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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03207867




Registration number
NCT03207867
Ethics application status
Date submitted
19/06/2017
Date registered
5/07/2017

Titles & IDs
Public title
A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma
Scientific title
A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma
Secondary ID [1] 0 0
2017-000241-49
Secondary ID [2] 0 0
CNIR178X2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC, Non Small Cell Lung Cancer 0 0
RCC, Renal Cell Cancer 0 0
Pancreatic Cancer 0 0
Urothelial Cancer 0 0
Head and Neck Cancer 0 0
DLBCL, Diffused Large B Cell Lymphoma 0 0
MSS, Microsatellite Stable Colon Cancer 0 0
TNBC, Triple Negative Breast Cancer 0 0
Melanoma 0 0
mCRPC, Metastatic Castration Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NIR178
Treatment: Drugs - PDR001

Experimental: NIR178 + PDR001 - Part 1: NIR178 continuously in combination with PDR001 400mg every 4 weeks. The part 1 enrolled 9 different tumor types.

Experimental: NIR178 BID Intermittent + PDR001 - Part 2: Three different dosing schedules of NIR178 twice daily (BID) including continuous and two intermittent in combination with PDR001

Experimental: Part 3 - Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). A film-coated tablet of NIR178 was assessed.

Experimental: Japanese safety run-in part - Different dosing schedules of NIR178 were explored.


Treatment: Drugs: NIR178
NIR178, a new, non-xanthine based compound, is a potent oral adenosine A2a receptor against antagonist being developed by Novartis.

NIR178 was administered orally twice daily (BID) as a capsule (Part 1, Part 2 and Japanese safety run-in) and as a film-coated table (Part 3). There were up to 3 dose levels assessed: 80, 160 and 240 mg. Three alternative dosing schedules were evaluated: continuous (Part 1, Part 2, Part 3, Japanese safety run-in), 2 weeks on/2 weeks off (Part 2) and 1 week on/1 week off (Part 2).

Each cycle consisted of 28 days.

Treatment: Drugs: PDR001
PDR001 is a human monoclonal antibody (MAb) administered on Day 1 of each cycle. PDR001 400 mg was administered via intravenous (i.v.) infusion over 30 minutes every 4 weeks (Q4W).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
Timepoint [1] 0 0
Up to 3.9 years
Primary outcome [2] 0 0
Part 1: Overall Response Rate (ORR) Per Cheson 2014 for DLBCL
Timepoint [2] 0 0
Up to 2.5 years
Primary outcome [3] 0 0
Part 2: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
Timepoint [3] 0 0
Up to 4.7 years
Primary outcome [4] 0 0
Part 3: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
Timepoint [4] 0 0
Up to 0.5 years
Secondary outcome [1] 0 0
Part 1: Overall Response Rate (ORR) Per iRECIST for Solid Tumors
Timepoint [1] 0 0
Up to 3.9 years
Secondary outcome [2] 0 0
Part 2: Overall Response Rate (ORR) Per iRECIST for Solid Tumors
Timepoint [2] 0 0
Up to 4.7 years
Secondary outcome [3] 0 0
Part 3: Overall Response Rate (ORR) Per iRECIST for Solid Tumors
Timepoint [3] 0 0
Up to 0.5 years
Secondary outcome [4] 0 0
Part 1: Mean Percentage Change in PSA From Baseline
Timepoint [4] 0 0
Baseline, up to 0.8 years
Secondary outcome [5] 0 0
Part 1: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors
Timepoint [5] 0 0
Up to 3.9 years
Secondary outcome [6] 0 0
Part 1: Disease Control Rate (DCR) Per iRECIST for Solid Tumors
Timepoint [6] 0 0
Up to 3.9 years
Secondary outcome [7] 0 0
Part 1: Disease Control Rate (DCR) Per Cheson 2014 for DLBCL
Timepoint [7] 0 0
Up to 2.5 years
Secondary outcome [8] 0 0
Part 2: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors
Timepoint [8] 0 0
Up to 4.7 years
Secondary outcome [9] 0 0
Part 2: Disease Control Rate (DCR) Per iRECIST for Solid Tumors
Timepoint [9] 0 0
Up to 4.7 years
Secondary outcome [10] 0 0
Part 3: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors
Timepoint [10] 0 0
Up to 0.5 years
Secondary outcome [11] 0 0
Part 3: Disease Control Rate (DCR) Per iRECIST for Solid Tumors
Timepoint [11] 0 0
Up to 0.5 years
Secondary outcome [12] 0 0
Part 1: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors
Timepoint [12] 0 0
Up to 3.9 years
Secondary outcome [13] 0 0
Part 1: Duration Of Response (DOR) Per iRECIST for Solid Tumors
Timepoint [13] 0 0
Up to 3.9 years
Secondary outcome [14] 0 0
Part 1: Duration Of Response (DOR) Per Cheson 2014 for DLBCL
Timepoint [14] 0 0
Up to 2.5 years
Secondary outcome [15] 0 0
Part 2: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors
Timepoint [15] 0 0
Up to 4.7 years
Secondary outcome [16] 0 0
Part 2: Duration Of Response (DOR) Per iRECIST for Solid Tumors
Timepoint [16] 0 0
Up to 4.7 years
Secondary outcome [17] 0 0
Part 3: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors
Timepoint [17] 0 0
Up to 0.5 years
Secondary outcome [18] 0 0
Part 3: Duration Of Response (DOR) Per iRECIST for Solid Tumors
Timepoint [18] 0 0
Up to 0.5 years
Secondary outcome [19] 0 0
Part 1: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors
Timepoint [19] 0 0
Up to 3.9 years
Secondary outcome [20] 0 0
Part 1: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors
Timepoint [20] 0 0
Up to 3.9 years
Secondary outcome [21] 0 0
Part 1: Progression-Free Survival (PFS) Per Cheson 2014 for DLBCL
Timepoint [21] 0 0
Up to 2.5 years
Secondary outcome [22] 0 0
Part 2: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors
Timepoint [22] 0 0
Up to 4.7 years
Secondary outcome [23] 0 0
Part 2: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors
Timepoint [23] 0 0
Up to 4.7 years
Secondary outcome [24] 0 0
Part 3: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors
Timepoint [24] 0 0
Up to 0.5 years
Secondary outcome [25] 0 0
Part 3: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors
Timepoint [25] 0 0
Up to 0.5 years
Secondary outcome [26] 0 0
Part 1: 2-year Overall Survival (OS)
Timepoint [26] 0 0
2 years
Secondary outcome [27] 0 0
Part 2: 2-year Overall Survival (OS)
Timepoint [27] 0 0
2 years
Secondary outcome [28] 0 0
Part 3: 2-year Overall Survival (OS)
Timepoint [28] 0 0
2 years
Secondary outcome [29] 0 0
Part 1: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue
Timepoint [29] 0 0
Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.
Secondary outcome [30] 0 0
Part 2: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue
Timepoint [30] 0 0
Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.
Secondary outcome [31] 0 0
Part 3: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue
Timepoint [31] 0 0
Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.
Secondary outcome [32] 0 0
Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Timepoint [32] 0 0
Up to 4 years (Part 1), 4.8 years (Part 2) and 0.6 years (Part 3)
Secondary outcome [33] 0 0
Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of NIR178
Timepoint [33] 0 0
Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)
Secondary outcome [34] 0 0
Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of PDR001
Timepoint [34] 0 0
Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)
Secondary outcome [35] 0 0
Part 1, 2 and 3: Dose Intensity of NIR178
Timepoint [35] 0 0
Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)
Secondary outcome [36] 0 0
Part 1, 2 and 3: Dose Intensity of PDR001
Timepoint [36] 0 0
Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)
Secondary outcome [37] 0 0
Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies
Timepoint [37] 0 0
Up to approximately 5 years
Secondary outcome [38] 0 0
Japan Safety Run-in: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timepoint [38] 0 0
28 days
Secondary outcome [39] 0 0
Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
Timepoint [39] 0 0
Up to 0.7 years
Secondary outcome [40] 0 0
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178
Timepoint [40] 0 0
Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days
Secondary outcome [41] 0 0
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178
Timepoint [41] 0 0
Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days
Secondary outcome [42] 0 0
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178
Timepoint [42] 0 0
Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days
Secondary outcome [43] 0 0
All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)
Timepoint [43] 0 0
Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days
Secondary outcome [44] 0 0
All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)
Timepoint [44] 0 0
Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days
Secondary outcome [45] 0 0
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)
Timepoint [45] 0 0
Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days
Secondary outcome [46] 0 0
All Study Parts: Maximum Observed Serum Concentration (Cmax) of PDR001
Timepoint [46] 0 0
First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days
Secondary outcome [47] 0 0
All Study Parts: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Timepoint [47] 0 0
First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days
Secondary outcome [48] 0 0
All Study Parts: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001
Timepoint [48] 0 0
First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days

Eligibility
Key inclusion criteria
* Male or female patients =18 years of age. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
* Histologically documented advanced or metastatic solid tumors or lymphomas Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL), microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC), melanoma, metastatic castration resistant prostate cancer (mCRPC) Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology Part 3: histologically confirmed diagnosis of selected advanced/metastatic malignancies. Part 3 will be opened to further assess TNBC patients with a PD-L1 SP-142 IC score of 0 (<1%). A second tumor group will be considered for Part 3 after completion of Part 1.
* Patient (except for those participating in Japanese safety run-in) must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study.
* Safety run-in part in Japanese patients can enroll any tumor type included in part 1, 2 and 3.

The collection of recent sample is permitted under the following conditions (both must be met):

Biopsy was collected = 6 months before 1st dose of study treatment and available at the site.

No immunotherapy was given to the patient since collection of biopsy.

- Part 1 - 3 only: Patients (other than those with DLBCL) must previously have received at least 1 and no more than 3 prior lines of therapy for their disease (with the exception of IO-pretreated cutaneous melanoma, HNSCC and RCC), unless considered inappropriate for the patient (e.g. safety concern, label contraindication): Patients with NSCLC must have received a prior platinum-based combination. Patients with EGFR positive NSCLC with a T790M mutation must have progressed on osimertinib or discontinued due to toxicity.

Patients with head and neck cancer must have received a prior platinum-containing regimen.

Patients with bladder cancer must have received a prior platinum-containing regimen or be ineligible for cisplatin.

Patients with renal cell carcinoma must have received a prior VEGF tyrosine kinase inhibitor (TKI).

Patients with MSS colorectal cancer must have received (or be intolerant to) prior therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens.

Patients with triple negative breast cancer:. Part 1: must have received a prior taxane-containing regimen Part 3: should have received no more than 2 prior lines of therapy including taxane-based chemotherapy and should have a known PD-L1 status as per local available testing as determined by VENTANA PD-L1 SP142 Assay with IC score of 0 (<1%) Patients with DLBCL should be limited to those with no available therapies of proven clinical benefit Patients should have had prior autologous hematopoietic stem cell transplantation (auto-HSCT) or determined to be ineligible for auto-HSCT.

Patients with melanoma:

BRAF V600E wild type patients: must have received anti-PD-1/PD-L1 single agent, or in combination with anti-CTLA-4 therapy BRAF V600E mutant patients: must have received prior anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4 therapy. In addition, subjects must have received prior BRAF V600E inhibitor therapy, either single-agent or in combination with a MEK inhibitor

Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC):

* Of the 1-3 prior lines of therapy, patients must have received and failed at least one line of treatment after emergence of castration resistant disease
* Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors; single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except for NSCLC patients enrolled in part 3 and Japanese safety run-in part.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI), or calipers by clinical exam.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g. Parkinson's disease) may be considered for enrollment on a case by case basis.
* Current or prior use of immunosuppressive medication within 28 days before the first dose of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of prednisone)
* History of another primary malignancy except for:

Malignancy treated with curative intent and with no known active disease =2 years before the first dose of study drug and of low potential risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease

* Active or prior documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
* More than 3 prior lines of therapy except for Japanese safety run-in part.
* History of interstitial lung disease or non-infectious pneumonitis
* Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 6 weeks is indicated as washout period. For patients receiving anticancer immunotherapies, 4 weeks is indicated as the washout period. GnRH therapy to maintain effective testosterone suppression levels is allowed for mCRPC patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/02/2023
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Blacktown
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Austria
State/province [7] 0 0
Salzburg
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
Czechia
State/province [9] 0 0
Czech Republic
Country [10] 0 0
France
State/province [10] 0 0
Marseille
Country [11] 0 0
Germany
State/province [11] 0 0
Essen
Country [12] 0 0
Germany
State/province [12] 0 0
Koeln
Country [13] 0 0
Italy
State/province [13] 0 0
MI
Country [14] 0 0
Italy
State/province [14] 0 0
Napoli
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
Spain
State/province [18] 0 0
Catalunya
Country [19] 0 0
Switzerland
State/province [19] 0 0
St. Gallen
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03207867