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PD-1 Inhibitor

Nivolumab + Ruxolitinib for Hodgkin's Lymphoma

Phase 1 & 2

Recruiting

Led By Veronkia Bachanova

Research Sponsored by Veronika Bachanova

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failed at least 2 prior therapies including cytotoxic chemotherapy, autologous transplantation, brentuximab vedotin, allogenic transplantation without active graft versus host disease

Age ≥ 18 years at the time of consent

Must not have

A life-threatening illness, medical condition or organ system dysfunction that could compromise the patient's safety

Active central nervous system (CNS) involvement by lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, given with another drug that is already used to treat cancer. The goal is to find the highest dose of the new drug that is still safe, and to see how well it works in patients with a certain type of cancer that has come back or does not respond to other treatments.

Who is the study for?

Adults over 18 with classical Hodgkin lymphoma that's come back or hasn't responded to treatment, including checkpoint inhibitors. They must have measurable disease, be in fair health (ECOG 0-2), and have normal organ function tests. Participants need prior treatments like chemotherapy and possibly a transplant but should be recovered from these treatments. Women of childbearing age must test negative for pregnancy, and sexually active participants must use contraception.

What is being tested?

The trial is testing the combination of Ruxolitinib with Nivolumab to find the highest dose patients can take without severe side effects (MTD). It's an early-phase study where everyone gets both drugs at varying doses to see how well they work together against relapsed or refractory classical Hodgkin lymphoma.

What are the potential side effects?

Possible side effects include immune system reactions that might affect organs, infusion-related reactions similar to allergic responses, tiredness, issues with blood counts which could increase infection risk or bleeding tendencies, liver enzyme changes indicating liver stress, and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried at least 2 treatments including chemotherapy and transplantation without success.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My bilirubin levels are within the normal range.

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I am a woman who can have children and I have a recent negative pregnancy test.

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My kidneys are functioning well enough, based on a specific test.

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My Hodgkin lymphoma has come back or hasn't responded to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious health issue that could make treatment unsafe for me.

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My lymphoma affects my brain or spinal cord.

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I have heart problems that are not well-managed.

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I am currently taking immunosuppressive drugs, including steroids.

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I do not have an active Hepatitis B or C infection.

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I have severe liver problems.

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I am taking a strong medication that affects liver enzymes or more than 200 mg/day of Fluconazole.

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I cannot or will not take pills.

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I have had an autoimmune disease like hepatitis or colitis in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose

Overall Disease Control

Secondary study objectives

Duration of Response

Frequency and Severity of Adverse Events as assessed by CTCAE v4.0

Overall Response Rate

+2 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

Anaemia

19%

Hypertension

17%

Nasopharyngitis

16%

Weight increased

14%

Herpes zoster

14%

Constipation

14%

Abdominal pain

14%

Headache

12%

Pruritus

12%

Back pain

12%

Epistaxis

12%

Pyrexia

12%

Dizziness

10%

Asthenia

10%

Fatigue

10%

Cough

10%

Oedema peripheral

10%

Arthralgia

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Peripheral artery thrombosis

Vertigo

Acute pulmonary oedema

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II: Ruxolitinib and NivolumabExperimental Treatment2 Interventions

Participants will receive ruxolitinib at 20mg orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.

Group II: Phase I:Ruxolitinib and NivolumabExperimental Treatment2 Interventions

Participants will receive ruxolitinib at their assigned dose taken orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Ruxolitinib

2018

Completed Phase 3

~1170