Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
Query!
Primary outcome [4]
0
0
Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1
Query!
Assessment method [4]
0
0
Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
Query!
Timepoint [4]
0
0
Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Overall survival is defined as the time from date of randomization to date of death due to any cause
Query!
Timepoint [1]
0
0
Up to death due to any cause, assessed up to approximately 5 years
Query!
Secondary outcome [2]
0
0
Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1
Query!
Assessment method [2]
0
0
ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
Query!
Timepoint [2]
0
0
Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1
Query!
Assessment method [3]
0
0
DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
Query!
Timepoint [3]
0
0
From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)
Query!
Secondary outcome [4]
0
0
Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1
Query!
Assessment method [4]
0
0
DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Query!
Timepoint [4]
0
0
Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year
Query!
Secondary outcome [5]
0
0
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores
Query!
Assessment method [5]
0
0
The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale.
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.
The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.
Query!
Timepoint [5]
0
0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Query!
Secondary outcome [6]
0
0
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores
Query!
Assessment method [6]
0
0
The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning.
The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.
Query!
Timepoint [6]
0
0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Query!
Secondary outcome [7]
0
0
Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores
Query!
Assessment method [7]
0
0
The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain.
The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.
Query!
Timepoint [7]
0
0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Query!
Secondary outcome [8]
0
0
Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status
Query!
Assessment method [8]
0
0
The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.
The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.
Query!
Timepoint [8]
0
0
From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)
Query!
Secondary outcome [9]
0
0
Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score
Query!
Assessment method [9]
0
0
The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma.
The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma.
The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.
Query!
Timepoint [9]
0
0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Query!
Secondary outcome [10]
0
0
Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Query!
Assessment method [10]
0
0
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.
Query!
Timepoint [10]
0
0
From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
Query!
Secondary outcome [11]
0
0
Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression
Query!
Assessment method [11]
0
0
PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having = 1% expression and a negative status was defined as having \< 1% expression.
Query!
Timepoint [11]
0
0
Up to disease progression or death due to any cause, up to 2.8 years (Part 3)
Query!
Secondary outcome [12]
0
0
Randomized (Part 3): OS by PD-L1 Expression
Query!
Assessment method [12]
0
0
OS is defined as the time from date of randomization to date of death due to any cause.
OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having = 1% expression and a negative status is defined as having \< 1% expression.
Query!
Timepoint [12]
0
0
Up to death due to any cause, up to 5 years
Query!
Secondary outcome [13]
0
0
Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline
Query!
Assessment method [13]
0
0
Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.
Query!
Timepoint [13]
0
0
Baseline
Query!
Secondary outcome [14]
0
0
Spartalizumab ADA Incidence
Query!
Assessment method [14]
0
0
Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
Query!
Timepoint [14]
0
0
Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).
Query!
Secondary outcome [15]
0
0
Trough Concentration (Ctrough) for Spartalizumab
Query!
Assessment method [15]
0
0
Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.
Query!
Timepoint [15]
0
0
Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
Query!
Secondary outcome [16]
0
0
Pre-dose Plasma Concentration for Dabrafenib
Query!
Assessment method [16]
0
0
Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.
Query!
Timepoint [16]
0
0
Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
Query!
Secondary outcome [17]
0
0
Pre-dose Plasma Concentration for Trametinib
Query!
Assessment method [17]
0
0
Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.
Query!
Timepoint [17]
0
0
Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
Query!
Secondary outcome [18]
0
0
Number of Participants With Dose Interruptions
Query!
Assessment method [18]
0
0
Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib
Query!
Timepoint [18]
0
0
From baseline to end of treatment, up to 5 years
Query!
Secondary outcome [19]
0
0
Number of Participants With Dose Reductions
Query!
Assessment method [19]
0
0
Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib
Query!
Timepoint [19]
0
0
From baseline to end of treatment, up to 5 years
Query!
Secondary outcome [20]
0
0
Relative Dose Intensity
Query!
Assessment method [20]
0
0
Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio of dose intensity and planned dose intensity
Query!
Timepoint [20]
0
0
From baseline to end of treatment, up to 5 years
Query!
Eligibility
Key inclusion criteria
Inclusion criteria Part 1: Safety run-in
* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
* Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
* Measurable disease according to RECIST 1.1
* ECOG performance status = 1
Part 2: Biomarker cohort
* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
* At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
* Measurable disease according to RECIST 1.1
* ECOG performance status = 2
Part 3: Double-blind, randomized, placebo-controlled part
* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
* ECOG performance status = 2
* Measurable disease according to RECIST 1.1
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Part 1: Safety run-in
* Subjects with uveal or mucosal melanoma
* Any history of CNS metastases
* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen
* Radiation therapy within 4 weeks prior to start of study treatment
* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
* Subjects with uveal or mucosal melanoma
* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment
* Radiation therapy within 4 weeks prior to start of study treatment
* Clinically active cerebral melanoma metastasis.
* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
Other protocol-defined Inclusion/Exclusion may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/02/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
26/08/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
569
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Gateshead
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - North Sydney
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Greenslopes
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Prahran
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2290 - Gateshead
Query!
Recruitment postcode(s) [2]
0
0
2060 - North Sydney
Query!
Recruitment postcode(s) [3]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [4]
0
0
3181 - Prahran
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Kansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Nebraska
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Pennsylvania
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Tennessee
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Utah
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Buenos Aires
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Santa Fe
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Tyrol
Query!
Country [13]
0
0
Austria
Query!
State/province [13]
0
0
Graz
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Linz
Query!
Country [15]
0
0
Austria
Query!
State/province [15]
0
0
Salzburg
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
St Poelten
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Brussel
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Bruxelles
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
PR
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
RS
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
SP
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Rio de Janeiro
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Plovdiv
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Sofia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
British Columbia
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Ontario
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Quebec
Query!
Country [28]
0
0
Chile
Query!
State/province [28]
0
0
Araucania
Query!
Country [29]
0
0
Chile
Query!
State/province [29]
0
0
Santiago
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Czech Republic
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
CZE
Query!
Country [32]
0
0
Czechia
Query!
State/province [32]
0
0
Poruba
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Brno
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Praha 10
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
Praha
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Aarhus
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Cedex 09
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Haute Vienne
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Amiens
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Besancon Cedex
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Bobigny Cedex
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Bordeaux Cedex
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Boulogne Billancourt
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Caen
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Clermont Ferrand
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Dijon
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Grenoble
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Lille
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Lorient
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Lyon
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Marseille
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Mulhouse cedex
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Nice
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Paris 10
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Pierre Benite
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Poitiers
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Reims
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Rouen
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Strasbourg Cedex
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Toulouse
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Vandoeuvre-les-Nancy
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Villejuif
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Baden Wuerttemberg
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Bavaria
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Berlin
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Bonn
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Chemnitz
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Dresden
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Duesseldorf
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Erfurt
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Essen
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Freiburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Gera
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Halle Saale
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Hamburg
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Hannover
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Heidelberg
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Homburg
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Kiel
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Leipzig
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Mainz
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Marburg
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Minden
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Muenchen
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Muenster
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Stade
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Tuebingen
Query!
Country [88]
0
0
Greece
Query!
State/province [88]
0
0
Athens
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Budapest
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Debrecen
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Szeged
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Haifa
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Jerusalem
Query!
Country [94]
0
0
Israel
Query!
State/province [94]
0
0
Ramat Gan
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
BA
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
BG
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
BO
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
BS
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
FC
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
GE
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
MB
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
MI
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
MO
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
PD
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
RM
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
SI
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
TO
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
VR
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Napoli
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Fukuoka
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Kyoto
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Osaka
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Tokyo
Query!
Country [114]
0
0
Mexico
Query!
State/province [114]
0
0
Distrito Federal
Query!
Country [115]
0
0
Mexico
Query!
State/province [115]
0
0
Guanajuato
Query!
Country [116]
0
0
Mexico
Query!
State/province [116]
0
0
Jalisco
Query!
Country [117]
0
0
Netherlands
Query!
State/province [117]
0
0
Zuid Holland
Query!
Country [118]
0
0
Netherlands
Query!
State/province [118]
0
0
Breda
Query!
Country [119]
0
0
Norway
Query!
State/province [119]
0
0
Oslo
Query!
Country [120]
0
0
Poland
Query!
State/province [120]
0
0
Gdansk
Query!
Country [121]
0
0
Poland
Query!
State/province [121]
0
0
Warszawa
Query!
Country [122]
0
0
Portugal
Query!
State/province [122]
0
0
Lisboa
Query!
Country [123]
0
0
Portugal
Query!
State/province [123]
0
0
Porto
Query!
Country [124]
0
0
Russian Federation
Query!
State/province [124]
0
0
Chelyabinsk
Query!
Country [125]
0
0
Russian Federation
Query!
State/province [125]
0
0
Moscow
Query!
Country [126]
0
0
Russian Federation
Query!
State/province [126]
0
0
Nizhny Novgorod
Query!
Country [127]
0
0
Russian Federation
Query!
State/province [127]
0
0
Omsk
Query!
Country [128]
0
0
Russian Federation
Query!
State/province [128]
0
0
Saint Petersburg
Query!
Country [129]
0
0
Russian Federation
Query!
State/province [129]
0
0
Samara
Query!
Country [130]
0
0
Russian Federation
Query!
State/province [130]
0
0
St Petersburg
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Andalucia
Query!
Country [132]
0
0
Spain
Query!
State/province [132]
0
0
Asturias
Query!
Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Cadiz
Query!
Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Catalunya
Query!
Country [135]
0
0
Spain
Query!
State/province [135]
0
0
Comunidad Valenciana
Query!
Country [136]
0
0
Spain
Query!
State/province [136]
0
0
Galicia
Query!
Country [137]
0
0
Spain
Query!
State/province [137]
0
0
Las Palmas de Gran Canaria
Query!
Country [138]
0
0
Spain
Query!
State/province [138]
0
0
Madrid
Query!
Country [139]
0
0
Sweden
Query!
State/province [139]
0
0
Goteborg
Query!
Country [140]
0
0
Sweden
Query!
State/province [140]
0
0
Lund
Query!
Country [141]
0
0
Sweden
Query!
State/province [141]
0
0
Stockholm
Query!
Country [142]
0
0
Switzerland
Query!
State/province [142]
0
0
Aarau
Query!
Country [143]
0
0
Switzerland
Query!
State/province [143]
0
0
Zuerich
Query!
Country [144]
0
0
Thailand
Query!
State/province [144]
0
0
Hat Yai
Query!
Country [145]
0
0
Thailand
Query!
State/province [145]
0
0
Bangkok
Query!
Country [146]
0
0
United Kingdom
Query!
State/province [146]
0
0
Cornwall
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
England
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Middlesex
Query!
Country [149]
0
0
United Kingdom
Query!
State/province [149]
0
0
Surrey
Query!
Country [150]
0
0
United Kingdom
Query!
State/province [150]
0
0
Leicester
Query!
Country [151]
0
0
United Kingdom
Query!
State/province [151]
0
0
London
Query!
Country [152]
0
0
United Kingdom
Query!
State/province [152]
0
0
Manchester
Query!
Country [153]
0
0
United Kingdom
Query!
State/province [153]
0
0
Middlesbrough
Query!
Country [154]
0
0
United Kingdom
Query!
State/province [154]
0
0
Preston
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma
Query!
Trial website
https://clinicaltrials.gov/study/NCT02967692
Query!
Trial related presentations / publications
Tawbi HA, Robert C, Brase JC, Gusenleitner D, Gasal E, Garrett J, Savchenko A, Gorgun G, Flaherty KT, Ribas A, Dummer R, Schadendorf D, Long GV, Nathan PD, Ascierto PA. Spartalizumab or placebo in combination with dabrafenib and trametinib in patients with BRAF V600-mutant melanoma: exploratory biomarker analyses from a randomized phase 3 trial (COMBI-i). J Immunother Cancer. 2022 Jun;10(6):e004226. doi: 10.1136/jitc-2021-004226. Dummer R, Long GV, Robert C, Tawbi HA, Flaherty KT, Ascierto PA, Nathan PD, Rutkowski P, Leonov O, Dutriaux C, Mandala M, Lorigan P, Ferrucci PF, Grob JJ, Meyer N, Gogas H, Stroyakovskiy D, Arance A, Brase JC, Green S, Haas T, Masood A, Gasal E, Ribas A, Schadendorf D. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma. J Clin Oncol. 2022 May 1;40(13):1428-1438. doi: 10.1200/JCO.21.01601. Epub 2022 Jan 14. Dummer R, Lebbe C, Atkinson V, Mandala M, Nathan PD, Arance A, Richtig E, Yamazaki N, Robert C, Schadendorf D, Tawbi HA, Ascierto PA, Ribas A, Flaherty KT, Pakhle N, Campbell CD, Gusenleitner D, Masood A, Brase JC, Gasal E, Long GV. Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i. Nat Med. 2020 Oct;26(10):1557-1563. doi: 10.1038/s41591-020-1082-2. Epub 2020 Oct 5.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/92/NCT02967692/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT02967692/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02967692