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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Overall Disease Control
Secondary outcome measures
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
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib

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
2014
Completed Phase 3
~4750
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,111 Total Patients Enrolled
Veronika BachanovaLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,978 Total Patients Enrolled

Media Library

Nivolumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03681561 — Phase 1 & 2
Hodgkin's Lymphoma Research Study Groups: Phase I:Ruxolitinib and Nivolumab, Phase II: Ruxolitinib and Nivolumab
Hodgkin's Lymphoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03681561 — Phase 1 & 2
Nivolumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03681561 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is Ruxolitinib usually prescribed?

"Ruxolitinib is a common and effective treatment for unresectable melanoma, as well as high-risk recurrence of squamous cell carcinoma and primary myelofibrosis."

Answered by AI

Is recruitment still available for this investigation?

"Affirmative. Clinicaltrials.gov presents data indicating that the recruitment process for this clinical trial, which was first published on September 13th 2018 and recently modified on February 16th 2022, is ongoing. 20 participants are required to be enrolled at 4 different sites."

Answered by AI

To what extent is this research being participated in by subjects?

"The sponsor of this trial, Incyte Corporation, requires 20 patients to meet its criteria in order to start the study. This will be conducted within University of Iowa Hospitals and Clinics located in Iowa City and University of Minnesota found in Minneapolis."

Answered by AI

Are there any other investigations that have been conducted on the effectiveness of Ruxolitinib?

"Currently, there are 813 active clinical trials for Ruxolitinib with 94 of them in their third iteration. While Basel, BE is the primary location running these studies, they're also taking place in 43477 other places worldwide."

Answered by AI

How many locations are the trials for this medication taking place?

"This medical research is being conducted at the University of Iowa Hospitals and Clinics, located in Iowa City; the University of Minnesota based in Minneapolis; and lastly, there's a study centre for this trial at the University of Wisconsin-Madison. Additionally, 4 other sites are taking part in this investigation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Veronika Bachanova 2018. "Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03681561.
~2 spots leftby Aug 2024
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