Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers

Phase I Study of Recombinant Interleukin 15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in Subjects With Refractory Cancers

Background:

The drug Interleukin-15 (IL-15) activates the immune system. The drugs nivolumab and ipilimumab unblock immune cells. The drugs together may allow immune cells to recognize and attack cancer cells, causing tumors to shrink.

Objective:

To test the effects and maximum dose of IL-15, nivolumab, and ipilimumab.

Eligibility:

People ages 18 and older who have cancer that does not respond to treatment

Design:

Participants will be screened with:

• Medical history
• Physical exam
• Heart, blood, and urine tests
• Scans

Tumor biopsy: A small needle removes a tumor sample.

Participants will be in 1 of 3 treatment groups:

• IL-15 with nivolumab
• IL-15 with ipilimumab
• IL-15 with nivolumab and ipilimumab

Participants will take the drugs in four 6-week cycles. IL-15 is injected under the skin. The other two drugs are injected into an arm vein over 60-90 minutes. Participants may need to stay at the hospital 2-3 hours after the first dose of any drug to watch for side effects.

Each cycle will include:

• Weekly blood and urine tests
• 16 IL-15 injections
• 1 ipilimumab injection if applicable
• 3 nivolumab injections if applicable
• Blood tests weekly during cycles 1 and 2
• Urine tests weekly during cycles 1 and 2
• Scans and a tumor biopsy on day 42

After cycle 4, participants will stop taking IL-15. They will continue the other drugs until they can no longer tolerate the side effects, or their cancer gets worse. Those cycles will include:

• 1 ipilimumab injection if applicable
• 3 nivolumab injections if applicable
• Scans every other cycle

After participants stop treatment, their doctor will monitor their side effects for 4 months or until they go away.

Study Overview

• Status: Completed
• Conditions: Metastatic Solid Tumors; Treatment-Refractory Cancers
• Intervention / Treatment: Drug: rhIL-15; Drug: Nivolumab; Diagnostic test: EKG; Diagnostic test: ECHO; Diagnostic test: CT Scan; Drug: Ipilimumab; Procedure: Tumor biopsies

Detailed Description

BACKGROUND:

• Interleukin-15 (IL-15) is a stimulatory cytokine that activates the immune system, inducing proliferation of T lymphocytes and natural killer (NK) cells. Administration of recombinant human IL-15 (rhIL-15) has been shown to result in a dramatic increase of circulating cytotoxic T lymphocytes (CD8+T cells) and NK cells; these changes in immune cell populations suggest potential for anti-tumor activity.
• Immune checkpoint inhibitors, including nivolumab (anti-programmed cell death protein 1 (PD-1) and ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), block the engagement of specific T-cell signaling pathways by tumor cells. These regulatory pathways typically act to downregulate T cell activity and are co-opted by tumors to allow the malignant cells to evade the immune response.
• The combination of rhIL-15 with two checkpoint inhibitor therapies has potential to lead to enhanced immune activation, resulting in anti-tumor T cell responses that are effective in refractory cancers.

PRIMARY OBJECTIVE:

- Determine the safety, toxicity profile, dose-limiting toxicity (DLT) and maximum tolerated doses (MTD) of subcutaneous administration of rhIL-15 given in combination with the anti- CTLA-4 antibody ipilimumab and the anti-PD-1 antibody nivolumab in patients with metastatic or treatment-refractory cancers.

EXPLORATORY OBJECTIVE:

• Assess the clinical activity of rhIL-15, ipilimumab, and nivolumab combination therapy as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune RECIST (iRECIST) response rate of patients treated in this trial.
• Investigate the biological effects of this combination on circulating T cell subsets and on PD-1/programmed death-ligand 1 (PD-L1) expression and immune cell activation in tumor tissue.

ELIGIBILITY:

- Patients greater than or equal to 18 years of age with histologically confirmed solid tumor malignancy that is metastatic or treatment-refractory cancers.

STUDY DESIGN:

• The first 4-6 patients enrolling in the study will be placed into lead-in doublets with a combination of rhIL-15 and either nivolumab OR ipilimumab; once toxicity is cleared in both doublets (i.e., 2 patients enrolled on each doublet remain free of DLTs for 6 weeks) and a safety analysis is reviewed and approved by the Institutional Review Board (IRB), new patients will be enrolled directly onto the triple agent combination.
• For the first four 42-day cycles on the triplet, patients will receive subcutaneous (SC) rhIL-15 on days 1-8 and 22-29, intravenous (IV) nivolumab on days 8, 22, and 36, and IV ipilimumab on day 8. Cycles 5 and onwards will not include treatment with rhIL-15.
• Patients will be encouraged to report any and all adverse events, given the high likelihood of toxicities with the triplet combination therapy.
• Blood for pharmacodynamic (PD) endpoints will be collected throughout the study and tumor biopsies will be collected pretreatment and on cycle 1, day 42 (C1D42) (optional during the doublets and triplet escalation phase, mandatory during the triplet expansion phase)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• INCLUSION CRITERIA:

Subjects must have histologically confirmed solid tumor malignancy that is metastatic or treatment refractory cancers which are not curable or do not have known measures or treatments that are associated with a survival advantage (as defined by the subject or the physician investigator). Enrollment of subjects with tumors that can be safely biopsied is encouraged.

Subjects must have evaluable, or measurable disease defined as greater than or equal to 1 lesion that can be accurately measured in greater than or equal to 1 dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with a spiral computed tomography (CT) scan.

Subjects must have recovered to less than or equal to grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) or stabilized from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks or 5 half-lives earlier, whichever is shorter.

Subjects on bisphosphonates/denosumab for any cancer or on hormone therapy for prostate cancer may continue this therapy. However, subjects with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy or refused or is intolerant of hormonal therapy.

Age greater than or equal to 18 years.

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky or Lansky greater than or equal to 70%.

Subjects must have normal organ and marrow function as defined below:

• Leukocytes greater than or equal to 2,000/mm^3
• Absolute neutrophil count (ANC) greater than or equal 1,500/mm^3
• Platelets greater than or equal to 100,000/mm^3
• Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 1.5 times institutional upper limit of normal (ULN) or if liver metastasis, less than or equal to 2.5 times ULN
• Serum creatinine less than or equal to 1.5 times institutional ULN, OR Creatinine clearance greater than or equal to 50 mL/min/1.73 m^2 for subjects with serum creatinine levels greater than 1.5 times higher than institutional normal
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Subjects with inactive central nervous system (CNS) metastasis are eligible. Inactive CNS metastasis is defined as: no symptoms of brain metastases after successful definitive treatment of brain metastases (surgical resection, whole brain irradiation, stereotactic radiation therapy, or a combination of these) with stable or improved radiographic appearance on magnetic resonance imaging (MRI) scan at least 1 month after completion of treatment.

Subjects may have previously progressed on treatment with one of the 3 agents being used in this trial or treatment with other checkpoint inhibitors, as long as they have recovered from previous toxicity. Subjects that previously progressed on treatment with a combination of any 2 of the 3 agents being used in this trial are eligible for the triplet cohort only.

The effects of ipilimumab, nivolumab, and rhIL-15 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the treatment portion of the study, and for a minimum for 5 months (women) and 7 months (men) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Ability to understand and the willingness to sign a written informed consent document.

Willingness to provide blood and biopsy samples for research purposes if on the expansion phase of the study.

EXCLUSION CRITERIA:

Subjects who have received any prior cytotoxic therapy, immunotherapy, major surgery, antitumor vaccines or monoclonal antibodies in the 4 weeks or 5 half-lives, whichever is shorter, prior to cycle 1, day 1 (C1D1) (6 weeks prior for checkpoint inhibitors such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) or anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) and for nitrosoureas or mitomycin C). Subjects must not have received radiotherapy in the 2 weeks prior to C1D1. Subjects who had grade greater than or equal to 3 immune-related adverse events (irAE) (excluding endocrinopathies) during previous treatment with one of the checkpoint inhibitors are excluded from the trial; subjects who had grade 1 or 2 irAE (including serious AEs) that have resolved to grade 1 are eligible at the discretion of the principal investigator (PI).

Subjects with primary brain cancers or active central nervous system (CNS) metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents on this trial.

Concurrent anticancer therapy (including other investigational agents) with the exception of hormone therapy for breast or prostate cancer. Patients that have received treatment for a different cancer previously and have been disease-free for less than one year are excluded.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cognitive impairment, active substance abuse, or psychiatric illness/social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements.

Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding. Because there is no significant preclinical information regarding the risk to a fetus or newborn infant, pregnant or breastfeeding women will be excluded from participation in this trial.

Documented human immunodeficiency virus (HIV) infection or positive serology. Since rhIL-15 treatment stimulates the subject's immune system to attack their tumor, the defective immune systems of subjects with HIV makes responses to this treatment much less likely to provide benefit and these subjects are not eligible for this trial.

History of severe asthma (subjects with a history of mild asthma that are on or can be switched to non-corticosteroid bronchodilator regimens are eligible).

Patients with 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, should be excluded. The use of inhaled corticosteroids is allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lead-in Doublet A; Lead-in doublet for initial safety evaluation: Recombinant interleukin-15 (rhIL-15) given subcutaneous (SC) days 1-8 and 22- 29 + nivolumab (anti-programmed cell death protein 1 (PD1) given intravenous (IV) on days 8, (IL-15 doses are limited to first 4 cycles only).	Drug: rhIL-15; Recombinant human interleukin 15 (IL-15) is a stimulatory cytokine that activates the immune system, inducing proliferation of T lymphocytes and naturel killer (NK) cells. Administration of recombinant human IL-15 (rhIL-15) has been shown to result in a dramatic increase of circulating cytotoxic T lymphocyte (CD8+T) cells and NK cells; these changes in immune cell populations suggest potential for anti-tumor activity.; Other Names: recombinant human interleukin 15; Drug: Nivolumab; Nivolumab is a humanized monoclonal antibody against programmed death 1 (PD-1), a receptor present on the surface of activated T cells that functions as an immune checkpoint. One of the ligands for PD-1, programmed death-ligand 1 (PD-L1), is commonly expressed by tumor cells. Similar to inhibition of the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) pathway by ipilimumab, blocking of PD-1/PD-L1 signaling by nivolumab allows infiltrating T cells to mount an immune response against the tumor. Nivolumab is approved as a single agent for several cancer types, as well as for the treatment of advanced melanoma in combination with ipilimumab.; Other Names: Opdivo; Diagnostic test: EKG; Pre-study; Other Names: Electrocardiogram; Diagnostic test: ECHO; Pre-study; Other Names: Echocardiogram; Diagnostic test: CT Scan; Restaging every cycle (every 6 weeks) ± 1 week during cycles 1-4 and every 2 cycles (every 12 weeks) ± 1 week thereafter.; Other Names: Computed tomography scan
Experimental: Lead-in Doublet B; Lead-in doublet for initial safety evaluation: Recombinant interleukin-15 (rhIL-15) given subcutaneous (SC) days 1-8 and 22- 29 + ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) given intravenous (IV) on day 8, (IL-15 doses are limited to first 4 cycles only).	Drug: rhIL-15; Recombinant human interleukin 15 (IL-15) is a stimulatory cytokine that activates the immune system, inducing proliferation of T lymphocytes and naturel killer (NK) cells. Administration of recombinant human IL-15 (rhIL-15) has been shown to result in a dramatic increase of circulating cytotoxic T lymphocyte (CD8+T) cells and NK cells; these changes in immune cell populations suggest potential for anti-tumor activity.; Other Names: recombinant human interleukin 15; Diagnostic test: EKG; Pre-study; Other Names: Electrocardiogram; Diagnostic test: ECHO; Pre-study; Other Names: Echocardiogram; Diagnostic test: CT Scan; Restaging every cycle (every 6 weeks) ± 1 week during cycles 1-4 and every 2 cycles (every 12 weeks) ± 1 week thereafter.; Other Names: Computed tomography scan; Drug: Ipilimumab; Ipilimumab is a fully human monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), a receptor present on the surface of activated T cells that functions as an immune checkpoint. Immune checkpoints pathways typically act to downregulate T cell activity and are co-opted by tumors to allow the malignant cells to evade the immune response. Blocking the engagement of CTLA-4 with ipilimumab allows infiltrating T cells to mount an anti-tumor response. Ipilimumab is approved by the Food and Drug Administration (FDA) for the treatment of certain patients with melanoma and has shown clinical activity in other tumor types as well.; Other Names: Yervoy
Experimental: Triplet C; Dose escalation of the triplet combination: Recombinant human interleukin-15 (rhIL-15) given subcutaneous (SC) days 1-8 and 22- 29 + nivolumab (anti-programmed cell death protein 1 (PD1) given intravenous (IV) on days 8 + ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) given intravenous (IV) on day 8, IL-15 will initially be given at 0.5 µg/kg/day (dose level 1, DL1). If the safety profile is acceptable at DL1, the dose of IL-15 will be increased to 1.0 µg/kg/day (DL2) in subsequent patients, then to 2.0 µg/kg/day (DL3) if the safety profile of DL2 is acceptable. (IL-15 doses are limited to first 4 cycles only).	Drug: rhIL-15; Recombinant human interleukin 15 (IL-15) is a stimulatory cytokine that activates the immune system, inducing proliferation of T lymphocytes and naturel killer (NK) cells. Administration of recombinant human IL-15 (rhIL-15) has been shown to result in a dramatic increase of circulating cytotoxic T lymphocyte (CD8+T) cells and NK cells; these changes in immune cell populations suggest potential for anti-tumor activity.; Other Names: recombinant human interleukin 15; Drug: Nivolumab; Nivolumab is a humanized monoclonal antibody against programmed death 1 (PD-1), a receptor present on the surface of activated T cells that functions as an immune checkpoint. One of the ligands for PD-1, programmed death-ligand 1 (PD-L1), is commonly expressed by tumor cells. Similar to inhibition of the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) pathway by ipilimumab, blocking of PD-1/PD-L1 signaling by nivolumab allows infiltrating T cells to mount an immune response against the tumor. Nivolumab is approved as a single agent for several cancer types, as well as for the treatment of advanced melanoma in combination with ipilimumab.; Other Names: Opdivo; Diagnostic test: EKG; Pre-study; Other Names: Electrocardiogram; Diagnostic test: ECHO; Pre-study; Other Names: Echocardiogram; Diagnostic test: CT Scan; Restaging every cycle (every 6 weeks) ± 1 week during cycles 1-4 and every 2 cycles (every 12 weeks) ± 1 week thereafter.; Other Names: Computed tomography scan; Drug: Ipilimumab; Ipilimumab is a fully human monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), a receptor present on the surface of activated T cells that functions as an immune checkpoint. Immune checkpoints pathways typically act to downregulate T cell activity and are co-opted by tumors to allow the malignant cells to evade the immune response. Blocking the engagement of CTLA-4 with ipilimumab allows infiltrating T cells to mount an anti-tumor response. Ipilimumab is approved by the Food and Drug Administration (FDA) for the treatment of certain patients with melanoma and has shown clinical activity in other tumor types as well.; Other Names: Yervoy; Procedure: Tumor biopsies; Triplet C Pre-study and Cycle 1, Week 6.; Other Names: Tumor bx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD) at Which Dose-Limiting Toxicities (DLT) Occurred With rhIL-15 Administered in Combination With Fixed Doses of Nivolumab and Ipilimumab	Here is the maximum tolerated dose (MTD) (i.e., highest dose) of rhIL-15 administered in combination with fixed doses of nivolumab and ipilimumab at which dose-limiting toxicities occurred in ≤1 of 6 participants during cycle 1, dose escalation in participants receiving the triplet combination. A DLT is defined as an adverse event that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents.	Cycle 1 (42 days)
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs	A DLT is defined as an adverse event (AE) that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents.	Cycle 1 (42 days)
Number of Participants Experiencing Dose-Limiting Toxicities (DLT)	Here is the number of participants experiencing dose-limiting toxicities (DLT). A DLT is defined as an adverse event that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents.	Cycle 1 (42 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.	Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jibran Ahmed, M.D., National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.
• Lipson EJ, Drake CG. Ipilimumab: an anti-CTLA-4 antibody for metastatic melanoma. Clin Cancer Res. 2011 Nov 15;17(22):6958-62. doi: 10.1158/1078-0432.CCR-11-1595. Epub 2011 Sep 7.
• Conlon KC, Lugli E, Welles HC, Rosenberg SA, Fojo AT, Morris JC, Fleisher TA, Dubois SP, Perera LP, Stewart DM, Goldman CK, Bryant BR, Decker JM, Chen J, Worthy TA, Figg WD Sr, Peer CJ, Sneller MC, Lane HC, Yovandich JL, Creekmore SP, Roederer M, Waldmann TA. Redistribution, hyperproliferation, activation of natural killer cells and CD8 T cells, and cytokine production during first-in-human clinical trial of recombinant human interleukin-15 in patients with cancer. J Clin Oncol. 2015 Jan 1;33(1):74-82. doi: 10.1200/JCO.2014.57.3329. Epub 2014 Nov 17.
• Waldmann TA, Dubois S, Miljkovic MD, Conlon KC. IL-15 in the Combination Immunotherapy of Cancer. Front Immunol. 2020 May 19;11:868. doi: 10.3389/fimmu.2020.00868. eCollection 2020.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: December 30, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; Checkpoint Inhibitor; Combination Therapy; IL-15; T Cells
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Diagnostic Techniques and Procedures; Diagnosis; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Tomography; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Radiography; Heart Function Tests; Electrodiagnosis; Cardiac Imaging Techniques; Ultrasonography; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Nivolumab; Ipilimumab; Electrocardiography; Tomography, X-Ray Computed; Echocardiography
• Other Study ID Numbers: 180033; 18-C-0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified data in a National Institutes of Health (NIH) - funded or approved public repository, identified data in the Biomedical Translational Research Information System (BTRIS) (automatic for activities in the NIH Clinical Center), and de-identified or identified data with approved outside collaborators under appropriate agreements.
• IPD Sharing Time Frame: At the time of publication or shortly thereafter.
• IPD Sharing Access Criteria: Data will be shared through a National Institutes of Health (NIH) - funded or approved public repository: clinicaltrials.gov, Biomedical Translational Research Information System (BTRIS) (automatic for activities in the NIH Clinical Center), approved outside collaborators under appropriate individual agreements, and publication and/or public presentations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No