ClinicalTrials.gg
TerminatedNCT03490760Updated Oct 12, 2023Results posted

Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas

A Phase 2 interventional study of Durvalumab and Radiation Therapy in Adenocarcinoma of the Pancreas, sponsored by Baptist Health South Florida. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Baptist Health South Florida · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow/poor enrollment

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Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-institution, single-arm phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy.

Read the detailed description

This is a single-institution phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy. Pancreatic cancer patients who have received second-line or greater chemotherapy in the metastatic setting are not eligible. Target accrual is 39 patients. Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks will be started and continued during RT and afterwards until the patient experiences either unacceptable toxicity or disease progression, whichever comes first. Patients must have at least three radiographically measurable pancreatic cancer lesions in different organs that have not previously received RT, two of which will receive RT. Eligible lesions include either the primary pancreatic tumor in unresected patients or distant metastatic lesions. Three fractions of 8 Gy each will be prescribed to one lesion during Week 3. Three fractions of 8 Gy each will be prescribed to the second lesion during Week 5.

This is a single-arm trial with continuous monitoring of acute non-hematologic toxicity with the primary endpoint of progression free survival. Efficacy will be evaluated by time to progression or death, whichever comes first, and compared to historical control of chemotherapy alone as reported in the literature.

02

Conditions studied

  • Adenocarcinoma of the Pancreas

Keywords

  • Metastatic Adenocarcinoma of the Pancreas
03

In context

Lead sponsor

Baptist Health South Florida is the lead sponsor of 52 studies on the registry; 18 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) 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

  • -proven pancreatic adenocarcinoma with progression through standard chemotherapy. Chemotherapy given as part of prior chemoradiation does not count as a line of therapy. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy.
  • At least 3 radiographically distinct pancreatic cancer lesions that are measurable by 1.1 criteria, including 2 that are eligible for RT.
  • Lesions that will receive RT are separated by ≥3 cm and none >7 cm in greatest dimension.
  • (ECOG) performance status of 0 or 1.
  • of ≥12 weeks.
  • Adequate liver and kidney function.
  • Adequate blood cell count.
  • Female subjects must either be of non- or must have a negative serum pregnancy test upon study entry.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion criteria

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study
  • Previous enrollment in the present study.
  • Any previous treatment with a programmed cell death 1 or programmed cell death ligand 1 inhibitor including Durvalumab.
  • Prior RT to any lesion that would receive RT on this protocol.
  • Prior RT that could lead to an unacceptably high risk of normal tissue injury due to high cumulative normal tissue dose as determined by the investigator.
  • Subjects who have received more than 1 in the setting.
  • History of another primary except for: 1) malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence; 2) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; 3) adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ).
  • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other agent) ≤14 days prior to the first dose of study drug.
  • Mean corrected for heart rate (QTc) ≥470 ms calculated from 3 (ECGs) using Fridericia's Correction.
  • Current or prior use of medication within 28 days before the first dose of Durvalumab, with the exceptions of intranasal and inhaled or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Any unresolved toxicity (> grade 2, version 4.03) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
  • Any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved immune-related adverse event (irAE) >Grade 1.
  • Active or prior documented disease within the past 2 years NOTE: Subjects with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • History of primary immunodeficiency.
  • History of allogeneic organ transplant.
  • History of liver cirrhosis and class B or C.
  • History of to Durvalumab or any .
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, any subject known to have evidence of acute or chronic , or (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written .
  • Known history of previous clinical diagnosis of tuberculosis
  • History of
  • Receipt of within 30 days prior to study entry or within 30 days of receiving durvalumab
  • Female subjects who are pregnant, breast-feeding or male or female patients of who are not employing an effective method of
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  • Symptomatic or uncontrolled requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
  • Subjects with uncontrolled seizures.
  • Subjects with known radiation hypersensitivity syndromes such as Ataxia-Telangiectasia or Nijmegen Breakage Syndrome
Terms in these criteria, in plain language(27)

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

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

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

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.

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.

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.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

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.

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.

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.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

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.

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.

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.

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.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.

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.

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.

05

Study design

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

Study arms

  • Experimental
    Durvalumab plus Radiation Therapy

    Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.

    Drug: Durvalumab · Radiation: Radiation Therapy

Interventions

  • Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks

  • RadiationRadiation Therapy

    24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time from initiation of durvalumab to progression per RECIST 1.1 or death, whichever comes first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

    Time frame: 1 year

Secondary outcomes

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of the patients who have a complete response (CR) or partial response (PR) as defined by RECIST 1.1. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD).

    Time frame: 1 year

  2. Clinical Benefit Rate (CBR)

    The clinical benefit rate is the percentage of patients that have achieved a CR, PR, or stable disease (SD) as defined by RECIST 1.1. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; PD is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions; SD is defined as not meeting criteria for CR, PR, or SD. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD). Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

    Time frame: 1 year

  3. Time to In-field Progression

    In-field progression is defined as PD according to RECIST 1.1 criteria (at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions) within the original field or area where the participant had been treated with radiation therapy. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD. The time to in-field progression is defined as the time from initiation of treatment to progression within the radiation.

    Time frame: 1 year

  4. Overall Survival (OS)

    OS is defined as the time from first treatment until death. Patients who are alive will be censored at the last date of patient contact.

    Time frame: 1 year

07

Results

Posted Oct 12, 2023
Limitations and caveats
This study was terminated early because of poor enrollment and participants being withdrawn soon after enrollment due to disease progression. Statistical analysis was not possible with the small number of evaluable participants.

Participant flow

Participant flow — Overall Study
MilestoneDurvalumab Plus Radiation Therapy
Started9
Completed7
Not completed2

Outcome measures

PrimaryProgression Free Survival

Time from initiation of durvalumab to progression per RECIST 1.1 or death, whichever comes first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

Time frame:
1 year
Reported as:
Median · days
Progression Free Survival
daysDurvalumab Plus Radiation Therapy
Progression Free Survival53 (51 to 53.5)
SecondaryOverall Response Rate (ORR)

ORR is defined as the percentage of the patients who have a complete response (CR) or partial response (PR) as defined by RECIST 1.1. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD).

Time frame:
1 year
Reported as:
Count of participants · Participants
Overall Response Rate (ORR)
ParticipantsDurvalumab Plus Radiation Therapy
Overall Response Rate (ORR)0
SecondaryClinical Benefit Rate (CBR)

The clinical benefit rate is the percentage of patients that have achieved a CR, PR, or stable disease (SD) as defined by RECIST 1.1. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; PD is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions; SD is defined as not meeting criteria for CR, PR, or SD. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD). Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

Time frame:
1 year
Reported as:
Count of participants · Participants
Clinical Benefit Rate (CBR)
ParticipantsDurvalumab Plus Radiation Therapy
Clinical Benefit Rate (CBR)1
SecondaryTime to In-field Progression

In-field progression is defined as PD according to RECIST 1.1 criteria (at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions) within the original field or area where the participant had been treated with radiation therapy. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD. The time to in-field progression is defined as the time from initiation of treatment to progression within the radiation.

Time frame:
1 year
Reported as:
Median · days
Time to In-field Progression
daysDurvalumab Plus Radiation Therapy
Time to In-field Progression53 (51 to 53.5)
SecondaryOverall Survival (OS)

OS is defined as the time from first treatment until death. Patients who are alive will be censored at the last date of patient contact.

Time frame:
1 year
Reported as:
Median · days
Overall Survival (OS)
daysDurvalumab Plus Radiation Therapy
Overall Survival (OS)85 (75 to 175)

Adverse events

Collected over 1 year, 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Durvalumab Plus Radiation Therapy7/7 (100%)3/7 (42.9%)6/7 (85.7%)
Most frequent serious events
Most frequent serious events
EventDurvalumab Plus Radiation Therapy
HyperglycemiaMetabolism and nutrition disorders1/7
Abdominal painGastrointestinal disorders1/7
SepsisInfections and infestations1/7
Acute cystitisRenal and urinary disorders1/7
Rectal bleedGastrointestinal disorders1/7
GI bleedGastrointestinal disorders1/7
HypoglycemiaMetabolism and nutrition disorders1/7
Most frequent other events
Showing 10 of 23
Most frequent other events
EventDurvalumab Plus Radiation Therapy
DiarrheaGastrointestinal disorders3/7
Abdominal painGastrointestinal disorders2/7
FatigueGeneral disorders2/7
NauseaGastrointestinal disorders2/7
ConstipationGastrointestinal disorders2/7
AnorexiaGastrointestinal disorders2/7
Urinary tract infectionRenal and urinary disorders1/7
Increased alkaline phosphataseHepatobiliary disorders1/7
Back painMusculoskeletal and connective tissue disorders1/7
Testicular painReproductive system and breast disorders1/7

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Durvalumab Plus Radiation Therapy
<=18 years0
Between 18 and 65 years2
>=65 years7
Age, Continuous
Age, Continuous(years)Durvalumab Plus Radiation Therapy
Median71 (66 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Durvalumab Plus Radiation Therapy
Female3
Male6
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Durvalumab Plus Radiation Therapy
Hispanic or Latino6
Not Hispanic or Latino3
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Durvalumab Plus Radiation Therapy
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White9
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Durvalumab Plus Radiation Therapy
United States9
08

Study locations

1 site
  • Miami Cancer Institute at Baptist Health, Inc.
    Miami, Florida 33176, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Jul 2020, 20 months.

Results were first posted in Oct 2023, 3 years 3 months after primary completion.

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

Registered
Mar 14, 2018
First posted
Apr 6, 2018
StartActual
Nov 9, 2018
Primary completionActual
Jul 9, 2020
CompletionActual
Jul 9, 2020
Results first posted
Oct 12, 2023
Last update
Oct 12, 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 Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03490760
Lead sponsor
Baptist Health South Florida
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Nov 9, 2018
Primary completion
Jul 9, 2020
Completion
Jul 9, 2020
Results posted
Oct 12, 2023
Last update
Oct 12, 2023

Study contacts

Michael D. Chuong, MD
principal investigator · Miami Cancer Institute at Baptist Health, Inc.

Oversight

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

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Studies of the drug tested here: Durvalumab

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