Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk

NCT03436862 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SCRI BMT 24
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase II single-arm open-label study of nivolumab as maintenance therapy after autologous stem cell transplantation in patients with Hodgkin lymphoma at risk of relapse or progression.

Conditions

Hodgkin Lymphoma

Keywords

Nivolumab; Autologous Stem Cell Transplant; Blood cancers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Nivolumab as Maintenance Therapy

  Adverse events will be graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE version 4.03).

  Every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation

Secondary Outcomes (1)

• Progression-free Survival (PFS) Kaplan-Meier Estimate at 12 Month Interval

  1 year after date of first dose of study drug for each patient

Study Arms (1)

Nivolumab

EXPERIMENTAL

Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment.

Drug: Nivolumab

Interventions

Nivolumab DRUG

Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.

Also known as: Opdivo

Nivolumab

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age and older with Hodgkin Lymphoma who have received auto-HSCT in the previous 45-120 days.
• Complete response (CR), partial response (PR) or stable disease (SD) to salvage therapy prior to ASCT.
• High risk of residual HL post-ASCT, as determined by 1 of the following:
• Positive positron emission tomography (PET) scan defined by the Deauville scale 3-4 and within 2 months of start of high dose chemotherapy prior to ASCT
• Refractory to frontline therapy
• Relapse \<12 months after frontline therapy
• Relapse ≥12 months after frontline therapy with extra-nodal disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 - 1.
• Adequate hematologic function defined as all of the following:
• Absolute neutrophil count (ANC) ≥1000/μL
• Hemoglobin (Hgb) ≥8 g/dL (transfusions to reach this point are not permitted)
• Platelets ≥50,000/μL (transfusion is not permitted)
• Adequate liver function defined as all of the following:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN)
• Total bilirubin ≤1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)

You may not qualify if:

• Patients that have received an allogenic transplant.
• Post-ASCT or current therapy with other anti-neoplastic or investigational agents.
• Best clinical response of progressive disease prior to ASCT.
• Patients with any autoimmune disease or a history of autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Use of a study drug ≤ 21 days or 5 half-lives (whichever is shorter) prior to the first dose of nivolumab. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of nivolumab is required.
• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
• Pregnant or lactating
• Acute or chronic liver, renal, or pancreatic disease.
• Uncontrolled diabetes mellitus. Patients with Type II diabetes are eligible if they require only oral hypoglycemic agents.
• Any of the following cardiac diseases currently or within the last 6 months:
• Left Ventricular Ejection Fraction (LVEF) \<45% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO)
• QTc interval \>480 ms on screening electrocardiogram (ECG)

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bristol-Myers Squibb: collaborator

Study Sites (6)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

HCA Midwest

Kansas City, Missouri, 64132, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Hematologic Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

CANN.InnovationsMedical@sarahcannon.com

844-710-6157

Study Officials

• Carlos Bachier, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: 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

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: May 23, 2018
• Primary Completion: May 5, 2022
• Study Completion: April 4, 2023
• Last Updated: December 5, 2023
• Results First Posted: June 9, 2023

Record last verified: 2023-06

Locations

US (6)