Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (NCT04652960)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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
2. Patients must have had at least one line of prior systemic therapy
3. 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
4. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%)
5. Absolute neutrophil count \>= 1000/mcL
6. Platelets \> 75,000/mcL
7. Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) or =\< 5 x institutional ULN if with history of Gilbert's syndrome
8. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
9. Creatinine =\< 2.0 x institutional ULN
10. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
11. 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 or better
12. The effects of nivolumab and duvelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of nivolumab and duvelisib. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 7 days prior to the start of nivolumab and duvelisib. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and duvelisib and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• UCHealth University of Colorado Hospital — Aurora, Colorado
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
• Mayo Clinic in Florida — Jacksonville, Florida
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Northwestern University — Chicago, Illinois
• Dana-Farber Cancer Institute — Boston, Massachusetts
• Mayo Clinic in Rochester — Rochester, Minnesota
• Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
• Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
• Washington University School of Medicine — St Louis, Missouri
• Siteman Cancer Center-South County — St Louis, Missouri
• Siteman Cancer Center at Christian Hospital — St Louis, Missouri
• NYP/Weill Cornell Medical Center — New York, New York
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.