ClinicalTrials.gg
Active, not recruitingNCT02411656Updated Jul 15, 2026Results posted

Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy

A Phase 2 interventional study of Laboratory Biomarker Analysis and Pembrolizumab in Edema, Erythema and Estrogen Receptor Negative, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
71
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent), and who have achieved clinical response or stable disease to prior chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

Primary Objective: To assess the efficacy of MK-3475 as a single agent in patients with metastatic IBC or non-IBC TNBC

EXPLORATORY OBJECTIVES:

  1. To investigate the association between biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC or non-IBC TNBC patients treated with MK-3475.
  2. To determine the disease control rate of metastatic IBC or non-IBC TNBC patients who have achieved clinical response or stable disease to the systemic therapy.
  3. To investigate the association between biomarkers and efficacy by RNA-sequencing of exosomes in blood and tumor for IBC or non-IBC TNBC patients treated with MK-3475.
  4. To investigate the 5-year OS for IBC or non-IBC TNBC patients treated with MK-3475

OUTLINE:

Patients receive pembrolizumab 200mg IV over approximately 30 minutes on day 1. Cycles repeat every 21 days for 8 cycles and then pembrolizumab 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity

After completion of study treatment, patients are followed up at approximately 1 and 3 months.

02

Conditions studied

  • Edema
  • Erythema
  • Estrogen Receptor Negative
  • HER2/Neu Negative
  • Peau d'Orange
  • Progesterone Receptor Negative
  • Recurrent Inflammatory Breast Carcinoma
  • Stage IV Inflammatory Breast Carcinoma
  • Triple-Negative Breast Carcinoma
03

In context

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

This study's enrollment of 71 is above the median of 52 across 401 interventional studies indexed under Edema.

Browse Edema studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

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

04

Who can participate

Ages eligible
18 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

  • Is willing and able to provide written for the trial
  • Is a female or male and >/= 18 years of age
  • Has histological confirmation of normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR \< 10%) without clinical diagnosis of IBC
  • Has stage IV or recurrent disease that has been treated
  • Has clinical response or stable disease for minimum of two months (three cycles of every three week chemotherapy or 8 weeks of weekly regimen, etc.) after receiving any prior chemotherapy for /recurrent disease; a minimum of two cycles (6-8 weeks) of chemotherapy is required to determine clinical response.

Per criteria 1.1, Clinical response for is defined as complete response (CR) or partial response (PR); for non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and pathological lymph nodes >/= 10 to \<15 mm short axis) is defined as persistence of one or more non-target lesion(s) and no increase in overall tumor burden.

  • Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed.
  • Has a performance status of 0-1 on the (ECOG) performance scale
  • Has adequate organ function as determined by the following laboratory values:

>/= 1000 /mcL, >/=100,000 /mcL, >/= 9 g/dL, creatinine levels \< 1.5 x , Total \</= 1.5 x ULN, and AST \</= 2.5 x ULN or \</=5 x ULN for participants with liver metastases.

  • Participants of should be willing to use effective methods of or be surgically sterile, or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of study drug. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Effective methods of birth control include 1). Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); 2).Intrauterine devices (IUDs); 3).Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide. Males must use the male condom (latex or other synthetic material) with spermicide. Females must choose either a Diaphragm with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge).
  • Has negative serum or urine pregnancy test for participants of childbearing potential

Exclusion criteria

Exclusion Criteria:

  • Is currently participating in a study of an anti-cancer agent
  • Has a diagnosis of immunodeficiency or is receiving systemic therapy or any other form of therapy
  • Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery. (Note: Participants with ≤ grade 2 neuropathy, alopecia and general disorders and administration site conditions [per (CTCAE version 4.0) are an exception to this criterion and may qualify for the study)
  • Has a known (other than breast cancer) except basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • Has known active central nervous system (CNS) and/or carcinomatous meningitis; participants with previously treated may participate if they are stable, and have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
  • Has an active disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Has received prior therapy with an , anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Has a known history of (HIV)
  • Has a known active or
  • Have received a within 30 days prior to the first dose of trial treatment
  • Is receiving concurrent anti-cancer therapy for metastatic disease
Terms in these criteria, in plain language(26)

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.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

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.

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.

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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

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.

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.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

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.

05

Study design

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

Study arms

  • Experimental
    Treatment (pembrolizumab)

    Patients receive pembrolizumab 200mg IV over approximately 30 minutes on day 1. Cycles repeat every 21 days for 8 cycles and then pembrolizumab 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity

    Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalPembrolizumab

    Given IV

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

06

What researchers measure

Primary outcomes

  1. To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC

    The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.

    Time frame: 4 months from the start of therapy

Other outcomes

  1. Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab

    PD-L1 satus in tumor tissue was determined by IHC analysis: positive CPS≥ 10, negative CPS \<10. Median OS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).

    Time frame: From the first dose of pembrolizumab up to 5 years

  2. Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab

    PD-L1 expression in tumor tissue was assessed by immunohistochemistry (IHC), with CPS ≥10 defined as PD-L1 positive and CPS \<10 as PD-L1 negative.Median PFS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).

    Time frame: From the first dose of pembrolizumab up to 3 years

  3. To Investigate the Association Between Biomarkers and Efficacy by RNA-sequencing of Exosomes in Blood and Tumor for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab.

    RNA-sequencing will be performed with RNA extracted from plasma at baseline.

    Time frame: Baseline

  4. Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab

    Overall survival time from the registration date was estimated using Kaplan-Meier method.

    Time frame: From registration date to up to 5 years

07

Results

Posted Jul 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Pembrolizumab)
Started45
Completed8
Not completed37
Withdrew: Adverse event4
Withdrew: Clinical progression33

Outcome measures

PrimaryTo Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC

The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.

Time frame:
4 months from the start of therapy
Reported as:
Number · percentage of participants
To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC
percentage of participantsTreatment (Pembrolizumab)
To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC58.1
Other pre-specifiedCorrelation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab

PD-L1 satus in tumor tissue was determined by IHC analysis: positive CPS≥ 10, negative CPS \<10. Median OS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).

Time frame:
From the first dose of pembrolizumab up to 5 years
Reported as:
Median · months
Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab
monthsPD-L1 NegativePD-L1 Positive
Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab26.0 (13.3 to 55.9)31.9 (9.2 to NA)
Other pre-specifiedCorrelation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab

PD-L1 expression in tumor tissue was assessed by immunohistochemistry (IHC), with CPS ≥10 defined as PD-L1 positive and CPS \<10 as PD-L1 negative.Median PFS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).

Time frame:
From the first dose of pembrolizumab up to 3 years
Reported as:
Median · months
Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab
monthsPD-L1 NegativePD-L1 Positive
Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab3.9 (2.5 to 6.5)5.7 (3.4 to NA)
Other pre-specifiedTo Investigate the Association Between Biomarkers and Efficacy by RNA-sequencing of Exosomes in Blood and Tumor for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab.

RNA-sequencing will be performed with RNA extracted from plasma at baseline.

Time frame:
Baseline

No measurements were reported for this outcome.

Other pre-specifiedOverall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab

Overall survival time from the registration date was estimated using Kaplan-Meier method.

Time frame:
From registration date to up to 5 years
Reported as:
Median · years
Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab
yearsTreatment (Pembrolizumab)
Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab2.17 (1.11 to 3.19)

Adverse events

Collected over All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Pembrolizumab)34/45 (75.6%)13/45 (28.9%)40/45 (88.9%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventTreatment (Pembrolizumab)
Disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/45
Adrenal insufficiencyEndocrine disorders2/45
HeadacheNervous system disorders2/45
HypothyroidismEndocrine disorders2/45
InfectionInfections and infestations2/45
Abdominal painGastrointestinal disorders1/45
ColitisGastrointestinal disorders1/45
ConstipationGastrointestinal disorders1/45
DehydrationMetabolism and nutrition disorders1/45
DiarrheaGastrointestinal disorders1/45
Most frequent other events
Showing 10 of 65
Most frequent other events
EventTreatment (Pembrolizumab)
NauseaGastrointestinal disorders20/45
HeadacheNervous system disorders19/45
FatigueGeneral disorders18/45
MyalgiaMusculoskeletal and connective tissue disorders16/45
CoughRespiratory, thoracic and mediastinal disorders15/45
Rash maculo-papularSkin and subcutaneous tissue disorders15/45
VomitingGastrointestinal disorders15/45
DiarrheaGastrointestinal disorders13/45
Nasal congestionRespiratory, thoracic and mediastinal disorders12/45
ConstipationGastrointestinal disorders11/45

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Pembrolizumab)
Median54 (34 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Pembrolizumab)
Female45
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Pembrolizumab)
Hispanic or Latino4
Not Hispanic or Latino38
Unknown or Not Reported3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Pembrolizumab)
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White38
More than one race4
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Pembrolizumab)
United States45
08

Study locations

1 site
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02411656
Responsible party
Sponsor
First posted
Apr 8, 2015
Start date
Jun 11, 2015
Primary completion
Jun 15, 2024
Completion
Dec 31, 2028 (estimated)
Results posted
Jul 2, 2025
Last update
Jul 15, 2026

Study contacts

Bora Lim, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

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

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