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Ribociclib and Spartalizumab in R/M HNSCC (RISE-HN)
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04213404
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
See Contacts and Locations
Sponsor:
National Taiwan University Hospital
Collaborator:
Novartis
Information provided by (Responsible Party):
National Taiwan University Hospital
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
This study examines the safety and efficacy of ribociclib (CDK 4/6 inhibitors) and spartalizumab (anti-PD1) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma
Drug: Ribociclib
Drug: Spartalizumab
Phase 1
Detailed Description:
The study is a phase I study testing ribociclib (with dose titration plan) and spartalizumab (fixed dose) for R/M HNSCC. The primary endpoints are safety and objective response rate.
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single arm, phase I study with dose titration plan.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ribociclib and Spartalizumab for Head and Neck Squamous Cell Carcinoma, a Phase I Study With Expansion Cohort (RISE-HN)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics: Head and neck squamous cell carcinoma
Drug Information available for: Ribociclib
U.S. FDA Resources
Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: Ribociclib-spartalizumab
Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle Spartalizumab 400mg ivdrip on D1, 28 days a cycle.
Drug: Ribociclib
Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle
Other Name: Kisqali
Drug: Spartalizumab
Spartalizumab 400mg ivdrip on D1, 28 days a cycle.
Other Name: PDR001
Outcome Measures
Go to sections
Primary Outcome Measures :
Adverse events [ Time Frame: 28 days ]
CTCAE 5.0
Objective response rate [ Time Frame: 8 weeks ]
RECIST 1.1
Secondary Outcome Measures :
Progression free survival [ Time Frame: 24 months ]
from study entry to disease progression or death
Overall survival [ Time Frame: 24 months ]
from study entry to death
Duration of response [ Time Frame: 24 months ]
from response to disease progression
Objective response rate (iRECIST) [ Time Frame: 8 weeks ]
iRECIST
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx.
The recurrent disease is not suitable for curative surgery or definitive chemoradiation, and/or metastatic diseases which are not amenable to surgery and/or curative radiotherapy.
Measurable disease according to RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Age: older than 20 years-old, and younger than 70 years-old
ECOG performance status: ≤ 1
Adequate organ function,
Recovered from any previous therapy related toxicity to ≤Grade 1 at study entry (except for stable sensory neuropathy ≤Grade 2 and alopecia)
Patient must have the following laboratory values within local normal range or corrected to within local normal range with supplements before the first dose of study medication:
Sodium
Potassium
Magnesium
Total Calcium (corrected for serum albumin)
Phosphorus
Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the local laboratory
QTcF interval at screening < 450 msec (using Fridericia's correction)
Mean resting heart rate 50-100 bpm (determined from the ECG)
Agree to take biopsy before and during the treatment
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Female subject of childbearing potential should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to have the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment
A male participant must agree to use a contraception of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
Exclusion Criteria:
Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC
For patients with oropharyngeal cancer, positive p16 immunohistochemical (IHC) stain is excluded.
The positivity of p16 IHC is defined as p16 IHC expression ≥ 70
Concurrent malignancies other than HNSCC
Can not take a complete tablet orally.
Hypercalcemia [corrected serum calcium > upper limits of normal (ULN)] in recent 42 days.
Prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors
Prior exposure to ribociclib, palbociclib, or abemaciclib.
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as detectable HCV RNA) infection.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has an active infection requiring systemic therapy 14 days before signing informed consent.
Has received prior radiotherapy within 4 weeks of signing informed consent.
Major surgery within 4 weeks before signing informed consent.
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to signing informed consent.
Has known history of pneumonitis requiring steroids, or any evidence of active, non-infectious pneumonitis, or other known interstitial lung disease
Has a 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 drug.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Topical or inhaled steroids is not considered as systemic treatment.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)
Known brain metastases or leptomeningeal carcinomatosis
History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
Contacts and Locations
Go to sections
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213404
Contacts
Contact: Hsiang-Fong Kao, MD +886223123456 hfkao.tw@gmail.com
Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Hsiang-Fong Kao, MD +886-2-23123456 hfkao.tw@gmail.com
Sponsors and Collaborators
National Taiwan University Hospital
Novartis
Investigators
Principal Investigator: Hsiang-Fong Kao, MD National Taiwan University Hospital
More Information
Go to sections
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04213404 History of Changes
Other Study ID Numbers: 201907017MIPD
CPDR001A0TW01T ( Other Grant/Funding Number: Novartis )
RISE-HN ( Other Identifier: Taiwan FDA )
First Posted: December 30, 2019 Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Taiwan University Hospital:
ribociclib
spartalizumab
PDR001
head and neck squamous cell carcinoma
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
Hide glossaryGlossary
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms
x
Accepts healthy volunteers
Active comparator arm
Adverse event
Age or age group
All-cause mortality
Allocation
Arm
Arm type
Baseline characteristics
Canceled submission
Certain agreements
Certification
Certification/extension first posted
Certification/extension first submitted
Certification/extension first submitted that met QC criteria
City and distance
Clinical study
Clinical trial
ClinicalTrials.gov identifier (NCT number)
Collaborator
Condition/disease
Contact
Country
Cross-over assignment
Data Monitoring Committee (DMC)
Early Phase 1 (formerly listed as Phase 0)
Eligibility criteria
Enrollment
Exclusion criteria
Expanded access
Expanded access status
Expanded access type
Experimental arm
Extension request
Factorial assignment
First posted
First submitted
First submitted that met QC criteria
Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
Funder type
Gender-based eligibility
Group/cohort
Human subjects protection review board
Inclusion criteria
Informed consent
Informed consent form (ICF)
Intervention model
Intervention/treatment
Interventional study (clinical trial)
Investigator
Last update posted
Last update submitted
Last update submitted that met QC criteria
Last verified
Listed location countries
Location terms
Masking
NCT number
No intervention arm
Observational study
Observational study model
Other adverse event
Other study IDs
Other terms
Outcome measure
Parallel assignment
Participant flow
Patient registry
Phase
Phase 1
Phase 2
Phase 3
Phase 4
Phase Not Applicable
Placebo
Placebo comparator arm
Primary completion date
Primary outcome measure
Primary purpose
Principal investigator (PI)
Protocol
Quality control (QC) review
Randomized allocation
Recruitment status
Registration
Removed location countries
Reporting group
Responsible party
Results database
Results delayed
Results first posted
Results first submitted
Results first submitted that met QC criteria
Results returned after quality control review
Results submitted to ClinicalTrials.gov
Secondary outcome measure
Serious adverse event
Sex
Sham comparator arm
Single group assignment
Sort studies by
Sponsor
State
Statistical analysis plan (SAP)
Status
Study completion date
Study design
Study documents
Study IDs
Study record
Study registry
Study results
Study start date
Study type
Submitted date
Title
Title acronym
U.S. Agency for Healthcare Research and Quality (AHRQ)
U.S. Food and Drug Administration (FDA)
Unknown
Skip to Main Content
ClinicalTrials.gov
Find StudiesFind Studies Menu
About StudiesAbout Studies Menu
Submit StudiesSubmit Studies Menu
ResourcesResources Menu
About SiteAbout Site Menu
HomeSearch ResultsStudy Record Detail Save this study
Ribociclib and Spartalizumab in R/M HNSCC (RISE-HN)
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04213404
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
See Contacts and Locations
Sponsor:
National Taiwan University Hospital
Collaborator:
Novartis
Information provided by (Responsible Party):
National Taiwan University Hospital
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
This study examines the safety and efficacy of ribociclib (CDK 4/6 inhibitors) and spartalizumab (anti-PD1) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma
Drug: Ribociclib
Drug: Spartalizumab
Phase 1
Detailed Description:
The study is a phase I study testing ribociclib (with dose titration plan) and spartalizumab (fixed dose) for R/M HNSCC. The primary endpoints are safety and objective response rate.
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single arm, phase I study with dose titration plan.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ribociclib and Spartalizumab for Head and Neck Squamous Cell Carcinoma, a Phase I Study With Expansion Cohort (RISE-HN)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics: Head and neck squamous cell carcinoma
Drug Information available for: Ribociclib
U.S. FDA Resources
Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: Ribociclib-spartalizumab
Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle Spartalizumab 400mg ivdrip on D1, 28 days a cycle.
Drug: Ribociclib
Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle
Other Name: Kisqali
Drug: Spartalizumab
Spartalizumab 400mg ivdrip on D1, 28 days a cycle.
Other Name: PDR001
Outcome Measures
Go to sections
Primary Outcome Measures :
Adverse events [ Time Frame: 28 days ]
CTCAE 5.0
Objective response rate [ Time Frame: 8 weeks ]
RECIST 1.1
Secondary Outcome Measures :
Progression free survival [ Time Frame: 24 months ]
from study entry to disease progression or death
Overall survival [ Time Frame: 24 months ]
from study entry to death
Duration of response [ Time Frame: 24 months ]
from response to disease progression
Objective response rate (iRECIST) [ Time Frame: 8 weeks ]
iRECIST
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx.
The recurrent disease is not suitable for curative surgery or definitive chemoradiation, and/or metastatic diseases which are not amenable to surgery and/or curative radiotherapy.
Measurable disease according to RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Age: older than 20 years-old, and younger than 70 years-old
ECOG performance status: ≤ 1
Adequate organ function,
Recovered from any previous therapy related toxicity to ≤Grade 1 at study entry (except for stable sensory neuropathy ≤Grade 2 and alopecia)
Patient must have the following laboratory values within local normal range or corrected to within local normal range with supplements before the first dose of study medication:
Sodium
Potassium
Magnesium
Total Calcium (corrected for serum albumin)
Phosphorus
Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the local laboratory
QTcF interval at screening < 450 msec (using Fridericia's correction)
Mean resting heart rate 50-100 bpm (determined from the ECG)
Agree to take biopsy before and during the treatment
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Female subject of childbearing potential should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to have the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment
A male participant must agree to use a contraception of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
Exclusion Criteria:
Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC
For patients with oropharyngeal cancer, positive p16 immunohistochemical (IHC) stain is excluded.
The positivity of p16 IHC is defined as p16 IHC expression ≥ 70
Concurrent malignancies other than HNSCC
Can not take a complete tablet orally.
Hypercalcemia [corrected serum calcium > upper limits of normal (ULN)] in recent 42 days.
Prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors
Prior exposure to ribociclib, palbociclib, or abemaciclib.
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as detectable HCV RNA) infection.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has an active infection requiring systemic therapy 14 days before signing informed consent.
Has received prior radiotherapy within 4 weeks of signing informed consent.
Major surgery within 4 weeks before signing informed consent.
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to signing informed consent.
Has known history of pneumonitis requiring steroids, or any evidence of active, non-infectious pneumonitis, or other known interstitial lung disease
Has a 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 drug.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Topical or inhaled steroids is not considered as systemic treatment.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)
Known brain metastases or leptomeningeal carcinomatosis
History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
Contacts and Locations
Go to sections
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213404
Contacts
Contact: Hsiang-Fong Kao, MD +886223123456 hfkao.tw@gmail.com
Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Hsiang-Fong Kao, MD +886-2-23123456 hfkao.tw@gmail.com
Sponsors and Collaborators
National Taiwan University Hospital
Novartis
Investigators
Principal Investigator: Hsiang-Fong Kao, MD National Taiwan University Hospital
More Information
Go to sections
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04213404 History of Changes
Other Study ID Numbers: 201907017MIPD
CPDR001A0TW01T ( Other Grant/Funding Number: Novartis )
RISE-HN ( Other Identifier: Taiwan FDA )
First Posted: December 30, 2019 Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Taiwan University Hospital:
ribociclib
spartalizumab
PDR001
head and neck squamous cell carcinoma
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
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