Phase II study of selpercatinib in children and young adults with RET-altered tumors: arm N of the NCI-COG Pediatric MATCH trial (APEC1621N).
15 affiliations
- 1C.S. Mott Children's Hospital, University of Michigan Medical School, Ann Arbor, MI 48109, United States.
- 2Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH 43205, United States.
- 3Frederick National Laboratory for Cancer Research, National Cancer Institute, National Institutes of Health, Frederick, MD, United States.
- 4University of Texas MD Anderson Cancer Center, Houston, TX, United States.
- 5Center for Biomedical Informatics and Information Technology, NCI, NIH, Bethesda, MD, United States.
- 6Mayo Clinic, Rochester, MN, United States.
- 7Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.
- 8Children's Oncology Group Statistical Center, Monrovia, CA, United States.
- 9Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, TX, United States.
- 10Ann and Robert H. Lurie Children's Hospital, Chicago, IL, United States.
- 11St. Jude Children's Research Hospital, Memphis, TN, United States.
- 12Seattle Children's Hospital, University of Washington, Seattle, WA, United States.
- 13Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, United States.
- 14Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, United States.
- 15Dana-Farber Cancer Institute, Boston, MA, United States.
Abstract
Background
This is a phase II subprotocol of the National Cancer Institute-Children's Oncology Group Pediatric Molecular Analysis for Therapy Choice (MATCH) precision oncology platform trial evaluating selpercatinib, a RET inhibitor, in children and young adults aged 1-21 years with relapsed or refractory solid tumors with RET alterations.Methods
Selpercatinib was given at 90 mg/m2/dose (maximum dose 160 mg/dose) orally twice daily for 28-day cycles until progression or intolerable toxicity. The primary aim was to determine the objective response rate, and secondary objectives included assessing the tolerability of selpercatinib and estimating the progression-free survival.Results
Two patients with papillary thyroid carcinomas harboring CCD6C-RET fusions matched to the subprotocol. One patient was deemed ineligible as they had not yet experienced tumor recurrence. The other patient enrolled and received selpercatinib at 90 mg/m2/dose, completing all 26 cycles of protocol therapy and achieving a partial response confirmed by central imaging review. There were no dose-limiting toxicities, and the patient experienced only grade 1 adverse events attributable to selpercatinib.Conclusion
There was a low match and accrual rate on this MATCH subprotocol, resulting in early termination of the study. The basis for low accrual was likely multifactorial, including the overall rarity of this genetic alteration across pediatric tumor types and accelerated FDA approval of selpercatinib in children ≥12 years old prior to the opening of this subprotocol.Clinical trial registration number
ClinicalTrials.gov (NCT04320888).Irb approved
Initial September 14, 2020.
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BibTeX
@article{franson2026phase,
title = {{Phase II study of selpercatinib in children and young adults with RET-altered tumors: arm N of the NCI-COG Pediatric MATCH trial (APEC1621N).}},
author = {Andrea T Franson and Samara L Potter and P Mickey Williams and Sinchita Roy-Chowdhuri and David R Patton and Brent D Coffey and Joel M Reid and Jin Piao and Lauren Saguilig and Todd A Alonzo and Stacey L Berg and Nilsa C Ramirez and Elizabeth Fox and Brenda J Weigel and Douglas S Hawkins and Margaret M Mooney and Naoko Takebe and James V Tricoli and Katherine A Janeway and Nita L Seibel and Donald Williams Parsons},
journal = {The oncologist},
year = {2026},
month = oct,
doi = {10.1093/oncolo/oyag382},
url = {https://europepmc.org/article/MED/42867148},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Phase II study of selpercatinib in children and young adults with RET-altered tumors: arm N of the NCI-COG Pediatric MATCH trial (APEC1621N).
AU - Andrea T Franson
AU - Samara L Potter
AU - P Mickey Williams
AU - Sinchita Roy-Chowdhuri
AU - David R Patton
AU - Brent D Coffey
AU - Joel M Reid
AU - Jin Piao
AU - Lauren Saguilig
AU - Todd A Alonzo
AU - Stacey L Berg
AU - Nilsa C Ramirez
AU - Elizabeth Fox
AU - Brenda J Weigel
AU - Douglas S Hawkins
AU - Margaret M Mooney
AU - Naoko Takebe
AU - James V Tricoli
AU - Katherine A Janeway
AU - Nita L Seibel
AU - Donald Williams Parsons
PY - 2026
DA - 2026/10/01
JO - The oncologist
DO - 10.1093/oncolo/oyag382
UR - https://europepmc.org/article/MED/42867148
AB - Background This is a phase II subprotocol of the National Cancer Institute-Children's Oncology Group Pediatric Molecular Analysis for Therapy Choice (MATCH) precision oncology platform trial evaluating selpercatinib, a RET inhibitor, in children and young adults aged 1-21 years with relapsed or refractory solid tumors with RET alterations.Methods Selpercatinib was given at 90 mg/m2/dose (maximum dose 160 mg/dose) orally twice daily for 28-day cycles until progression or intolerable toxicity. The primary aim was to determine the objective response rate, and secondary objectives included assessing the tolerability of selpercatinib and estimating the progression-free survival.Results Two patients with papillary thyroid carcinomas harboring CCD6C-RET fusions matched to the subprotocol. One patient was deemed ineligible as they had not yet experienced tumor recurrence. The other patient enrolled and received selpercatinib at 90 mg/m2/dose, completing all 26 cycles of protocol therapy and achieving a partial response confirmed by central imaging review. There were no dose-limiting toxicities, and the patient experienced only grade 1 adverse events attributable to selpercatinib.Conclusion There was a low match and accrual rate on this MATCH subprotocol, resulting in early termination of the study. The basis for low accrual was likely multifactorial, including the overall rarity of this genetic alteration across pediatric tumor types and accelerated FDA approval of selpercatinib in children ≥12 years old prior to the opening of this subprotocol.Clinical trial registration number ClinicalTrials.gov (NCT04320888).Irb approved Initial September 14, 2020.
SN - 1083-7159
SN - 1549-490X
ER -