Evidence map›Paper›PMID 41968073›Full record

Trial reportThe oncologist2026

Phase 2 study of cabozantinib (XL184) with nivolumab and ipilimumab for the treatment of poorly differentiated neuroendocrine carcinomas (ETCTN10315).

Adel Mandl, Ruizhe Chen, Satya Das, Jonathan R Strosberg, Anup Kasi, Bhavana Konda, Daneng Li, Timothy F Burns, Aman Chauhan, Kristen K Ciombor and 11 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04079712 (A Phase 2 Study of XL184), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04079712 phase2active not recruitingnot on this map

A Phase 2 Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2020 to 2026Enrolled17ConditionsMetastatic Large Cell Neuroendocrine Carcinoma, Metastatic Neuroendocrine Carcinoma, Metastatic Neuroendocrine Neoplasm, Metastatic Small Cell Neuroendocrine CarcinomaArmsCabozantinib S-malate, Ipilimumab, Nivolumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

21 authors.

Adel MandlDepartment of Oncology, Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Ruizhe ChenDepartment of Oncology, Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Satya DasVanderbilt University Medical Center, Nashville, TN, USA.
Jonathan R StrosbergH. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.
Anup KasiUniversity of Kansas Cancer Center, Kansas City, KS, USA.
Bhavana KondaThe Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute, Columbus, OH, USA.ORCID 0000-0002-9099-5990
Daneng LiCity of Hope National Medical Center, Duarte, CA, USA.ORCID 0000-0001-5330-7522
Timothy F BurnsUPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Aman ChauhanSylvester Comprehensive Cancer Center, University of Miami, FL, USA.
Kristen K CiomborVanderbilt University Medical Center, Nashville, TN, USA.
Farshid DayyaniChao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA, USA.
Tanya DorffCity of Hope National Medical Center, Duarte, CA, USA.ORCID 0000-0001-5990-298X
James P OhrUPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Bhaumik B PatelVCU Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA.
Vineeth SukrithanThe Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute, Columbus, OH, USA.ORCID 0000-0002-5878-9900
Heloisa P SoaresHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
Kang ChenBarbara Ann Karmanos Cancer Institute, Wayne State University School of Medicine, Obstetrics and Gynecology, Detroit, MI, USA.
Stephen V LiuGeorgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.ORCID 0000-0002-4852-3914
Anteneh A TesfayeGeorgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
Michael A CarducciDepartment of Oncology, Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.ORCID 0000-0002-7908-1215
Jan H BeumerDepartment of Oncology, Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.ORCID 0000-0002-8978-9401

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
NCI ET-CTN with Phase i Emphasis at UPCIUM1CA186690 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD, Farshid Dayyani · 2014 to 2026
$9.1M
HHSNCI NIH HHS P30CA006973NCI NIH HHS UM1 CA186690NCI NIH HHS UM1 CA186691NCI NIH HHS UM1CA186691NCI NIH HHS UM1CA186712NCI NIH HHS UM1 CA186717U.S. Government
6 · The paper itself

Abstract

backgroundPoorly differentiated neuroendocrine carcinomas (NECs) are aggressive malignancies with limited treatment options. The low activity of immune checkpoint inhibitors (ICI) is in part due to an immunosuppressive tumor microenvironment. We hypothesized that adding cabozantinib to dual ICIs may improve clinical outcomes for patients.

methodsPatients with advanced or metastatic, poorly differentiated NECs, excluding small cell lung and Merkel cell carcinoma, who progressed on first-line systemic therapy enrolled on this Simon's two-stage trial. Patients received cabozantinib 40 mg daily, 3 mg/kg nivolumab plus 1 mg/kg ipilimumab every 3 weeks for four cycles, followed by maintenance cabozantinib nivolumab. The primary endpoint was ORR.

resultsOf 17 patients enrolled, 16 were evaluable. ORR was 12.5% (2/16; 95%CI: 1.6%-38.3%), with 2 durable (27 and 17 months). Median PFS was 2.7 months (95%CI: 1.8-5.6 months). Grade 3-4 treatment-related adverse events occurred in 9 patients (56%). The most frequent grade ≥3 toxicities were elevated liver enzymes, fatigue, and hypertension. Only one patient discontinued treatment due to toxicity. The study was terminated after the first stage, as it did not meet the threshold for proceeding to stage 2.

conclusionToxicities were consistent with the known safety profiles of cabozantinib and dual immune checkpoint blockade. Long-term responses were observed in a small subset of patients, but the study did not meet the prespecified efficacy threshold for continued accrual. CLINICALTRIALS.GOV IDENTIFIER: NCT04079712.

Indexed as

AnilidesAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, NeuroendocrineIpilimumabNivolumabPyridinesAdultAgedFemaleHumansMaleMiddle AgedAnilidescabozantinibIpilimumabNivolumabPyridinescabozantinibcheckpoint inhibitorsimmunotherapyipilimumabneuroendocrine carcinomanivolumabtyrosine kinase inhibitor

Identifiers

PMID41968073
PMCPMC13181262

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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.