Evidence map›Paper›PMID 39133806›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

Cabozantinib Plus Ipilimumab/Nivolumab in Patients With Previously Treated Advanced Differentiated Thyroid Cancer.

Bhavana Konda, Eric J Sherman, Erminia Massarelli, Jorge Nieva, Jameel Muzaffar, John C Morris, Mabel Ryder, Alan L Ho, Mark Agulnik, Lai Wei and 7 more

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

Trial report in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03914300 (Phase II Study of XL184), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03914300 phase2active not recruitingnot on this map

Phase II Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab (CaboNivoIpi) in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Whose Cancer Progressed After One Prior VEGFR-Targeted Therapy

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2020 to 2026Enrolled11ConditionsDifferentiated Thyroid Gland Carcinoma, Follicular Variant Thyroid Gland Papillary Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Refractory Differentiated Thyroid Gland CarcinomaArmsBiospecimen Collection, Cabozantinib S-malate, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Bhavana KondaDivision of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.ORCID 0000-0002-9099-5990
Eric J ShermanDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Erminia MassarelliDepartment of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA.
Jorge NievaDepartment of Medicine, University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, CA 90033, USA.
Jameel MuzaffarDivision of Medical Oncology, Duke Cancer Institute, Duke University, Durham, NC 27710, USA.
John C MorrisDepartments of Endocrinology & Medical Oncology, Mayo Clinic Comprehensive Cancer Center, Rochester, MN 55905, USA.
Mabel RyderDepartments of Endocrinology & Medical Oncology, Mayo Clinic Comprehensive Cancer Center, Rochester, MN 55905, USA.
Alan L HoDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Mark AgulnikDepartment of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA.
Lai WeiDepartment of Biostatistics, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
Demond HandleyDepartment of Biostatistics, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
Catherine MosesDivision of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
Rajani JacobDivision of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
John WrightInvestigational Drug Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Howard StreicherInvestigational Drug Branch, National Cancer Institute, Bethesda, MD 20892, USA.ORCID 0000-0003-3683-9804
William CarsonDivision of Surgical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
Manisha H ShahDivision of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
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
Princess Margaret Phase I Consorium (PMP1C)UM1CA186644 · NCI · UNIVERSITY HEALTH NETWORK · PI Philippe Bedard, Kevin D Courtney · 2014 to 2026
$16.6M
Phase 2 Clinical Trials Program for Experimental Therapeutics Clinical Trials NetworkUM1CA186686 · NCI · MAYO CLINIC ROCHESTER · PI ADJEI, ALEX A. · 2014 to 2019
$5.3M
City of Hope Cancer Center 4UM1CA186717-07Mayo Clinic, Rochester 3UM1CA186686-03S1Memorial Sloan Kettering UM1CA186691Moffitt Cancer Center 2UM1 CA186644-06NCI NIH HHS P30 CA008748NCI NIH HHS UM1 CA186644NCI NIH HHS UM1 CA186686NCI NIH HHS UM1 CA186691NCI NIH HHS UM1 CA186712NCI NIH HHS UM1 CA186717The Ohio State University Comprehensive Cancer Center 5UM1CA186712-03University of Southern California UM1CA186717
6 · The paper itself

Abstract

backgroundThis investigator-initiated phase II trial aimed to evaluate the efficacy of cabozantinib in combination with nivolumab and ipilimumab (CaboNivoIpi) in previously treated patients with radioactive iodine-refractory differentiated thyroid cancer.

methodsEligible patients with radioactive iodine-refractory differentiated thyroid cancer who progressed on 1 prior line of vascular endothelial growth factor receptor-targeted therapy received a 2-week run-in of cabozantinib monotherapy followed by CaboNivoIpi for 4 cycles (cycle length = 6 weeks), followed by cabozantinib plus nivolumab (cycle length = 4 weeks) until disease progression. The primary endpoint was objective response rate (ORR) within the first 6 months of treatment. A Simon optimal 2-stage design allowed for an interim analysis after accrual of 10 evaluable patients. At least 5 responses were needed to proceed to stage 2.

resultsAmong 11 patients enrolled, the median age was 69 years. Prior vascular endothelial growth factor receptor-targeted therapies included lenvatinib, pazopanib, and sorafenib plus everolimus. Median follow-up was 7.9 months. Among 10 evaluable patients, ORR within the first 6 months of treatment was 10% (1 partial response). Median progression-free survival was 9 months (95% CI, 3.0-not reached) and median overall survival was 19.2 months (95% CI, 4.6-not reached). Grade 3/4 treatment-related adverse events (AEs) were noted in 55% (6/11) and grade 5 AEs in 18% (2/11) of patients. The most common treatment-related AE was hypertension. The study did not reach its prespecified efficacy threshold.

conclusionCaboNivoIpi had low ORRs and a high rate of grade ≥3 treatment-related AEs. CLINICAL

trial registrationNCT03914300.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsThyroid NeoplasmsAdultAgedAged, 80 and overAnilidesFemaleFollow-Up StudiesHumansIpilimumabMaleMiddle AgedNivolumabPyridinesAnilidescabozantinibIpilimumabNivolumabPyridinescabozantinibdifferentiated thyroid cancerimmune checkpoint inhibitorsipilimumabnivolumabVEGFR

Identifiers

PMID39133806
PMCPMC11834700

What OpenQuestion holds

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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.