CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed (NCT05162976) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed
United States33 participantsStarted 2022-01-03
Plain-language summary
This phase I trial tests 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 (refractory) to PD1-based immunotherapy or has come back (relapsed). CC-486 is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CC-486 in combination with nivolumab may render nivolumab more effective.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from archival tissue of a biopsy that was performed after the most recent systemic therapy
* Exception may be granted by the principal investigator (PI) if a biopsy is not feasible and/or safe
* Age: \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
* Refractory to PD-1/PD-L1 directed immunotherapy, defined as patients who had prior exposure to PD-1/PD-L1 immunotherapy and either:
* Achieved a best response of PD, or
* Achieved a best response of CR/PR but developed PD while on active PD-1/PD-L1 treatment or within 12 weeks of last dose of PD-1/PD-L1 treatment
* Relapse must have been confirmed histologically (with hematopathology review at the participating institution)
* Exceptions may be granted with study PI approval
* Patient must have received at least one prior systemic therapy and must not currently be candidate for stem cell transplantation
* Measurable disea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing CC-486 combined with nivolumab specifically for Hodgkin lymphoma that has stopped responding to PD-1 therapy — since my disease has already progressed on a PD-1 inhibitor, would this combination approach make sense to discuss as a possible next step, or are there other options we should try first?
2Since this is a Phase 1 trial primarily measuring dose-limiting toxicity, what does that mean for what we know — and don't yet know — about the safety and effectiveness of adding CC-486 to nivolumab in this setting?
3The trial is currently active but no longer enrolling new patients — does that mean this combination could still become available to me through other means, like a compassionate use program or a follow-up study, once results are published?
4One of the main things this trial is measuring is overall response rate in people whose lymphoma is refractory to PD-1 therapy — given my treatment history, how would you interpret any early results from this study when thinking about my own treatment options?
5Are there currently any other clinical trials or standard treatments targeting Hodgkin lymphoma that has relapsed or become refractory to PD-1 therapy that you think I should be comparing against this approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.