Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)

Study Overview
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Brief Summary
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A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma

Detailed Description
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A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone, Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Official Title
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Dexamethasone, Cytarabine, Cisplatin and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP-cHL)

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Histologically confirmed Hodgkin's lymphoma Measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral CT scan, min > 15 mm in the longest diameter or > 10 mm in the short axis) World Health Organization (WHO) performance status < 2 Relapsed or refractory to at least one prior treatment line No prior therapy with DHAP or Nivolumab No severe concurrent illness Exclusion Criteria: History of HIV Active Hepatitis B or Hepatitis C infection Uncontrolled infection (requiring intravenous treatment) at the time of enrollment Pregnancy or breastfeeding Somatic or psychiatric disorder making the patient unable to sign informed consent Active or prior documented autoimmune disease requiring systemic treatment No receiving a live vaccine within 30 days prior to first dose of nivolumab History of non-infectious pneumonitis that required steroids Other malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with relapsed/refractory Hodgkin's lymphoma<br>A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma | Drug: Nivolumab<br>* Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma | Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano classification and duration of response | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 | Toxicity parameters based on NCI CTCAE 4.03 grades | up to 6 months | 
| Progression-Free Survival |  | up to 12 months | 
| Overall Survival |  | up to 12 months |