Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors
Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors
This is a Phase 1b/2, multi-center, open label umbrella study of patients 12 years of age
with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in
the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
with recurrent, progressive, or refractory melanoma or other solid tumors with alterations in
the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Miscellaneous,
Phase I
Phase I/II
Adults
Mol. targeted/Immunotherapy/Biologics
DAY101,
Pimasertib
Berlin, Jordan
National
Vanderbilt University
01-19-2022
Eligibility
12 Years
BOTH
NO
Inclusion Criteria:
Signed informed consent by patients 18 years of age and, assent for patients 12 up to 18 years of age
Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1)
Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging Substudy A-specific inclusion criterion:
Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Substudy B-specific inclusion criterion:
Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.
Exclusion Criteria:
Known presence of concurrent activating mutation
Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO) Substudy A-specific exclusion criterion:
Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy
Signed informed consent by patients 18 years of age and, assent for patients 12 up to 18 years of age
Patients must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1)
Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging Substudy A-specific inclusion criterion:
Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplification through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or agency. Substudy B-specific inclusion criterion:
Patients must have a report of histologically confirmed diagnosis of melanoma or other solid tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) through a tumor or liquid biopsy as assessed by genomic sequencing, PCR, FISH, or another clinically accepted molecular diagnostic method recognized by local laboratory or agency.
Exclusion Criteria:
Known presence of concurrent activating mutation
Patients with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO) Substudy A-specific exclusion criterion:
Prior therapy of any RAS- RAF-, MEK-, or ERK-directed inhibitor therapy
