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Nivolumab + CC-486 for Hodgkin's Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 216 Patients • NCT01566695Trial Design
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- I have not had a stroke or similar brain event in the last 6 months.My kidneys are working well enough, with a creatinine clearance of at least 40 mL/min.I have had a solid organ transplant.I have had progressive multifocal leukoencephalopathy in the past.I've had treatment before but can't have a stem cell transplant now.I have a history of serious gut conditions that could affect drug absorption or increase risk of gut side effects.I can perform all my self-care but may not be able to do heavy physical work.I have had lung inflammation or disease needing extra oxygen or steroids.My diagnosis is classical Hodgkin lymphoma, not the nodular type, confirmed by a specialist.I have an active hepatitis B or C infection.I am willing to provide a recent or past biopsy sample for the study.I agree to use birth control or not have sex during and up to 5-6 months after the study.My cancer did not respond or worsened after immunotherapy targeting PD-1/PD-L1.My lymphoma has spread to my brain or spinal cord.I have had another cancer, but it has been in remission for at least 2 years.I am not pregnant or breastfeeding.I am taking 10 mg or less of prednisone daily for my lymphoma.I do not have any uncontrolled serious illnesses.I had a stem cell transplant using my own cells within the last 3 months.I have an active HIV infection.I am 18 years old or older.My white blood cell count is healthy for treatment.My blood clotting time is normal or managed if I'm on blood thinners.I had a stem cell transplant more than 6 months ago, with no severe GVHD or recent immunosuppression.I have not received a live vaccine in the last 30 days.I have recovered from side effects of cancer treatment, except for hair loss.My platelet count is at least 75,000/mm^3 without recent transfusions.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're properly adjusted.I have been diagnosed with an immune system disorder.I do not have any uncontrolled infections.My liver enzyme (ALT) levels are within the acceptable range.I have an autoimmune disease.I have a tumor that is larger than 1.5 cm, confirmed by a CT or PET/CT scan.
- Group 1: Treatment (CC-486, nivolumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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