Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer
NCT ID: NCT02339558
Last Updated: 2019-09-13
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
45 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-21
Brief Summary
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This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
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Detailed Description
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PRIMARY OBJECTIVES:
I. Objective tumor response to nivolumab in patients with previously treated recurrent and/or metastatic nasopharyngeal carcinoma (NPC) based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
SECONDARY OBJECTIVES:
I. Tumor response to nivolumab based on immune-related response criteria (IRC). II. Duration of response. III. Progression-free survival and overall survival. IV. Safety and tolerability.
TERTIARY OBJECTIVES:
I. To investigate the effect of nivolumab on tumor burden by analyzing the clearance of plasma Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) during the first 4-6 weeks of treatment.
II. To investigate the association between treatment outcome and immunological markers: a) Intratumoral expression of programmed cell death 1 (PD-1) and programmed cell death-ligand (PD-L1) in archived NPC tissues (mandatory); b) Serum absolute lymphocyte count at baseline and post-treatment (mandatory); and c) Plasma cytokine levels at baseline and serially during the first 8 weeks of treatment; d) Expression of PD-1 in cluster of differentiation (CD)8+ T cells in tumor infiltrating lymphocytes (TIL) at baseline (optional).
III. To investigate functional magnetic resonance imaging (MRI) sequences as an early predictor of response to nivolumab (optional only at Chinese University of Hong Kong \[CUHK\]).
OUTLINE:
Patients receive nivolumab intravenously (IV) over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
I. Objective tumor response to nivolumab in patients with previously treated recurrent and/or metastatic nasopharyngeal carcinoma (NPC) based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
SECONDARY OBJECTIVES:
I. Tumor response to nivolumab based on immune-related response criteria (IRC). II. Duration of response. III. Progression-free survival and overall survival. IV. Safety and tolerability.
TERTIARY OBJECTIVES:
I. To investigate the effect of nivolumab on tumor burden by analyzing the clearance of plasma Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) during the first 4-6 weeks of treatment.
II. To investigate the association between treatment outcome and immunological markers: a) Intratumoral expression of programmed cell death 1 (PD-1) and programmed cell death-ligand (PD-L1) in archived NPC tissues (mandatory); b) Serum absolute lymphocyte count at baseline and post-treatment (mandatory); and c) Plasma cytokine levels at baseline and serially during the first 8 weeks of treatment; d) Expression of PD-1 in cluster of differentiation (CD)8+ T cells in tumor infiltrating lymphocytes (TIL) at baseline (optional).
III. To investigate functional magnetic resonance imaging (MRI) sequences as an early predictor of response to nivolumab (optional only at Chinese University of Hong Kong \[CUHK\]).
OUTLINE:
Patients receive nivolumab intravenously (IV) over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
Conditions
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Nasopharyngeal Nonkeratinizing Carcinoma
Recurrent Nasopharynx Carcinoma
Stage III Nasopharyngeal Carcinoma AJCC v7
Stage IV Nasopharyngeal Carcinoma AJCC v7
Stage IVA Nasopharyngeal Carcinoma AJCC v7
Stage IVB Nasopharyngeal Carcinoma AJCC v7
Stage IVC Nasopharyngeal Carcinoma AJCC v7
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (nivolumab)
Patients receive nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group Type
EXPERIMENTAL
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Nivolumab
Intervention Type
BIOLOGICAL
Given IV
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Intervention Type
OTHER
Nivolumab
Given IV
Intervention Type
BIOLOGICAL
Other Intervention Names
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BMS-936558
MDX-1106
NIVO
ONO-4538
Opdivo
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and the willingness to sign a written informed consent document
* Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at locoregional and/or distant sites; NOTE: patients with local recurrence at the bony skull-base as the only site of index disease are excluded; patients with locoregional recurrence without distant metastases must have undergone radical radiotherapy previously
* Measurable disease according to the RECIST criteria (version 1.1), for the evaluation of measurable disease
* Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery
* Archived or fresh tumor sample available; willingness to donate blood and tissue for mandatory correlative research studies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Absolute neutrophil count \>= 1.5 x 10\^9/L
* Platelet count \>= 100 x 10\^9/L
* Hemoglobin \>= 8.0 g/dL
* Serum alanine aminotransferase (\[ALT\]; serum glutamate-pyruvate transferase \[SGPT\]), or serum aspartate aminotransferase \[AST\] where available at the center) \< 2.5 x upper limit of normal (ULN), OR \< 5 x ULN in the presence of liver metastases
* Serum total bilirubin \< 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin \< 3.0 mg/dL)
* Serum creatinine \< 1.5 x ULN
* Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at locoregional and/or distant sites; NOTE: patients with local recurrence at the bony skull-base as the only site of index disease are excluded; patients with locoregional recurrence without distant metastases must have undergone radical radiotherapy previously
* Measurable disease according to the RECIST criteria (version 1.1), for the evaluation of measurable disease
* Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery
* Archived or fresh tumor sample available; willingness to donate blood and tissue for mandatory correlative research studies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Absolute neutrophil count \>= 1.5 x 10\^9/L
* Platelet count \>= 100 x 10\^9/L
* Hemoglobin \>= 8.0 g/dL
* Serum alanine aminotransferase (\[ALT\]; serum glutamate-pyruvate transferase \[SGPT\]), or serum aspartate aminotransferase \[AST\] where available at the center) \< 2.5 x upper limit of normal (ULN), OR \< 5 x ULN in the presence of liver metastases
* Serum total bilirubin \< 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin \< 3.0 mg/dL)
* Serum creatinine \< 1.5 x ULN
Exclusion Criteria
* Any of the following:
* Chemotherapy =\< 4 weeks prior to registration
* Radiotherapy =\< 4 weeks prior to registration
* Nitrosoureas =\< 6 weeks prior to registration or
* Mitomycin C =\< 6 weeks prior to registration
* Those who have not recovered from adverse events (to grade =\< 1 in severity) due to agents administered more than 4 weeks earlier; prior palliative radiotherapy to bone metastases =\< 2 weeks prior to registration (i.e. prior palliative radiotherapy to bone metastases is allowed if it is performed \> 2 weeks prior to registration)
* Prior investigational agents =\< 4 weeks prior to registration
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Known brain metastases or leptomeningeal metastases; NOTE: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. \> 10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration; patients with treated brain metastases who are deemed clinically stable and without radiological progression on positron emission tomography (PET), MRI or computed tomography (CT) scan performed =\< 8 weeks of study entry, are not excluded; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
* History of severe hypersensitivity reaction to any monoclonal antibody
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception NOTE: breastfeeding should be discontinued if the mother is treated with nivolumab; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; they must adhere to contraception for a period of 31 weeks after the last dose of nivolumab
* For patients with unknown human immunodeficiency virus (HIV) status at the time of enrollment, HIV serology must be tested during screening; patients who are tested positive for HIV could be included if there is an adequate cluster of differentiation 4 (CD4) count (\> 350/ul) on a stable regimen of highly active anti-retroviral therapy (HAART) with no detectable or minimal viral burden, and no active infections
* For patients with unknown hepatitis B virus surface antigen (HbsAg) status, must be tested during study screening; patients who are tested positive test for HBsAg are excluded if they have inadequately controlled hepatitis B and/or Child-Pugh Class B or C cirrhosis; however, patients with adequately controlled hepatitis are not excluded from the study if they satisfy all of the following criteria: (i) must be receiving a nucleoside analog anti-viral drug for 3 or more months; and (ii) have a serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level of less than 100 IU/ml via polymerase chain reaction quantification assays prior to enrollment
* For patients with unknown hepatitis C virus ribonucleic acid (HCV antibody) status, must be tested during study screening; patients who are tested positive for HCV antibody are excluded from the study if they have inadequately controlled hepatitis C and/or Child-Pugh Class B or C cirrhosis; patients with adequately controlled hepatitis are not excluded from the study as defined by having undetectable level of serum HCV antibody level prior to enrollment; patients who are currently on interferon or other anti-HCV therapy will be excluded from study
* Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; NOTE: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =\< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
* Evidence of active or acute (i.e. current, or recent within 4 weeks prior to registration) diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation; patients with abdominal carcinomatosis, a history of non-recent intra-abdominal abscess, or a history of non-recent GI obstruction should be evaluated for the potential need for additional treatment before coming on study
* Chemotherapy =\< 4 weeks prior to registration
* Radiotherapy =\< 4 weeks prior to registration
* Nitrosoureas =\< 6 weeks prior to registration or
* Mitomycin C =\< 6 weeks prior to registration
* Those who have not recovered from adverse events (to grade =\< 1 in severity) due to agents administered more than 4 weeks earlier; prior palliative radiotherapy to bone metastases =\< 2 weeks prior to registration (i.e. prior palliative radiotherapy to bone metastases is allowed if it is performed \> 2 weeks prior to registration)
* Prior investigational agents =\< 4 weeks prior to registration
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Known brain metastases or leptomeningeal metastases; NOTE: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. \> 10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration; patients with treated brain metastases who are deemed clinically stable and without radiological progression on positron emission tomography (PET), MRI or computed tomography (CT) scan performed =\< 8 weeks of study entry, are not excluded; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
* History of severe hypersensitivity reaction to any monoclonal antibody
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception NOTE: breastfeeding should be discontinued if the mother is treated with nivolumab; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; they must adhere to contraception for a period of 31 weeks after the last dose of nivolumab
* For patients with unknown human immunodeficiency virus (HIV) status at the time of enrollment, HIV serology must be tested during screening; patients who are tested positive for HIV could be included if there is an adequate cluster of differentiation 4 (CD4) count (\> 350/ul) on a stable regimen of highly active anti-retroviral therapy (HAART) with no detectable or minimal viral burden, and no active infections
* For patients with unknown hepatitis B virus surface antigen (HbsAg) status, must be tested during study screening; patients who are tested positive test for HBsAg are excluded if they have inadequately controlled hepatitis B and/or Child-Pugh Class B or C cirrhosis; however, patients with adequately controlled hepatitis are not excluded from the study if they satisfy all of the following criteria: (i) must be receiving a nucleoside analog anti-viral drug for 3 or more months; and (ii) have a serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level of less than 100 IU/ml via polymerase chain reaction quantification assays prior to enrollment
* For patients with unknown hepatitis C virus ribonucleic acid (HCV antibody) status, must be tested during study screening; patients who are tested positive for HCV antibody are excluded from the study if they have inadequately controlled hepatitis C and/or Child-Pugh Class B or C cirrhosis; patients with adequately controlled hepatitis are not excluded from the study as defined by having undetectable level of serum HCV antibody level prior to enrollment; patients who are currently on interferon or other anti-HCV therapy will be excluded from study
* Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; NOTE: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =\< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
* Evidence of active or acute (i.e. current, or recent within 4 weeks prior to registration) diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation; patients with abdominal carcinomatosis, a history of non-recent intra-abdominal abscess, or a history of non-recent GI obstruction should be evaluated for the potential need for additional treatment before coming on study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Brigette B Ma
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Cancer Center P2C
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Site Status
Los Angeles County-USC Medical Center
Los Angeles, California, United States
Site Status
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Site Status
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Site Status
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Site Status
City of Hope South Pasadena
South Pasadena, California, United States
Site Status
Moffitt Cancer Center
Tampa, Florida, United States
Site Status
Northwestern University
Chicago, Illinois, United States
Site Status
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Site Status
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Site Status
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Site Status
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Site Status
Mayo Clinic Cancer Center P2C
Rochester, Minnesota, United States
Site Status
Mayo Clinic
Rochester, Minnesota, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China
Site Status
National University Hospital Singapore
Singapore, , Singapore
Site Status
National Cancer Centre
Singapore, , Singapore
Site Status
Johns Hopkins Singapore
Singapore, , Singapore
Site Status
Countries
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United States
China
Singapore
References
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Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2014-02673
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1471
Identifier Type: -
Identifier Source: secondary_id
9742
Identifier Type: OTHER
Identifier Source: secondary_id
9742
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2014-02673
Identifier Type: -
Identifier Source: org_study_id
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