ClinicalTrials.gg
TerminatedNCT03465891Updated Jan 12, 2021Results posted

Study of the PD-L1 Inhibitor Atezolizumab With or Without Low-dose, Local Radiation in Patients With Relapsed or Refractory Advanced Stage Follicular Lymphoma

A Phase 2 interventional study of atezolizumab and Low- Dose, Local Radiotherapy in Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Why this study was terminated
Low accrual and lack of funding.
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the safety and effects of atezolizumab with low dose radiation on people with relapsed or refractory follicular lymphoma, In this study, the patient will get either atezolizumab with low dose radiation or, atezolizumab alone. To be better, the atezolizumab and low dose radiation should increase life by 1 year or more compared to the usual approach.

02

Conditions studied

  • Lymphoma

Keywords

  • Advanced Stage Follicular Lymphoma
  • Relapsed
  • Refractory
  • Atezolizumab
  • Dose Local Radiotherapy (2 x 2Gy)
  • 17-360
03

In context

Lymphoma

3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.

This study's enrollment of 2 is below the median of 43 across 2,319 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) 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

  • Signed Form (ICF) Ability and willingness to comply with the requirements of the study protocol
  • Age ≥ 18 years
  • follicular lymphoma grade 1, 2, or 3A

    • Relapsed disease is defined as having relapsed after greater than 6 months of prior treatment for follicular lymphoma
    • Refractory disease is defined as failure to achieve a complete response or relapsed within 6 months of treatment for follicular lymphoma
    • Pretreatment for fresh tumor tissue collection is required
    • If patient has recently undergone a biopsy and has not received any intercurrent anti-lymphoma therapy, archival tissue can be used
  • Stage III/IV disease

    ° Stage II disease is also eligible if disease is not encompassible within a single radiation field, as determined by the radiation oncologist

  • At least 1 prior treatment for follicular lymphoma (no restriction to number or type of prior therapies)

    • Patient treated for transformed diffuse large B cell lymphoma (DLBCL) who have retrograde transformation are eligible provided they have received at least one prior treatment for the follicular lymphoma
  • Site of disease amenable to low-dose, local radiotherapy (2 x 2Gy), as recommended by the radiation oncologist
  • At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by CT scan or magnetic resonance imaging, as defined by the Lugano Classification
  • Adequate hematologic and end organ function:

    • ≥ 1500 cells/µL
    • If there is documented bone marrow involvement of follicular lymphoma, ANC must be >/= 1000 cells/µL
    • count ≥ 75,000/µL
    • If there is documented bone marrow involvement of follicular lymphoma, platelet count must be >/= 50,000/µL
    • ≥ 9.0 g/dL
    • If there is documented bone marrow involvement of follicular lymphoma, hemoglobin must be >/= 8.0 g/dL
    • Total ≤ 1.5 x (ULN)
    • Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
    • and ALT ≤ 3.0 x ULN
    • Patients with liver involvement: AST and/or ALT ≤ 5 x ULN Alkaline phosphatase ≤ 2.5 x ULN
    • Patients with documented liver involvement or bone :

alkaline phosphatase ≤ 5 x ULN

  • Serum creatinine ≤ 1.5 x ULN or ≥ 50 mL/min on the basis of the Cockcroft-Gault estimation:

    (140 - age) x (weight in kg) x (0.85 if female) 72 x (serum creatinine in mg/dL)

  • For female patients of and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of (i.e., one that results in a low failure rate [\< 1% per year] when used consistently and correctly) and to continue its use for 5 months after the last dose of ATEZOLIZUMAB. Women must refrain from donating eggs during this same period

    • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a state (>/= 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mullerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
    • Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
  • (ECOG) Performance Status of 0 or 1
  • Willingness to undergo on-treatment biopsies unless not clinically feasible while on treatment

Exclusion criteria

Exclusion Criteria:

  • Follicular lymphoma grade 3B
  • Concurrent aggressive non-Hodgkin lymphoma (e.g. diffuse large B cell lymphoma [DLBCL])
  • Any anticancer therapy, including chemotherapy, hormonal therapy, therapy, or radiotherapy, within 3 weeks, or 5 half lifes, whichever is shortest, prior to initiation of study treatment. However, the following are allowed:

    • Hormone-replacement therapy or oral
    • Herbal therapy, provided it is discontinued at least 1 week prior to Cycle 1, Day 1
    • Palliative radiotherapy for bone , provided most recent fraction not given within 2 weeks of Cycle 1, Day 1 and most recent fraction was not administered to planned area of radiation while on study.
  • AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 with exception of alopecia or skin/nail hyperpigmentation
  • Bisphosphonate therapy for symptomatic hypercalcemia within 2 weeks of cycle 1, day 1

    ° Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed. Denosumab should not be used while on therapy

  • Known liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
  • Active central nervous system (CNS) involvement of lymphoma

    ° Patients with a history of CNS involvement of lymphoma are eligible, provided they received treatment greater than 30 days prior to cycle 1 day 1 and there is no evidence of involvement on most recent assessment

  • Pregnant, or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.

    ° Women of must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment

  • Known to Chinese hamster ovary cell products, other recombinant human antibodies, or to any component of the atezolizumab formulation
  • Inability to comply with study and follow-up procedures
  • Active or history of disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener"s granulomatosis, Sjögren"s syndrome, Bell"s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis

    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
    • Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
    • Patients with inactive inflammatory bowel disease, not currently receiving therapy, may be eligible.
    • Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
    • Rash must cover less than 10% of body surface area (BSA)
    • Disease is well controlled at baseline and only requiring low potency topical (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
    • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan

    °History of radiation pneumonitis is permitted provided patient is asymptomatic and did not require systemic or inhaled corticosteroids for treatment of symptomatic radiation pneumonitis

  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • History of infection or active (chronic or acute) or infection

    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Active tuberculosis
  • Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1, within 5 months after the final dose, or anticipation that such a live, attenuated vaccine will be required during the study

    ° Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.

  • other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate-specific antigen [PSA] ≤ 10 mg/mL, etc.)

Medication-Related Exclusion Criteria:

  • Prior treatment with , or anti-PD-L1 therapeutic antibody or pathway-targeting agents. Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:

    • Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose
    • No history of severe immune-related adverse effects from ant-CTLA-4 ( Grade 3 and 4)
  • Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-a of interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1
  • Treatment with systemic medication (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 1 week prior to Cycle 1, Day 1.

    • Patient who have received acute, low-dose systemic immunosuppressant medication (e.g., a one-time dose of dexamethasone for nausea or prednisone for intravenous contrast allergy) may be enrolled
    • Palliative systemic steroids for palliation of disease are allowed but must be discontinued at least 7 days prior to cycle 1, day 1
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Patients with prior bone marrow transplantation or prior solid organ transplantation
Terms in these criteria, in plain language(29)

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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.

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).

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.

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.

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.

Metastases

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

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    atezolizumab

    All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).

    Drug: atezolizumab

  • Experimental
    atezolizumab plus low-dose, local radiotherapy

    All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).

    Drug: atezolizumab · Radiation: Low- Dose, Local Radiotherapy

Interventions

  • 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).

  • RadiationLow- Dose, Local Radiotherapy

    4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).

06

What researchers measure

Primary outcomes

  1. Objective Response Rate

    objective response defined as CR or PR; as measured in non-irradiated sites of disease. Response will be assessed by the investigator per the Lugano Classification.

    Time frame: 3 years

07

Results

Posted Jan 12, 2021

Participant flow

Participant flow — Overall Study
MilestoneAtezolizumabAtezolizumab Plus Low-dose, Local Radiotherapy
Started11
Completed00
Not completed11
Withdrew: Withdrawal by subject01
Withdrew: Disease progression10

Outcome measures

PrimaryObjective Response Rate

objective response defined as CR or PR; as measured in non-irradiated sites of disease. Response will be assessed by the investigator per the Lugano Classification.

Time frame:
3 years

No measurements were reported for this outcome.

Adverse events

Collected over N/A - Data were not collected. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atezolizumab———
Atezolizumab Plus Low-dose, Local Radiotherapy———

Baseline characteristics

Study was terminated early due to lack of funding and low accruals.

Age, Continuous
Age, Continuous(years)AtezolizumabAtezolizumab Plus Low-dose, Local RadiotherapyTotal
Mean67 (67 to 67)39 (39 to 39)53 (39 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)AtezolizumabAtezolizumab Plus Low-dose, Local RadiotherapyTotal
Female101
Male011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AtezolizumabAtezolizumab Plus Low-dose, Local RadiotherapyTotal
Hispanic or Latino000
Not Hispanic or Latino112
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AtezolizumabAtezolizumab Plus Low-dose, Local RadiotherapyTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White112
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)AtezolizumabAtezolizumab Plus Low-dose, Local RadiotherapyTotal
United States112
08

Study locations

6 sites
  • Memoral Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey 07920, United States
  • Memoral Sloan Kettering Monmouth
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Commack
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau
    Uniondale, New York 11553, 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 Mar 2018 to primary completion in Dec 2019, 21 months.

Results were first posted in Jan 2021, 1 year after primary completion.

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

Registered
Mar 9, 2018
First posted
Mar 14, 2018
StartActual
Mar 9, 2018
Primary completionActual
Dec 17, 2019
CompletionActual
Dec 17, 2019
Results first posted
Jan 12, 2021
Last update
Jan 12, 2021
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 Jan 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03465891
Collaborators
Genentech, Inc.
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Mar 9, 2018
Primary completion
Dec 17, 2019
Completion
Dec 17, 2019
Results posted
Jan 12, 2021
Last update
Jan 12, 2021

Study contacts

M. Lia Palomba, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

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: Atezolizumab

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