Evidence map›Paper›PMID 38365756›Full record

Trial reportNature communications2024

Neoadjuvant cobimetinib and atezolizumab with or without vemurafenib for high-risk operable Stage III melanoma: the Phase II NeoACTIVATE trial.

Tina J Hieken, Garth D Nelson, Thomas J Flotte, Eric P Grewal, Jun Chen, Robert R McWilliams, Lisa A Kottschade, Lu Yang, Evidio Domingo-Musibay, Roxana S Dronca and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03554083 (Neoadjuvant Therapy for Patients With High Risk Stage III Melanoma), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 3% of its field
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.

NCT03554083 phase2completednot on this map

Neoadjuvant Therapy for Patients With High Risk Stage III Melanoma: A Pilot Clinical Trial

TypeinterventionalSponsorMayo ClinicRan2018 to 2025Enrolled64ConditionsClinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8ArmsAtezolizumab, Cobimetinib, Tiragolumab, Vemurafenib
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
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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

24 authors at 5 institutions in 1 country.

Tina J HiekenDivision of Breast and Melanoma Surgical Oncology, Department of Surgery, Mayo Clinic, Rochester, MN, USA.
Garth D NelsonDepartment of Quantitative Health Sciences, Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN, USA.
Thomas J FlotteDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0001-5691-8249
Eric P GrewalDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-2189-7975
Jun ChenDepartment of Quantitative Health Sciences, Computational Biology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-1273-5624
Robert R McWilliamsDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-8199-5040
Lisa A KottschadeDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.
Lu YangDepartment of Quantitative Health Sciences, Computational Biology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-5234-3190
Evidio Domingo-MusibayDivision of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0002-2082-554X
Roxana S DroncaDivision of Hematology and Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA.
Yiyi YanDivision of Hematology and Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA.
Svetomir N MarkovicDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.
Anastasios DimouDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-3950-3305
Heather N MontaneDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.
Courtney L ErskineDepartment of Immunology, Mayo Clinic, Rochester, MN, USA.
Mara A PiltinDivision of Breast and Melanoma Surgical Oncology, Department of Surgery, Mayo Clinic, Rochester, MN, USA.
Daniel L PriceDepartment of Otolaryngology, Mayo Clinic, Rochester, MN, USA.
Samir S KhariwalaDepartment of Otolaryngology, University of Minnesota, Minneapolis, MN, USA.
Jane HuiDivision of Surgical Oncology, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0002-2628-0720
Carrie A StrandDepartment of Quantitative Health Sciences, Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN, USA.
Susan M HarringtonDepartment of Immunology, Mayo Clinic, Rochester, MN, USA.
Vera J SumanDepartment of Quantitative Health Sciences, Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-9640-5189
Haidong DongDepartment of Immunology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-5782-2983
Matthew S BlockDepartment of Oncology, Mayo Clinic, Rochester, MN, USA. block.matthew@mayo.edu.ORCID 0000-0001-5692-4219
Mayo Clinic in Arizona · USMayo Clinic · USMayo Clinic in Florida · USUniversity of Minnesota · USWinnMed · US

Funding

Biomedical Data Translator Technical Feasibility Assessment and Architecture DesignOT3TR002020 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI AHALT, STANLEY CARLTON, TROPSHA, ALEXANDER · 2016 to 2019
$3.1M
EIF | Stand Up To Cancer (SU2C) SU2C-AACR-CT10-17Mayo Clinic | Center for Clinical and Translational Science, Mayo Clinic (CCaTS) 92541640-2020
6 · The paper itself

Abstract

Both targeted therapies and immunotherapies provide benefit in resected Stage III melanoma. We hypothesized that the combination of targeted and immunotherapy given prior to therapeutic lymph node dissection (TLND) would be tolerable and drive robust pathologic responses. In NeoACTIVATE (NCT03554083), a Phase II trial, patients with clinically evident resectable Stage III melanoma received either 12 weeks of neoadjuvant vemurafenib, cobimetinib, and atezolizumab (BRAF-mutated, Cohort A, n = 15), or cobimetinib and atezolizumab (BRAF-wild-type, Cohort B, n = 15) followed by TLND and 24 weeks of adjuvant atezolizumab. Here, we report outcomes from the neoadjuvant portion of the trial. Based on intent to treat analysis, pathologic response (≤50% viable tumor) and major pathologic response (complete or near-complete, ≤10% viable tumor) were observed in 86.7% and 66.7% of BRAF-mutated and 53.3% and 33.3% of BRAF-wild-type patients, respectively (primary outcome); these exceeded pre-specified benchmarks of 50% and 30% for major pathologic response. Grade 3 and higher toxicities, primarily dermatologic, occurred in 63% during neoadjuvant treatment (secondary outcome). No surgical delays nor progression to regional unresectability occurred (secondary outcome). Peripheral blood CD8 + T

Indexed as

Antibodies, Monoclonal, HumanizedAzetidinesMelanomaPiperidinesSkin NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansMutationNeoadjuvant TherapyProto-Oncogene Proteins B-rafVemurafenibAntibodies, Monoclonal, HumanizedatezolizumabAzetidinescobimetinibPiperidinesProto-Oncogene Proteins B-rafVemurafenib

Identifiers

PMID38365756
PMCPMC10873383
OpenAlexW4391879604

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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.