Study of Atezolizumab in Relapsed or Refractory Hodgkin Lymphoma

NCT03120676 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 17-191
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 6

Brief 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. Other aims include studying biomarkers that will help researchers understand how the drug works.

Conditions

Hodgkin Lymphoma

Keywords

Relapsed; Refractory; Atezolizumab; 17-191

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

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

  12 months

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Treatment 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.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

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

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (6)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Hodgkin Disease; Recurrence

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Anas Younes, MD
• Organization: Memorial Sloan Kettering Cancer Center

younesa@mskcc.org

212-639-5059

Study Officials

• Anas Younes, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a protocol comprised of a single institution phase II study in HL evaluating the efficacy of atezolizumab.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 19, 2017
• Study Start: April 14, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: November 14, 2019
• Results First Posted: November 14, 2019

Record last verified: 2018-11

Locations

US (6)