Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma

A Phase I Trial of 225Ac-anti-CD33 and PD1-Inhibitor in Recurrent Glioblastoma

This phase I trial studies the side effects and best dose of Actimab-A when given together with cemiplimab (REGN2810) in treating patients with glioblastomas that have come back after a period of improvement (recurrent). Actimab-A consists of the monoclonal antibody lintuzumab combined with the radioactive drug actinium Ac 225. Lintuzumab specifically binds to the cell surface antigen CD33 which is found on the glioblastoma cells and delivers the actinium Ac 225. This may allow the glioblastoma to be found and treated by Actimab-A. Immunotherapy with monoclonal antibodies, such as cemiplimab (REGN2810), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Actimab-A with cemiplimab (REGN2810) may be safe, tolerable and/or effective in treating recurrent glioblastoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Glioblastoma, IDH-Wildtype; Recurrent Gliosarcoma; Recurrent WHO Grade 4 Glioma
• Intervention / Treatment: Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Positron Emission Tomography; Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography; Radiation: Actinium Ac 225 Lintuzumab; Procedure: Radiologic Imaging Procedure

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of actinium Ac 225 lintuzumab (Actimab-A) in combination with cemiplimab (REGN2810) in recurrent glioblastoma.

SECONDARY OBJECTIVES:

I. To observe and record anti-tumor activity. II. To evaluate the impact of baseline tumor mutational burden on response. III. To evaluate the pharmacokinetics of cemiplimab (REGN2810). IV. To evaluate the alpha radiation dosimetry of Actimab-A.

EXPLORATORY OBJECTIVES:

I. To evaluate circulating tumor deoxyribonucleic acid (DNA) (ctDNA) as a predictor for treatment response.

II. To evaluate the impact of baseline tumor expression signatures on response. III. To evaluate the correlation of changes in cytokine production and arginase activity with response.

IV. To evaluate the impact of combination treatment on peripheral immune cells. V. To correlate adverse events (AEs) with absorbed doses of radiation to organs at risk (OARs) such as the kidneys.

OUTLINE: This is a dose-escalation study of Actimab-A in combination with cemiplimab.

Patients receive Actimab-A intravenously (IV) over 30 minutes on either days 1 and 22 of cycles 1-3, days 1 and 22 of cycles 1 and 2, or days 1 and 22 of cycle 1 and day 1 of cycle 2. Patients also receive cemiplimab IV over 30 minutes on days 1 and 22 of each cycle. Cycles repeat every 42 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and radiologic imaging throughout the study and positron emission tomography (PET)/computed tomography (CT) on study. Patients may also optionally undergo single-photon emission computed tomography (SPECT)/CT on study.

After completion of study treatment, patients are followed up at 3 weeks, 30 days, and then every 3 months for up to 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed glioblastoma isocitrate dehydrogenase wild type (IDH-WT) World Health Organization (WHO) grade 4 inclusive of gliosarcoma (Louis et al., 2021)

  • Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots
• Evidence of recurrent disease (RD) that is measurable (1 x 1cm) at first or second relapse demonstrated by disease progression using Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria, unless the recurrence is outside the radiation field or has been histologically documented
• Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen; results of routinely used methods for MGMT methylation testing (e.g., mutagenically separated polymerase chain reaction [MSPCR] or quantitative polymerase chain reaction [PCR] are acceptable)

• Previous first-line treatment with at least radiotherapy (prior dose ≥ 40 gray [Gy])

  • Note: Prior temozolomide, prior tumor-treatment fields and/or Gliadel wafer (if placed at initial tumor resection) are allowed, but none of these are required
• Last radiation ≥ 6 months (182 days) prior to enrollment if received ≥ 60 Gy or ≥ 3 months (84 days) if received < 60 Gy to limit the risk of radiation necrosis
• No previous treatment with anti PD1, PDL1, CTLA-4, or other immune checkpoint inhibitors
• No tumor-directed therapy for most recent progression
• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Actimab-A in combination with cemiplimab (REGN2810) in patients < 18 years of age, children are excluded from this study
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN
• Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within six (6) months are eligible for this trial
• 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
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
• The effects of Actimab-A and cemiplimab (REGN2810) on the developing human fetus are unknown. For this reason and because anti-PD-1 agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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, for the duration of study participation and for at least six (6) months after completion of Actimab-A. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and six (6) months after completion of Actimab-A and cemiplimab (REGN2810) administration
• Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants

Exclusion Criteria:

• Patients who have not recovered to grade 0 or 1 or pre-treatment baseline from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
• Patients who are receiving any other investigational agents
• Presence of extracranial metastatic or leptomeningeal disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Actimab-A and cemiplimab (REGN2810)
• Patients being treated with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-α or interleukin [IL]-2) within four (4) weeks prior to cycle 1 day 1. The study principal investigator (PI) must be consulted if a patient was being treated with any antibody within four (4) half-lives of said antibody

Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha [TNF-α] agents) within two (2) weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:

• Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study

• Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study

  • Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
  • Pregnant women are excluded from this study because cemiplimab (REGN2810) is an anti-PD-1 agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cemiplimab (REGN2810), breastfeeding should be discontinued if the mother is treated with cemiplimab (REGN2810). These potential risks also apply to Actimab-A
  • Early disease progression prior to three (3) months from the completion of radiotherapy
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy defined as dexamethasone > 2 mg/day or bioequivalent for at least three (3) consecutive days within two (2) weeks of start of study drug
  • Has active autoimmune disease that has required systemic treatment in the past two (2) years
  • Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of Actimab-A (Ac225-lintuzumab)
  • Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g., edema reduction) within six (6) weeks (42 days) of initiation of study treatment. This is approximately two (2) half-lives which is justified based on median time to rebound tumor progression following bevacizumab discontinuation (6.1 weeks), median time to clinical deterioration following bevacizumab discontinuation after disease progression from multiple studies indicating that washout periods longer than eight (8) weeks are unlikely to be tolerated, and perioperative outcome data after neoadjuvant bevacizumab demonstrating relative safety of surgical intervention at least four (4) weeks after bevacizumab discontinuation (Sener et al., 2024)
  • Patients who are unable to take spironolactone or eplerenone due to intolerance, allergy, drug-drug interactions, or for any other reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (Actimab-A, cemiplimab); Patients receive Actimab-A IV over 30 minutes on either days 1 and 22 of cycles 1-3, days 1 and 22 of cycles 1 and 2, or days 1 and 22 of cycle 1 and day 1 of cycle 2. Patients also receive cemiplimab IV over 30 minutes on days 1 and 22 of each cycle. Cycles repeat every 42 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and radiologic imaging throughout the study and PET/CT on study. Patients may also optionally undergo SPECT/CT on study.

Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Biological: Cemiplimab; Given IV; Other Names: REGN2810; Cemiplimab RWLC; Cemiplimab-rwlc; Libtayo; REGN 2810; REGN-2810; Procedure: Positron Emission Tomography; Undergo PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; PT; Positron emission tomography (procedure); Procedure: Single Photon Emission Computed Tomography; Undergo SPECT/CT; Other Names: ST; Medical Imaging, Single Photon Emission Computed Tomography; Single Photon Emission Tomography; single-photon emission computed tomography; SPECT; SPECT imaging; SPECT SCAN; SPET; tomography, emission computed, single photon; Tomography, Emission-Computed, Single-Photon; Single-Photon Emission Computed; Procedure: Computed Tomography; Undergo PET/CT and/or SPECT/CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type; Radiation: Actinium Ac 225 Lintuzumab; Given IV; Other Names: Actimab-A; 225Ac-HuM195; Actinium (225Ac) Lintuzumab Satetraxetan; Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195; LINTUZUMAB SATETRAXETAN AC-225; SGN-33 AC-225; Procedure: Radiologic Imaging Procedure; Undergo radiologic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicities (DLTs)	DLT is defined as any grade ≥ 3 non-hematologic toxicity regardless of supportive care or grade ≥ 4 hematologic toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 that occurs during the first six (6) weeks after initiating treatment. DLTs per CTCAE version 5.0 will be tabulated for each dose level.	Up 6 weeks after initiating treatment
Maximum tolerated dose (MTD)	Will use a Bayesian optimal interval design to find the MTD. Recommended phase 2 dose determination will include both the DLT period for the MTD, as well as consideration of later cycle adverse events (AEs) and the overall safety profile, and available correlatives and will be determined by the study team and Cancer Therapy Evaluation Program collaborators.	Up to 18 months
Frequency of AEs	AEs per CTCAE version 5.0 will be tabulated for each dose level.	Up to 30 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Treatment response will be assessed for all patients based on Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria: complete response (CR), partial response (PR), stable disease (SD), and progression of disease (PD). ORR is defined as the addition of CR and PR. ORR rate will be calculated by the proportion of evaluable patients with objective response (CR/PR), along with its exact 95% confidence interval (CI).	Up to 2 years
Progression free survival	Treatment response will be assessed for all patients based on RANO 2.0 criteria: CR, PR, SD, and PD. Kaplan-Meier estimates will be provided. The corresponding median survival time (with 95% CI) will be determined.	From randomization or initiation of treatment to the occurrence of disease progression or death, assessed up to 2 years
Overall survival	Treatment response will be assessed for all patients based on RANO 2.0 criteria: CR, PR, SD, and PD. Kaplan-Meier estimates will be provided. The corresponding median survival time (with 95% CI) will be determined.	From date of diagnosis until the patient's death from any cause, assessed up to 2 years
Tumor mutational burden (TMB) (whole exome sequencing [somatic])	Will evaluate the impact of baseline TMB on response. TMB will be evaluated in each patient and correlation assessment will be performed with clinical activity by Spearman's correlation coefficient. Will also use a logistic regression model to test the association between TMB and ORR.	At baseline
Trough and post end of infusion concentrations of cemiplimab (REGN2810) in serum	Will evaluate the pharmacokinetics (PK) of cemiplimab (REGN2810). PK exposure values will be reported descriptively.	At cycle (C) 1 day (D) 1, C1D22, C2D1, C2D22, C3D1, and C3D22 (Cycle = 42 days)
Absorbed dose estimates (gray) in organs of interest	Will evaluate the alpha radiation dosimetry of Actimab-A. Absorbed dose calculations will be performed following Imaging and Radiation Core guidelines and Medical Internal Radiation Dose Committee methodology, assuming a relative biologic effect of five patients for alpha particles. The absorbed dose estimates to critical organs of each patient at the various administered activity levels will be tabulated using descriptive statistics. A paired T-test, or Wilcoxon signed-rank test if the data is not normally distributed, will be used to detect differences in absorbed dose between time points.	At 4 hours, 24, 48, and 168 hours post-actinium Ac 225 lintuzumab (Actimab-A) during C2 (Cycle = 42 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in variant allele frequencies (VAF) of tumor mutations in circulating tumor deoxyribonucleic acid (ctDNA)	Will evaluate ctDNA as a predictor for treatment response. The detectable VAFs will be assessed and trended during the course of treatment. VAF change will be assessed categorically for each patient (increased or decreased at start of C3 as compared to baseline). The association of VAF change with objective response will be tested using the Fisher's exact test, where p < 0.05 will be considered statistically significant.	Baseline to C3 (Cycle = 42 days)
Expression of immune checkpoint receptors and myeloid derived suppressor cells markers by ribonucleic acid sequencing (RNAseq) on archival tissue	Will evaluate the impact of baseline tumor expression signatures on response. Expression levels will be evaluated in each patient and correlation assessment will be performed between T-cell density, gene response set values and other endpoints such as clinical response by Spearman's correlation coefficient.	At C1D1, C1D8, C1D22, C2D1, C2D22, C3D1, C3D22, and progression of disease (Cycle = 42 days)
Protein expression of CD33 and PD-L1 by immunohistochemistry on archival tissue	Will evaluate the impact of baseline tumor expression signatures on response. Expression levels will be evaluated in each patient and correlation assessment will be performed with clinical response by Spearman's correlation coefficient.	At baseline
Interferon gamma in serum by enzyme-linked immunosorbent assay (ELISA)	Will evaluate the correlation of changes in cytokine production and arginase activity with response. ELISA will quantify interferon gamma evaluated in each patient over time (paired), and between patients (non paired), from baseline to each blood draw at a significance level (alpha) of 0.05, and correlated with objective response will be tested using the Fisher's exact test, where p < 0.05 will be considered statistically significant.	At C1D1, C1D8, C1D22, C2D1, C2D22, C3D1, C3D22, and progression of disease (Cycle = 42 days)
Arginase activity by colorimetric assay in serum and peripheral blood mononuclear cells (PBMCs)	Will evaluate the correlation of changes in cytokine production and arginase activity with response. Arginase activity will be evaluated in each patient over time (paired), and between patients (non paired), from baseline to each blood draw with a parametric (such as t-test) or non-parametric (such as Wilcoxon signed rank / rank sum) test depending on whether the data is normally distributed at a significance level (alpha) of 0.05, and correlated with objective response will be tested using the Fisher's exact test, where p < 0.05 will be considered statistically significant.	At C1D1, C1D8, C1D22, C2D1, C2D22, C3D1, C3D22, and progression of disease (Cycle = 42 days)
Gene expression signatures in PBMCs	Will evaluate the impact of combination treatment on peripheral immune cells. Will include myeloid cell (polarization), T-cells (T-cell receptor [TCR] clonality), interferon, immunosuppression and cell cycle (RNAseq, gene set variation analysis [GSVA]). After correction for batch effect, GSVA scores for each gene set described will be calculated for each patient. Will assess changes within each patient over time from baseline with a parametric (such as t-test) or non-parametric (such as Wilcoxon signed rank) test depending on whether the data is normally distributed (paired within patients) at a significance level (alpha) of 0.05. Will also examine immune cell types bioinformatic deconvolution of the RNAseq data to estimate cell type frequencies. A percentage of TCR overlap of peripheral blood will be calculated and changes over time from baseline will be assessed with a parametric or non-parametric test at a significance level (alpha) of 0.05.	At C1D1, C1D8, C1D22, C2D1, C2D22, C3D1, C3D22, and progression of disease (Cycle = 42 days)
Immune cell characterization (single cell [sc] RNAseq of PBMCs): Myeloid cell phenotypes, TCR clonality and deoxyribonucleic acid (DNA) damage	Will evaluate the impact of combination treatment on peripheral immune cells. Myeloid cell clusters, changes in unique TCR clone frequencies (and their associated phenotypes), and DNA damage and repair pathways (inclusive of cell cycle and apoptosis) will be followed through treatment and changes within each patient over time from baseline to each blood draw with a parametric (such as t-test) or non-parametric (such as Wilcoxon signed rank) test depending on whether the data is normally distributed (paired within patients) at a significance level (alpha) of 0.05. Bulb RNAseq data will be utilized to help prioritize samples to commit to scRNAseq.	At C1D1, C1D8, C1D22, C2D1, C2D22, C3D1, C3D22, and progression of disease (Cycle = 42 days)
Immune cell characterization (flow cytometry of PBMCs): Myeloid cell phenotypes and markers of T-cell activation	Will evaluate the impact of combination treatment on peripheral immune cells. Myeloid cell phenotypes and markers of T-cell activation will be followed through treatment and changes within each patient over time from baseline to each blood draw with a parametric (such as t-test) or non-parametric (such as Wilcoxon signed rank) test depending on whether the data is normally distributed, (paired within patients) at a significance level (alpha) of 0.05.	At C1D1, C1D8, C1D22, C2D1, C2D22, C3D1, C3D22, and progression of disease (Cycle = 42 days)
Absorbed doses of radiation to organs at risk (OARs) and severe side effects	Will explore the correlations of absorbed doses of radiation to OARs and severe side effects. For time to each toxicity event separately, will summarize using the Kaplan-Meier method. AEs will be classified into acute or late events depending on the time from re-irradiation. Univariate logistic regression models will be used to study potential associations between independent variables and toxicity. Receive-operator characteristics analysis will be performed for OAR to study the correlation between events of severe toxicity and absorbed dose. Correlations between cumulated absorbed doses by healthy organs and the variation of laboratory parameters from baseline after each treatment cycle will be assessed with the Spearman correlation coefficient. Linear mixed models will be used to estimate the variations of laboratory measurements over time as a function of the cumulative absorbed doses by organs. Statistical significance will be considered at a significance level (alpha) of 0.05.	Up to 30 days after last dose of study drug

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Megan Mantica, UPMC Hillman Cancer Center LAO

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Gliosarcoma; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Physical Phenomena; Inorganic Chemicals; Elements; Metals; Chemistry Techniques, Analytical; Spectrum Analysis; Metals, Heavy; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Elements, Radioactive; Radioisotopes; Isotopes; Actinoid Series Elements; Specimen Handling; Magnetic Resonance Spectroscopy; X-Rays; Photons; cemiplimab; Actinium
• Other Study ID Numbers: NCI-2026-00892 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); UM1CA186690 (U.S. NIH Grant/Contract); 10713 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No