Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis A COG Groupwide Phase 2 Study

Contact:

NCT Number:

Protocol:

AAAV0191

Study Status:

Active/Enrolling

Population:

Pediatrics/Adult

Phase:

II

This trial is an open-label, multi-center Phase 2 study to evaluate the safety and efficacy of the pan-RAF inhibitor DAY101 in patients with relapsed/refractory LCH. The primary aim is to determine overall response rate for children and young adults with relapsed or refractory LCH treated with tovorafenib (DAY101) after 2 cycles and must be maintained 4 weeks later.

Are you Eligible? (Inclusion Criteria)

  • Age at diagnosis: 180 days- <22 years (at time of study enrollment) -Patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry -Patients must have progressive or refractory disease or experience relapse after at least one previous systemic chemotherapy treatment strategy -Patient must meet all eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Childhood and Adolescent Cancers (Pediatric)

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
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