Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (NCT04652960)
A Phase I Study With an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sézary Syndrome (SS)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
Explore by condition: All Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.