ClinicalTrials.gg
CompletedNCT03406858Updated May 3, 2023Results posted

Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 2 interventional study of HER2Bi-Armed Activated T Cells and Laboratory Biomarker Analysis in Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma and Prostate Carcinoma Metastatic in the Bone, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

This phase II trial studies how well pembrolizumab and HER2Bi-armed activated T cells work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. HER2Bi-armed activated T cells are made using T cells and may target and kill cancer cells. Giving pembrolizumab and HER2Bi-armed activated T cells may work better in treating patients with castration resistant prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the clinical efficacy of 8 infusions of HER2 HER2Bi-armed activated T cells (BATs) (up to 10\^10/infusion) twice per week for 4 weeks in combination with pembrolizumab once every 3 weeks starting with one dose 3 weeks before the 1st BATs infusion, by assessing the percentage of patients free of clinical progression at 6 months after registration.

SECONDARY OBJECTIVES:

I. Evaluate phenotype, cytokine profiles and IFN-gamma enzyme-linked immunosorbent spots (ELISpots), cytotoxicity and antibodies directed at laboratory prostate cancer cell lines for proof of principle of immune system activation and to correlate with clinical outcomes of response, progression free survival (PFS), and overall survival (OS).

II. Evaluate the magnitude of change in tumor infiltrating T cells, PD-1 expression, and the Th1/Th2 ratio in prostate cancer tumor tissue before and after immunotherapy and correlate it with the clinical outcomes of response, PFS, and OS.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

02

Conditions studied

  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • Prostate Carcinoma Metastatic in the Bone
  • PSA Progression
  • Stage IV Prostate Adenocarcinoma AJCC v7
03

In context

Lead sponsor

Barbara Ann Karmanos Cancer Institute is the lead sponsor of 161 studies on the registry; 19 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be willing and able to provide written /assent for the trial
  • Have confirmed prostate adenocarcinoma, with
  • Progression by either PSA, (RECIST) 1.1 criteria for or new areas of metastases on bone scan or symptom progression related to prostate cancer despite castrate levels of testosterone; (level \< 50 ng/ml)
  • Be agreeable to continue to maintain castrate levels of testosterone
  • At least 2 weeks should have elapsed since any therapy
  • At least 4 weeks since prior chemotherapy for metastatic disease or at least 2 weeks since prior androgen targeting agents such as ketoconazole, abiraterone, enzalutamide, etc.
  • Discontinue anti-androgens prior to therapy; at least 6 weeks since last dose of bicalutamide or nilutamide and at least 4 weeks from last dose of flutamide
  • Have normal bone marrow, renal and hepatic function as deemed by the treating physician and approved by the clinical principal investigator (PI) Dr. Vaishampayan
  • Not have concurrent anti-cancer therapy
  • Not have concurrent immunosuppressive therapy or medical condition likely to cause immunosuppression
  • Have > 6 months
  • Have a performance status of 0 or 1 on the (ECOG)/Zubrod performance scale
  • Agree to use an adequate method of starting with the first dose of study therapy through 120 days after the last dose of study therapy

    • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
  • Within 10 days of treatment registration: (ANC) >= 1,500 /mcL
  • Within 10 days of treatment registration: >= 100,000 / mcL
  • Within 10 days of treatment registration: >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
  • Within 10 days of treatment registration: Serum creatinine =\< 1.5 X (ULN) OR measured or calculated ( [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
  • Within 10 days of treatment registration: Serum total =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels > 1.5 ULN
  • Within 10 days of treatment registration: (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT] =\< 2.5 X ULN OR =\< 5 X ULN for subjects with liver metastases
  • Within 10 days of treatment registration: Albumin >= 2.5 mg/dL
  • Within 10 days of treatment registration: (INR) or prothrombin time (PT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
  • Within 10 days of treatment registration: Activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Exclusion criteria

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
  • Has a diagnosis of immunodeficiency or is receiving systemic therapy (> 10 mg of prednisone daily or equivalent steroid doses) or any other form of therapy within 7 days prior to the first dose of trial treatment
  • Has a known history of active TB (Bacillus tuberculosis)
  • Has to pembrolizumab or any of its
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or has not recovered (i.e. =\< grade 1 or at baseline) from adverse events due to agents administered earlier; Note: Subjects with =\<grade 2 neuropathy are an exception to this criterion and may qualify for the study
  • Has received major surgery, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Has a known additional that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • Has known active central nervous system (CNS) and/or carcinomatous meningitis; subjects with previously treated may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
  • Has active 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 (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has known history of, or any evidence of active, non-infectious pneumonitis
  • Has an active infection requiring systemic therapy
  • 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
  • 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 prior therapy with an , anti-PD-L1, or anti-PD-L2 agent
  • Has a known history of (HIV) (HIV 1/2 antibodies)
  • Has known active (e.g. hepatitis B surface antigen [HBsAg] reactive) or (e.g. hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Has received a within 30 days of planned start of study therapy; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed
  • Has history of cardiac or pulmonary impairment either by clinical history or symptoms or cardiac \< 40%
Terms in these criteria, in plain language(31)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Treatment (pembrolizumab, HER2Bi-armed activated T cells)

    Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.

    Biological: HER2Bi-Armed Activated T Cells · Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab

Interventions

  • Given IV

    Also known as: Anti-CD3 x Anti-Her2/neu Bispecific Antibody-Armed Activated T Cells, HER2Bi-Armed ATCs

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalPembrolizumab

    Given IV

    Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

06

What researchers measure

Primary outcomes

  1. Progression-free Survival

    Percentage of patients achieving clinical progression-free interval at 6 months from study registration

    Time frame: Up to 6 months

07

Results

Posted Nov 15, 2022
Limitations and caveats
Due to COVID-19 pandemic, cellular therapies were suspended and hence the study was discontinued before the targeted enrollment was reached.

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Started15
Completed13
Not completed2
Withdrew: Failure to receive treatment drug.1
Withdrew: Ineligible1

Outcome measures

PrimaryProgression-free Survival

Percentage of patients achieving clinical progression-free interval at 6 months from study registration

Time frame:
Up to 6 months
Reported as:
Number · percentage of participants
Progression-free Survival
percentage of participantsTreatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Progression-free Survival38.5 (19.3 to 76.5)

Adverse events

Collected over For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)9/14 (64.3%)7/14 (50%)14/14 (100%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTreatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
AnemiaBlood and lymphatic system disorders3/14
Back painMusculoskeletal and connective tissue disorders2/14
FatigueGeneral disorders2/14
Lymphocyte count decreasedInvestigations2/14
Generalized muscle weaknessMusculoskeletal and connective tissue disorders2/14
Abdominal painGastrointestinal disorders1/14
Alkaline phosphatase increasedInvestigations1/14
HypertensionVascular disorders1/14
HypokalemiaMetabolism and nutrition disorders1/14
Immune system disorders - Other, specifyImmune system disorders1/14
Most frequent other events
Showing 10 of 53
Most frequent other events
EventTreatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
FatigueGeneral disorders11/14
ChillsGeneral disorders9/14
NauseaGastrointestinal disorders9/14
HeadacheNervous system disorders7/14
Back painMusculoskeletal and connective tissue disorders4/14
General disorders and administration site conditions - Other, specifyGeneral disorders4/14
VomitingGastrointestinal disorders4/14
HypertensionVascular disorders3/14
Pain in extremityMusculoskeletal and connective tissue disorders3/14
ArthritisMusculoskeletal and connective tissue disorders2/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
<=18 years0
Between 18 and 65 years4
>=65 years9
Age, Continuous
Age, Continuous(years)Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Median69 (57 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Female0
Male13
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White12
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
United States13
08

Study locations

1 site
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Jan 2021, 31 months.

Results were first posted in Nov 2022, 1 year 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2017
First posted
Jan 23, 2018
StartActual
Jun 7, 2018
Primary completionActual
Jan 20, 2021
CompletionActual
Nov 7, 2022
Results first posted
Nov 15, 2022
Last update
May 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03406858
Responsible party
Abhinav Deol (Principal Investigator, Barbara Ann Karmanos Cancer Institute) — Principal investigator
First posted
Jan 23, 2018
Start date
Jun 7, 2018
Primary completion
Jan 20, 2021
Completion
Nov 7, 2022
Results posted
Nov 15, 2022
Last update
May 3, 2023

Study contacts

Abhinav Deol, M.D.
principal investigator · Barbara Ann Karmanos Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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