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Demethylation Agent

Nivolumab + CC-486 for Hodgkin's Lymphoma

Phase 1
Recruiting
Led By Matthew Mei
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance of >= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Patient must have received at least one prior systemic therapy and must not currently be a candidate for stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the safety and best dose of CC-486 (an oral form of azacitidine) when given together with nivolumab in treating patients with Hodgkin lymphoma that does not respond to PD1-based immunotherapy or has come back.

Who is the study for?
Adults with classical Hodgkin lymphoma that's resistant to PD-1 therapy or has relapsed. They must have normal organ function, no severe allergies to nivolumab, and agree to use birth control. Excluded are those with recent transplants, certain autoimmune diseases, active infections, or a history of significant heart disease.Check my eligibility
What is being tested?
The trial is testing the combination of CC-486 (oral azacitidine) and nivolumab for safety and effectiveness in treating Hodgkin lymphoma that hasn't responded to previous treatments. It aims to find the best dose while assessing how well this combo helps the immune system fight cancer.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, digestive issues like nausea or diarrhea, blood cell count changes increasing infection risk, potential liver inflammation indicated by elevated enzymes levels in tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are working well enough, with a creatinine clearance of at least 40 mL/min.
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I've had treatment before but can't have a stem cell transplant now.
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I can perform all my self-care but may not be able to do heavy physical work.
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My diagnosis is classical Hodgkin lymphoma, not the nodular type, confirmed by a specialist.
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I am 18 years old or older.
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I have recovered from side effects of cancer treatment, except for hair loss.
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My blood clotting tests are within normal limits, or if I'm on blood thinners, they're properly adjusted.
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I have a tumor that is larger than 1.5 cm, confirmed by a CT or PET/CT scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity
Overall response rate (ORR)
Secondary outcome measures
Complete response (CR) rate
Duration of response (DOR)
Incidence of adverse events
+2 more

Side effects data

From 2023 Phase 3 trial • 216 Patients • NCT01566695
76%
Nausea
68%
Diarrhoea
63%
Vomiting
49%
Neutropenia
47%
Constipation
28%
Pyrexia
27%
Thrombocytopenia
27%
Febrile neutropenia
27%
Oedema peripheral
26%
Epistaxis
25%
Decreased appetite
23%
Asthenia
21%
Fatigue
20%
Petechiae
18%
Anaemia
15%
Cough
14%
Contusion
13%
Abdominal pain
12%
Dyspnoea
12%
Back pain
11%
Urinary tract infection
11%
Hypokalaemia
9%
Weight decreased
9%
Leukopenia
9%
Insomnia
9%
Pneumonia
9%
Mouth haemorrhage
9%
Hypomagnesaemia
9%
Haematoma
8%
Anxiety
8%
Alanine aminotransferase increased
8%
Arthralgia
7%
Sepsis
7%
Dizziness
7%
Gingival bleeding
7%
Upper respiratory tract infection
7%
Pain in extremity
6%
Depression
6%
Confusional state
6%
Septic shock
6%
Gastrooesophageal reflux disease
6%
Cellulitis
6%
Oral herpes
6%
Serum ferritin increased
6%
Hyperglycaemia
6%
Iron overload
6%
Ecchymosis
6%
Hypotension
5%
Neutropenic sepsis
4%
Fall
3%
Lung infection
3%
General physical health deterioration
3%
Cardiac failure congestive
2%
Tachyarrhythmia
2%
Bone marrow failure
2%
Cardiac failure
2%
Multiple organ dysfunction syndrome
2%
Cholecystitis
2%
Hyperbilirubinaemia
2%
Atypical pneumonia
2%
Bronchopulmonary aspergillosis
2%
Subdural haematoma
2%
Haemorrhage intracranial
2%
Acute kidney injury
2%
Renal failure
1%
Corona virus infection
1%
Febrile infection
1%
Escherichia sepsis
1%
Epididymitis
1%
Renal colic
1%
Gastroenteritis
1%
Prerenal failure
1%
Gastritis
1%
Abdominal pain upper
1%
Myocardial infarction
1%
Pancytopenia
1%
Chronic kidney disease
1%
Lethargy
1%
Groin abscess
1%
Lower respiratory tract infection
1%
Device related infection
1%
Influenza
1%
Klebsiella infection
1%
Haemolytic anaemia
1%
Haemorrhagic anaemia
1%
Acute myocardial infarction
1%
Angina unstable
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Intestinal perforation
1%
Neutropenic colitis
1%
Oesophageal achalasia
1%
Oral mucosal blistering
1%
Rectal haemorrhage
1%
Gait disturbance
1%
Hypothermia
1%
Abscess limb
1%
Arteriovenous fistula site infection
1%
Klebsiella sepsis
1%
Meningitis
1%
Meningitis bacterial
1%
Myringitis
1%
Pneumonia fungal
1%
Pneumonia pneumococcal
1%
Pseudomonal sepsis
1%
Pulmonary mycosis
1%
Respiratory tract infection
1%
Skin infection
1%
Staphylococcal infection
1%
Urinary tract infection bacterial
1%
Viral sepsis
1%
Periorbital haematoma
1%
Febrile nonhaemolytic transfusion reaction
1%
Head injury
1%
Hip fracture
1%
Subdural haemorrhage
1%
Upper limb fracture
1%
Dehydration
1%
Diabetes mellitus inadequate control
1%
Diabetic metabolic decompensation
1%
Hyperkalaemia
1%
Hypoglycaemia
1%
Muscular weakness
1%
Polychondritis
1%
Acute myeloid leukaemia
1%
Bone neoplasm
1%
Bowen's disease
1%
Colon adenoma
1%
Mantle cell lymphoma recurrent
1%
Spinal cord neoplasm
1%
Central nervous system lesion
1%
Transient ischaemic attack
1%
Epilepsy
1%
Generalised tonic-clonic seizure
1%
Acute respiratory distress syndrome
1%
Pleural effusion
1%
Pleurisy
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Hypersensitivity vasculitis
1%
Rash
1%
Rash generalised
1%
Shock haemorrhagic
1%
Cardiogenic shock
1%
Intra-abdominal haemorrhage
1%
Status epilepticus
1%
Syncope
1%
Urinary retention
1%
Prostatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Azacitidine Plus Best Supportive Care
Placebo Plus Best Supportive Care

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CC-486, nivolumab)Experimental Treatment2 Interventions
Patients receive azacitidine PO QD on days 1-7 and nivolumab IV over 30 minutes on day 8. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Oral Azacitidine
2013
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,314 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,219 Total Patients Enrolled
Matthew MeiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

CC-486 (Demethylation Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05162976 — Phase 1
Hodgkin's Lymphoma Research Study Groups: Treatment (CC-486, nivolumab)
Hodgkin's Lymphoma Clinical Trial 2023: CC-486 Highlights & Side Effects. Trial Name: NCT05162976 — Phase 1
CC-486 (Demethylation Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05162976 — Phase 1

Frequently Asked Questions

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

How extensive is the participation in this clinical trial?

"True, the clinicaltrials.gov website confirms that this scientific study is currently recruiting volunteers. This experiment was initially announced on March 1st 2022 and has been modified most recently on February 28th 2022. 30 research participants need to be recruited from a single medical facility in order to complete the trial."

Answered by AI

For what ailments is Oral Azacitidine typically prescribed?

"Oral Azacitidine is regularly employed in the induction of chemotherapy and may be capable of treating various other conditions such as malignant neoplasms, leukemia, myelocytic acute, and unresectable melanoma."

Answered by AI

What should the ultimate result be of this experiment?

"This two-year medical trial is primarily assessing the dose-limiting toxicity of a new drug. Secondary outcomes include progression-free survival, overall survival and any adverse effects recorded using the NCI CTCAE 5.0 scale. To measure these parameters, researchers will be utilizing Kaplan and Meier's product limit method with Greenwood estimator for standard error calculation; 95% confidence intervals are generated via log-log transformation while median values will be determined when available."

Answered by AI

To what degree could Oral Azacitidine be detrimental to patients?

"Limited research exists to verify the safety and effectiveness of Oral Azacitidine, leading our team at Power to give it a score of 1 on their scale."

Answered by AI

Are there any remaining slots available in this clinical research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical research project is currently seeking participants; it was initially posted on March 1st 2022 and recently modified on February 28th of the same year. The investigators are looking for thirty individuals from a single site."

Answered by AI
~12 spots leftby May 2025