Trial Title:
A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)
NCT ID:
NCT06345729
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
MK-1084
Description:
Oral tablets
Arm group label:
MK-1084 with Pembrolizumab
Intervention type:
Other
Intervention name:
Placebo
Description:
Oral tablets
Arm group label:
Placebo with Pembrolizumab
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
IV infusion
Arm group label:
MK-1084 with Pembrolizumab
Arm group label:
Placebo with Pembrolizumab
Other name:
MK-3475
Other name:
KEYTRUDA ®
Summary:
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as
first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC)
with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and
programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two
primary study hypotheses:
Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus
pembrolizumab with respect to progression free survival (PFS) per Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review
(BICR).
Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus
pembrolizumab with respect to overall survival (OS).
Criteria for eligibility:
Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of NSCLC
- Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC)
Staging Manual, Version 8
- Has measurable disease based on RECIST 1.1
- Has provided tumor tissue that demonstrates PD-L1 expression in ≥50% of tumor cells
- Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
- Has life expectancy of at least 3 months
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed
within 7 days before randomization
- For participant assigned male sex at birth: If capable of producing sperm,
participant must agree to the following during the study treatment period and for at
least 10 days after the last dose of oral intervention: Either be abstinent or must
agree to use male condom plus additional contraceptive method.
- For participant assigned female sex at birth: Either be a person of nonchildbearing
potential (PONCBP) or must agree to follow contraceptive guidance during the study
treatment period and for at least 10 days after the last dose of oral intervention
and 120 days after the last dose of pembrolizumab. Must abstain from breastfeeding
during the study intervention period and for at least 120 days after study
intervention.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if
they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks
and have undetectable HBV viral load before randomization
Exclusion Criteria:
- Diagnosis of small cell lung cancer
- Has active inflammatory bowel disease requiring immunosuppressive medication or
previous clear history of inflammatory bowel disease
- Has a known history of, or active, neurologic paraneoplastic syndrome
- Has an active infection requiring systemic therapy
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
including New York Heart Association Class III or IV congestive heart failure,
unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia,
prolongation of QT interval corrected for heart rate by Fridericia's formula (QTcF)
interval to >470 ms, and/or other serious cardiovascular and cerebrovascular
diseases within the 6 months preceding study intervention
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder or
nonmalignant systemic disease. Examples include, but are not limited to,
uncontrolled major seizure disorder, unstable spinal cord compression, or superior
vena cava syndrome.
- Has one or more of the following ophthalmological findings/conditions: intraocular
diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery
occlusion, diagnosis of retinal degenerative disease pressure >21 mm Hg and/or any
diagnosis of glaucoma
- Is unable to swallow orally administered medication, or has a gastrointestinal
disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or
malabsorption)
- Received prior systemic anticancer therapy for their metastatic NSCLC
- Received prior therapy with an anti-programmed cell death-1 (anti-PD-1),
anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent, or with an
agent directed to another stimulatory or coinhibitory T-cell receptor within 12
months before diagnosis of metastatic NSCLC
- Has received radiotherapy within 2 weeks of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study
intervention
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease
- History of allogeneic tissue/solid organ transplant
- Has not fully recovered from any effects of major surgical procedure. Surgical
procedures that required general anesthesia must be completed at least 2 weeks
before first study intervention administration.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beverly Hills Cancer Center ( Site 0116)
Address:
City:
Beverly Hills
Zip:
90211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
310-432-8955
Facility:
Name:
St. Vincent Frontier Cancer Center-Research ( Site 0105)
Address:
City:
Billings
Zip:
59102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
406-238-6290
Facility:
Name:
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
513-558-2153
Facility:
Name:
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
Address:
City:
Kettering
Zip:
45429
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
855-500-2873
Facility:
Name:
Oncology Consultants P.A. ( Site 0113)
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
713-600-0900
Facility:
Name:
AUSTRAL MEDICAL CENTER ( Site 0302)
Address:
City:
Caba
Zip:
C1019ABS
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5491153271411
Facility:
Name:
Centro Oncologico Korben ( Site 0304)
Address:
City:
Caba
Zip:
C1426AGE
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5491138018573
Facility:
Name:
Frankston Hospital ( Site 3002)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61425733507
Facility:
Name:
One Clinical Research ( Site 3001)
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+61862799466
Facility:
Name:
Hospital de Câncer de Recife ( Site 0447)
Address:
City:
Recife
Zip:
50040-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5581996316566
Facility:
Name:
Oncoclínica Oncologistas Associados ( Site 0441)
Address:
City:
Terezina
Zip:
64049-200
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
55 86 999007799
Facility:
Name:
Liga Norte Riograndense Contra o Câncer ( Site 0439)
Address:
City:
Natal
Zip:
59062-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+558440095595
Facility:
Name:
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica
Address:
City:
Porto Alegre
Zip:
90050-170
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5132148144
Facility:
Name:
Americas ( Site 0431)
Address:
City:
Rio de Janeiro
Zip:
22775-001
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
552132076585
Facility:
Name:
Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
Address:
City:
Talca
Zip:
3465584
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56981340385
Facility:
Name:
Orlandi Oncologia-Oncology ( Site 0503)
Address:
City:
Santiago
Zip:
7500713
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56992214787
Facility:
Name:
FALP-UIDO ( Site 0501)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Centro de Oncología de Precisión-Oncology ( Site 0502)
Address:
City:
Santiago
Zip:
7560908
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56991612199
Facility:
Name:
Bradfordhill-Clinical Area ( Site 0504)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56998744662
Facility:
Name:
Anhui Provincial Cancer Hospital ( Site 3136)
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
15155956976
Facility:
Name:
Beijing Cancer hospital ( Site 3133)
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8601088196497
Facility:
Name:
Beijing Cancer hospital ( Site 3134)
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
861088196479
Facility:
Name:
Beijing Chest Hospital,Capital Medical University ( Site 3104)
Address:
City:
Beijing
Zip:
101149
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
861089500153
Facility:
Name:
Chongqing University Cancer Hospital ( Site 3119)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
15123117697
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
Address:
City:
Guangzhou
Zip:
510160
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13710249454
Facility:
Name:
Southern Medical University Nanfang Hospital ( Site 3128)
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8602062787110
Facility:
Name:
Sun Yat-sen University Cancer Center ( Site 3137)
Address:
City:
Guangzhou
Zip:
510555
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613928791406
Facility:
Name:
Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86 13212760751
Facility:
Name:
Hubei Cancer Hospital ( Site 3126)
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13407192282
Facility:
Name:
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3122
Address:
City:
NanJing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13951699955
Facility:
Name:
Nanjing First Hospital ( Site 3154)
Address:
City:
Nanjing
Zip:
210012
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13382080588
Facility:
Name:
The First Affiliated Hospital of Soochow University ( Site 3146)
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613506218900
Facility:
Name:
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
Address:
City:
Wuxi City
Zip:
214122
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18651581690
Facility:
Name:
The Second Affiliated Hospital of Nanchang University ( Site 3139)
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613767120022
Facility:
Name:
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
Address:
City:
Nanchang
Zip:
330209
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613698091288
Facility:
Name:
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 311
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8618629190366
Facility:
Name:
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 315
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
15992898537
Facility:
Name:
LinYi Cancer Hospital ( Site 3111)
Address:
City:
Linyi
Zip:
276001
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 15963998868
Facility:
Name:
Shanghai Chest Hospital ( Site 3100)
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613601813062
Facility:
Name:
Zhongshan Hospital,Fudan University ( Site 3143)
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18729065764
Facility:
Name:
West China Hospital, Sichuan University ( Site 3140)
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8618980606625
Facility:
Name:
The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
Address:
City:
Chengdu
Zip:
610031
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8618108031333
Facility:
Name:
Sichuan Cancer hospital ( Site 3109)
Address:
City:
Chengdu
Zip:
610042
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613880276636
Facility:
Name:
The Second People's Hospital of Neijiang ( Site 3105)
Address:
City:
Neijiang
Zip:
641000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13698308655
Facility:
Name:
Taizhou Hospital of Zhejiang Province ( Site 3145)
Address:
City:
Linhai
Zip:
317000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13867622009
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613587600968
Facility:
Name:
Matsusaka Municipal Hospital ( Site 3311)
Address:
City:
Matsusaka
Zip:
515-8544
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-598-23-1515
Facility:
Name:
Miyagi Cancer Center ( Site 3301)
Address:
City:
Natori
Zip:
981-1293
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-22-384-3151
Facility:
Name:
Nippon Medical School Hospital ( Site 3306)
Address:
City:
Bunkyo
Zip:
113-8603
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-3-3822-2131
Facility:
Name:
Center Hospital of the National Center for Global Health and Medicine ( Site 3305)
Address:
City:
Shinjuku
Zip:
162-8655
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-3-3202-7181
Facility:
Name:
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)
Address:
City:
Bupyeong-gu
Zip:
21431
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82322805172
Facility:
Name:
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82613797614
Facility:
Name:
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82312498153
Facility:
Name:
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)
Address:
City:
Yangsan
Zip:
50612
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82-10-2870-9389
Facility:
Name:
Chungnam national university hospital ( Site 3602)
Address:
City:
Jung-gu
Zip:
35015
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82-42-280-8035
Facility:
Name:
Kyung Hee University Hospital ( Site 3605)
Address:
City:
Seoul
Zip:
02447
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
821056299552
Facility:
Name:
Korea University Guro Hospital ( Site 3601)
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
821022179216
Facility:
Name:
Auckland City Hospital-Cancer & Blood Research ( Site 3400)
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
021463632
Facility:
Name:
Communal Nonprofit Enterprise "Clinical Center of Oncology, Hematology, Transplantology and Palliati
Address:
City:
Cherkasy
Zip:
18009
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380963078884
Facility:
Name:
Regional Municipal Non-profit Enterprise "Bukovinian Clinica-structural unit of the clinical trials
Address:
City:
Chernivtsi
Zip:
58013
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380955077568
Facility:
Name:
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2215)
Address:
City:
Kryvyi Rih
Zip:
50000
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380973567855
Facility:
Name:
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 2202)
Address:
City:
Ivano-Frankivsk
Zip:
76018
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380978411455
Facility:
Name:
Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)
Address:
City:
Kropyvnytskyi
Zip:
25011
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380508412400
Facility:
Name:
Medical Center "MedOffice Group" ( Site 2219)
Address:
City:
Kiev
Zip:
03022
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380503858689
Facility:
Name:
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital
Address:
City:
Lviv
Zip:
79000
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+380677724757
Facility:
Name:
Rivne Regional Clinical Hospital ( Site 2205)
Address:
City:
Rivne
Zip:
33007
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380503802915
Facility:
Name:
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)
Address:
City:
Vinnytsia
Zip:
21029
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380953105783
Facility:
Name:
ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)
Address:
City:
Lutsk
Zip:
43018
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
380503782998
Start date:
May 24, 2024
Completion date:
February 18, 2031
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06345729
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1084-004&&kw=1084-004
