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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03179436




Registration number
NCT03179436
Ethics application status
Date submitted
31/05/2017
Date registered
7/06/2017

Titles & IDs
Public title
Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)
Scientific title
A Phase 1 / 2 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
MK-1308-001
Secondary ID [2] 0 0
1308-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Quavonlimab
Treatment: Other - Pembrolizumab
Treatment: Drugs - Pembrolizumab/Quavonlimab

Experimental: Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1 - On Cycle 1, Day 1 of the Dose Escalation Phase, advanced solid tumor participants receive a single monotherapy dose lead-in with quavonlimab at dose level 1 (DL1). On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL1 in combination with pembrolizumab (pembro) at pembrolizumab dose level 1 (PDL1) according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Experimental: Escalation: DL 2 Quavonlimab + Pembro: Cohort 2 - On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL2. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Experimental: Escalation: DL 3 Quavonlimab + Pembro: Cohort 3 - On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL3. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL3 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A - On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1, both according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B - On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL1 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C - On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and at DL2 quavonlimab according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D - On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with SCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL2 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E - On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Experimental: Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F - On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 in combination with pembrolizumab at pembrolizumab dose level 2 (PDL2). Both quavonlimab and pembrolizumab will be administered according to Schedule 2 for up to 24 months on study.

Experimental: Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G - On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 according to Schedule 2 for up to 24 months on study. Participants who demonstrate radiographically confirmed progressive disease in Arm G will be eligible to receive combination therapy with pembrolizumab (crossover).

Experimental: Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I - On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants with advanced/metastatic solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.

Experimental: Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm K - On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants in mainland China with advanced solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.


Treatment: Other: Quavonlimab
Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.

Treatment: Other: Pembrolizumab
Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).

Treatment: Drugs: Pembrolizumab/Quavonlimab
Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with a Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to 6 weeks
Primary outcome [2] 0 0
Number of participants with =1 adverse event (AE)
Timepoint [2] 0 0
Up to ~2.5 years
Primary outcome [3] 0 0
Number of participants discontinuing study treatment due to an AE
Timepoint [3] 0 0
Up to ~2 years
Primary outcome [4] 0 0
Efficacy Expansion: Number of participants with =1 AE
Timepoint [4] 0 0
Up to ~2.5 years
Primary outcome [5] 0 0
Efficacy Expansion: Number of participants discontinuing study treatment due to an AE
Timepoint [5] 0 0
Up to ~2 years
Primary outcome [6] 0 0
Coformulation: Number of participants with =1 DLT
Timepoint [6] 0 0
Up to 6 weeks
Primary outcome [7] 0 0
Coformulation: Number of participants with =1 AE
Timepoint [7] 0 0
Up to ~2.5 years
Primary outcome [8] 0 0
Coformulation: Number of participants discontinuing study treatment due to an AE
Timepoint [8] 0 0
Up to ~2 years
Primary outcome [9] 0 0
Efficacy Expansion: Objective Response Rate (ORR) as assessed by blinded independent central review (BICR) based on adjusted Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timepoint [9] 0 0
Up to ~4 years
Secondary outcome [1] 0 0
Area under the plasma concentration time curve (AUC) of pembrolizumab
Timepoint [1] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [2] 0 0
Maximum concentration (Cmax) of pembrolizumab
Timepoint [2] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [3] 0 0
Minimum concentration (Cmin) of pembrolizumab
Timepoint [3] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [4] 0 0
Number of participants with pembrolizumab anti-drug antibodies (ADAs)
Timepoint [4] 0 0
At designated timepoints (up to ~2 years)
Secondary outcome [5] 0 0
AUC of quavonlimab
Timepoint [5] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [6] 0 0
Cmax of quavonlimab
Timepoint [6] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [7] 0 0
Cmin of quavonlimab
Timepoint [7] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [8] 0 0
Number of participants with quavonlimab ADAs
Timepoint [8] 0 0
At designated timepoints (up to ~2 years)
Secondary outcome [9] 0 0
Chinese Cohort: AUC of pembrolizumab
Timepoint [9] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [10] 0 0
Chinese Cohort: Cmax of pembrolizumab
Timepoint [10] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [11] 0 0
Chinese Cohort: Cmin of pembrolizumab
Timepoint [11] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [12] 0 0
Chinese Cohort: Number of participants with pembrolizumab ADAs
Timepoint [12] 0 0
At designated timepoints (up to ~2 years)
Secondary outcome [13] 0 0
Chinese Cohort: AUC of quavonlimab
Timepoint [13] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [14] 0 0
Chinese Cohort: Cmax of quavonlimab
Timepoint [14] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [15] 0 0
Chinese Cohort: Cmin of quavonlimab
Timepoint [15] 0 0
At designated timepoints (up to ~6 months)
Secondary outcome [16] 0 0
Chinese Cohort: Number of participants with quavonlimab ADAs
Timepoint [16] 0 0
At designated timepoints (up to ~2 years)
Secondary outcome [17] 0 0
Dose Escalation, Dose Confirmation, Coformulation: ORR as assessed by investigator based on adjusted RECIST v1.1
Timepoint [17] 0 0
Up to ~4 years
Secondary outcome [18] 0 0
Efficacy Expansion: Duration of Response (DOR) as assessed by BICR based on adjusted RECIST v1.1
Timepoint [18] 0 0
Up to ~4 years

Eligibility
Key inclusion criteria
For Dose Escalation Phase:

* Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor (except NSCLC for Cohorts 2 and 3) by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit

For Dose Confirmation Phase NSCLC Arms (A, B, C, and E):

* Have newly diagnosed histologically or cytologically-confirmed stage IIIB/stage IV NSCLC. Epidermal growth factor receptor (EGFR)-and anaplastic lymphoma kinase (ALK) translocation-directed therapy is not indicated as primary therapy. Participant must not have received prior systemic treatment for advanced NSCLC or must have received previous neoadjuvant and adjuvant chemotherapies =6 months before dosing of study drug if prior systemic treatment was given for early stage disease

For Dose Confirmation Phase SCLC Arm (Arm D):

* Have histologically- or cytologically-confirmed metastatic (Stage III/IV) SCLC with progressive disease after =1 platinum-based chemotherapy regimen. Participants with platinum-sensitive disease are eligible
* Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology
* Have Eastern Cooperative Oncology Group (ECOG) Performance Scale status of 0 or 1
* A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
* Is not a woman of child bearing potential (WOCBP) OR
* Is a WOCBP and using a contraceptive method that is highly effective during the intervention period and for at least 120 days after the last dose of pembrolizumab or pembrolizumab/quavonlimab, whichever comes last
* Female participants of childbearing potential must have negative urine or serum pregnancy test within 24 hours for urine and within 72 hours for serum prior to receiving the first dose of study treatment
* Male participants with a female partner(s) of child-bearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication and refrain from donating sperm during this period
* Must submit an evaluable baseline tumor sample for analysis (either a recent or archival tumor sample)

For Efficacy Expansion Phase Arms F and G:

* Have histologically/cytologically-confirmed unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8, not amenable to local therapy
* Have at least 1 measurable lesion by CT or MRI per RECIST 1.1 by BICR. Cutaneous lesions and other superficial lesions are not considered measurable lesions for the purposes of this protocol, but may be considered as non-target lesions
* Participants with unresectable Stage III or IV disease must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies (combinations with anti-cytotoxic T-lymphocyte associated protein 4 [CTLA-4] agents will not be allowed)
* Participants who receive anti-PD-1 therapy as adjuvant treatment following complete resection of Stage III or IV melanoma and have disease recurrence (unresectable loco-regional disease or distant metastases) while on active treatment or within 6 months of stopping anti-PD-1 are eligible
* Have submitted pre-trial imaging and provided a baseline tumor sample
* Proto-oncogene B-raf (BRAF) V600 mutation-positive melanoma participants should have received targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however, they are not required to progress on this treatment prior to enrollment
* BRAF V600E mutation-positive melanoma participants who have NOT received a BRAF inhibitor (either as adjuvant therapy or in the metastatic disease setting) with lactate dehydrogenase (LDH) < local upper limit of normal (ULN), no clinically significant tumor-related symptoms, and absence of rapidly progressing metastatic melanoma. Approximately 10 participants each from Arms F and G will have 2 mandatory biopsies

For Dose Coformulation Phase Arm I:

* Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for or refused all treatment known to confer clinical benefit
* Meet all requirements for Dose Escalation Phase and Dose Confirmation Phase

For the Coformulation Phase - Arm K (China only):

* Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit
* Be a Chinese participant residing in China.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* For all phases of the study: Has received previous treatment with another agent targeting cytotoxic T lymphocyte leukocyte antigen (CTLA)-4

For Dose Confirmation Phase:

* Has received previous treatment with another agent targeting programmed cell death protein 1 (PD-1), programmed cell death ligand 1 (PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
* Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, or has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
* Has received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment
* Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of administration of quavonlimab.
* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years

For Dose Escalation Cohorts (1-3) and Dose Confirmation Arms (A-E):

* Has known untreated central nervous system (CNS) metastases. Has known carcinomatous meningitis
* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse events (irAE)
* Has had a severe hypersensitivity reaction to treatment with any monoclonal antibody or components of the study drug
* Has any active infection requiring therapy
* Has a history of interstitial lung disease, history of noninfectious pneumonitis that required steroids (or has current pneumonitis), or history of inflammatory bowel disease
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has clinically significant cardiac disease
* Has received a live or live attenuated vaccine within 28 days of planned treatment start
* Has known history of human immunodeficiency virus (HIV) and/or known active Hepatitis B or C infections, and/or known to be positive for hepatitis B surface antigen (HBsAg)/ hepatitis B virus (HBV) DNA
* Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the trial
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with screening and for up to 120 days following cessation of pembrolizumab or pembrolizumab/quavonlimab
* Has not fully recovered from any effects of major surgery without significant detectable infection

For Arm F and G (Efficacy Expansion Phase) and Arm K (Coformulation Phase) ONLY:

* Has known active CNS metastases and/or carcinomatous meningitis
* Has not had resolution of anti-PD-1 antibody-related AEs, including immune-mediated AEs back to Grade =1 or baseline (not applicable to Arm K)
* Has not discontinued steroid treatment for an irAE for at least 2 weeks prior to the first dose of study drug (not applicable to Arm K)
* Has ocular melanoma (not applicable to Arm K)
* Has mucosal melanoma (not applicable to Arm K)
* Has had an allogenic tissue/solid organ transplant

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/04/2024
Sample size
Target
Accrual to date
Final
413
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital. Western Sydney local health district ( Site 0009) - Blacktown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle ( Site 0025) - Waratah
Recruitment hospital [3] 0 0
Melanoma Institute Australia ( Site 0017) - Wollstonecraft
Recruitment hospital [4] 0 0
Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019) - Brisbane
Recruitment hospital [5] 0 0
Cairns and Hinterland Hospital and Health Service ( Site 0020) - Cairns
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research ( Site 0012) - Kurralta Park
Recruitment hospital [7] 0 0
Ballarat Health Services ( Site 0022) - Ballarat
Recruitment hospital [8] 0 0
Alfred Health ( Site 0018) - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4120 - Brisbane
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
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
Virginia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Chile
State/province [8] 0 0
Region M. De Santiago
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
China
State/province [10] 0 0
Chongqing
Country [11] 0 0
China
State/province [11] 0 0
Zhejiang
Country [12] 0 0
France
State/province [12] 0 0
Bouches-du-Rhone
Country [13] 0 0
France
State/province [13] 0 0
Gironde
Country [14] 0 0
France
State/province [14] 0 0
Nord
Country [15] 0 0
France
State/province [15] 0 0
Rhone
Country [16] 0 0
France
State/province [16] 0 0
Val-de-Marne
Country [17] 0 0
Greece
State/province [17] 0 0
Attiki
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
Israel
State/province [20] 0 0
Ramat-Gan
Country [21] 0 0
Italy
State/province [21] 0 0
Napoli
Country [22] 0 0
Italy
State/province [22] 0 0
Padova
Country [23] 0 0
Italy
State/province [23] 0 0
Siena
Country [24] 0 0
Japan
State/province [24] 0 0
Chiba
Country [25] 0 0
Japan
State/province [25] 0 0
Hyogo
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
New Zealand
State/province [27] 0 0
Canterbury
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
Poland
State/province [29] 0 0
Mazowieckie
Country [30] 0 0
Poland
State/province [30] 0 0
Wielkopolskie
Country [31] 0 0
South Africa
State/province [31] 0 0
Gauteng
Country [32] 0 0
South Africa
State/province [32] 0 0
Western Cape
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Gipuzkoa
Country [35] 0 0
Spain
State/province [35] 0 0
Valenciana, Comunitat
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Sweden
State/province [37] 0 0
Skane Lan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT03179436