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Hodgkin LymphomaPhase 2NCT03120676

Study of Atezolizumab in Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 study testing Atezolizumab in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a study with the purpose of studying the safety and efficacy of the study drug Atezolizumab in patients with relapsed or refractory Hodgkin lymphoma (HL). Atezolizumab could shrink cancer but it could also cause side effects. This study will also test any good and bad effects the study drug. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
6 sitesUnited States
Study dates
14 Apr 2017to 12 Nov 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form (ICF)
  • Ability and willingness to comply with the requirements of the study protocol
  • Age ≥ 18 years
  • Patient has histologically confirmed diagnosis of Hodgkin lymphoma
  • Patients must have received at least 2 prior regimens and have received or be deemed ineligible for autologous stem cell transplant, and must have received prior brentuximab vedotin.
  • Patients who received prior anti-PD-1 therapy are eligible for cohort 1 only and patients who have not received prior anti-PD-1 therapy are eligible for cohort 2 only.
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  • Patient has at least one measurable nodal lesion (≥ 2 cm) according to RECIL Criteria
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):
  • ANC ≥ 1500 cells/µL
  • WBC counts > 2500/µL
  • Lymphocyte count ≥ 300/µL
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception:
  • Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
  • AST and ALT ≤ 3.0 x ULN with the following exception:
  • Patients with liver involvement: AST and/or ALT ≤ 5 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN with the following exception:
  • Patients with documented liver involvement or bone metastases: alkaline phosphatase ≤ 5 x ULN
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation:
  • (140 - age) x (weight in kg) x (0.85 if female) 72 x (serum creatinine in mg/dL)
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of Atezolizumab
  • Female subject of childbearing potential should have a negative serum pregnancy within 28 days prior to receiving the first dose of study medication.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Who cannot join

  • Patients who have undergone prior allogeneic transplant are excluded only if they remain on any immunosuppression or have signs or symptoms of clinical graft-versus-host disease
  • Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment.
  • Herbal therapy (including herbal therapy intended as anticancer therapy) < 1 week prior to Cycle 1, Day 1
  • AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia
  • Known clinically significant liver disease
  • Active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
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  • Pregnancy, lactation, or breastfeeding
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Inability to comply with study and follow-up procedures
  • History or risk of autoimmune disease, including but not limited to 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 AND without normal thyroid hormone levels on a stable dose of thyroid replacement hormone
  • Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 470 msec.
  • History of Torsades de pointes, ventricular tachycardia, or ventricular fibrillation
  • Uncontrolled heart failure or hypertension or uncontrolled diabetes mellitus
  • Patients with uncontrolled eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations (patients without ophthalmologic involvement, rash covering <10% of the body surface area and requiring only low potency topical steroids, and without exacerbations requiring systemic therapy are eligible.)
  • 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.
  • A history of radiation pneumonitis in the radiation field (fibrosis) is permitted provided that symptoms have resolved.
  • 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 HIV infection or active hepatitis B (chronic or acute) or hepatitis C 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.
  • Patients with 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
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
  • Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 for treatment of active infection (Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible)
  • Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
  • 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 or anticipation that such a live, attenuated vaccine will be required during the study
  • Malignancies other than the disease under study within 5 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 anti-PD-L1 therapies are excluded.
  • °Patients who have received prior treatment with immunotherapy including anti-PD-1 anti-CTLA-4 may be enrolled, provided that there was no history of severe immune-related adverse effects (NCI CTCAE Grade 3 and 4)
  • Treatment with investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer)
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1
  • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York, 11570

Other trials in United States

About this study

Official title: A Phase II Study of Atezolizumab in Relapsed or Refractory Hodgkin Lymphoma

This is a study with the purpose of studying the safety and efficacy of the study drug Atezolizumab in patients with relapsed or refractory Hodgkin lymphoma (HL). Atezolizumab could shrink cancer but it could also cause side effects. This study will also test any good and bad effects the study drug. Other aims include studying biomarkers that will help researchers understand how the drug works.

Being tested
Atezolizumab
Keywords
Relapsed, Refractory, Atezolizumab, 17-191
Medical subject headings
Hodgkin Disease, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle.

Study groups in NCT03120676
Study groupRoleWhat they receive
AtezolizumabExperimentalTreatment will be Atezolizumab administered at 1200 mg IV every 3 weeks. A cycle is defined as 3 weeks of therapy. Therapy will continue until disease progression, intolerable toxicities or death for a maximum duration of treatment of 36 cycles.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    The primary endpoint will be computed as proportions along with exact 95% confidence intervals.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study start14 Apr 2017
  3. Primary completion12 Nov 2018
  4. Study completion12 Nov 2018

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a protocol comprised of a single institution phase II study in HL evaluating the efficacy of atezolizumab.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120676
Sponsor's protocol ID
17-191
Status last verified
Nov 2018
First submitted
17 Apr 2017
Last updated
14 Nov 2019
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03120676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.

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