Evidence map›Paper›PMID 38873934›Full record

Trial reportThe oncologist2024

Phase II study of vemurafenib in children and young adults with tumors harboring BRAF V600 mutations: NCI-COG pediatric MATCH trial (APEC1621) Arm G.

Marie V Nelson, AeRang Kim, P Mickey Williams, Sinchita Roy-Chowdhuri, David R Patton, Brent D Coffey, Joel M Reid, Jin Piao, Lauren Saguilig, Todd A Alonzo and 12 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03220035 (NCI-COG Pediatric MATCH), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03220035 phase2completednot on this map

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Vemurafenib in Patients With Tumors Harboring BRAF V600 Mutations

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2017 to 2024Enrolled4ConditionsAdvanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma, Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma, EpendymomaArmsLaboratory Biomarker Analysis, Vemurafenib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Marie V NelsonChildren's National Hospital, Washington, DC 20010, United States.
AeRang KimChildren's National Hospital, Washington, DC 20010, United States.ORCID 0000-0002-7813-5568
P Mickey WilliamsFrederick National Laboratory for Cancer Research, Frederick MD 21701, United States.
Sinchita Roy-ChowdhuriUniversity of Texas MD Anderson Cancer Center, Houston, TX 77030, United States.
David R PattonCenter for Biomedical Informatics and Information Technology, NCI, NIH, Bethesda, MD 20892, United States.
Brent D CoffeyCenter for Biomedical Informatics and Information Technology, NCI, NIH, Bethesda, MD 20892, United States.
Joel M ReidMayo Clinic, Rochester, MN 55905, United States.
Jin PiaoKeck School of Medicine, University of Southern California, Los Angeles, CA 90089, United States.
Lauren SaguiligChildren's Oncology Group Statistical Center, Monrovia, CA 91016, United States.
Todd A AlonzoKeck School of Medicine, University of Southern California, Los Angeles, CA 90089, United States.
Stacey L BergTexas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, TX 77030, United States.
Nilsa C RamirezBiopathology Center, Research Institute at Nationwide Children's Hospital, Columbus, OH 43205, United States.
Alok JajuAnn and Robert H. Lurie Children's Hospital, Chicago, IL 60611, United States.
Elizabeth FoxSt Jude Children's Research Hospital, Memphis, TN 38105, United States.
Brenda J WeigelUniversity of Minnesota/Masonic Cancer Center, Minneapolis, MD 55455, United States.
Douglas S HawkinsSeattle Children's Hospital and University of Washington, Seattle, WA 98105, United States.ORCID 0000-0003-3602-1375
Margaret M MooneyDivision of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, United States.ORCID 0000-0002-6998-8331
Naoko TakebeDivision of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, United States.
James V TricoliDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, United States.
Katherine A JanewayDepartment of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, United States.
Nita L SeibelDivision of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, United States.
D Williams ParsonsTexas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, TX 77030, United States.

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
COG U24 Funding 2026-2027U24CA196173 · NCI · RESEARCH INST NATIONWIDE CHILDREN'S HOSP · PI Mignon Lee-Cheun Loh, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$62.5M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS U24 CA196173
6 · The paper itself

Abstract

backgroundThis is a phase II subprotocol of the NCI-COG Pediatric MATCH study evaluating vemurafenib, a selective oral inhibitor of BRAF V600 mutated kinase, in patients with relapsed or refractory solid tumors harboring BRAF V600 mutations.

methodsPatients received vemurafenib at 550 mg/m2 (maximum 960 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 estimating progression-free survival and assessing the tolerability of vemurafenib.

resultsTwenty-two patients matched to the subprotocol and 4 patients (18%) enrolled. Primary reasons for non-enrollment were ineligibility due to exclusions of low-grade glioma (n = 7) and prior BRAF inhibitor therapy (n = 7). Enrolled diagnoses were one each of histiocytosis, ameloblastoma, Ewing sarcoma, and high-grade glioma, all with BRAF V600E mutations. Treatment was overall tolerable with mostly expected grade 1/2 adverse events (AE). Grade 3 or 4 AE on treatment were acute kidney injury, hyperglycemia, and maculopapular rash. One patient came off therapy due to AE. One patient (glioma) had an objective partial response and remained on protocol therapy for 15 cycles.

conclusionThere was a low accrual rate on this MATCH subprotocol, with only 18% of those who matched with BRAFV600 mutations enrolling, resulting in early termination, and limiting study results (ClinicalTrials.gov Identifier: NCT03220035).

Indexed as

MutationProto-Oncogene Proteins B-rafVemurafenibAdolescentAdultChildChild, PreschoolFemaleHumansMaleNeoplasmsYoung AdultBRAF protein, humanProto-Oncogene Proteins B-rafVemurafenibBRAF V600 mutationspediatric matchvemurafenib

Identifiers

PMID38873934
PMCPMC11299954

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.