A Phase II Single Arm Study of Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 37
- Locations
- 6
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Nivolumab as Maintenance Therapy
Overview
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.
Detailed Description
The primary objective of this study is to evaluate safety and tolerability of nivolumab as maintenance therapy early after autologous stem cell transplant in patients with Hodgkin's Lymphoma (HL).
Eligible patients will receive nivolumab (240 mg IV) every 2 weeks (± 2 days as long as interval between doses is 12-16 days) starting 45-120 post-transplant for up to a maximum of 6 months of treatment. Response to treatment will be assessed 6 months and 1 year post-transplant using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 -
- •Adequate hematologic function defined as all of the following:
- •Absolute neutrophil count (ANC) ≥1000/μL
Exclusion Criteria
- •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
Arms & Interventions
Nivolumab
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.
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Nivolumab as Maintenance Therapy
Time Frame: Every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation
Adverse events will be graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE version 4.03).
Secondary Outcomes
- Progression-free Survival (PFS) Kaplan-Meier Estimate at 12 Month Interval(1 year after date of first dose of study drug for each patient)