Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (NCT04652960) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
United States38 participantsStarted 2021-10-21
Plain-language summary
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in patients with mycosis fungoides and Sezary syndrome.
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:
* Patients must have histologically or cytologically confirmed MF or SS, stages IIB to IVB with measurable disease and/or detectable blood involvement based on the Global Cutaneous Lymphoma Response Criteria
* Patients must have had at least one line of prior systemic therapy
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of duvelisib in combination with nivolumab in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%)
* Absolute neutrophil count \>= 1000/mcL
* Platelets \> 75,000/mcL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) or =\< 5 x institutional ULN if with history of Gilbert's syndrome
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
* Creatinine =\< 2.0 x institutional ULN
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B o…
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.
1Since this is a Phase 1 trial focused on finding the safest dose of duvelisib combined with nivolumab, what does that mean for what's currently known about how safe or effective this combination might be for my stage of mycosis fungoides or Sézary syndrome?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — so is there any chance I could still be considered, or should we focus on finding a similar study that is currently open?
3Duvelisib is a PI3K inhibitor and nivolumab is an immunotherapy checkpoint inhibitor — given my specific disease stage and overall health, what kinds of side effects would you be most concerned about if I were to pursue a combination like this?
4Before considering an experimental Phase 1 combination like this, are there standard or approved treatments for my stage of mycosis fungoides or Sézary syndrome that I should try first, and how would those compare?
5If the goal of this trial is partly to establish the right dose rather than to directly treat my disease, how should I weigh that against other trials or treatments where more is already known about the dosing and outcomes?
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.
What they're measuring
1
Maximum tolerated dose or recommended phase II dose (RP2D)
Timeframe: Through completion of 3 cycles (each cycle is 28 days)
2
Incidence of adverse events
Timeframe: For 30 days after last dose of study treatment or until the initiation of alternative treatment, whichever comes first. If removed for an adverse event, the adverse event causing removal will be followed until resolution or stabilization