Evidence map›Paper›PMID 38954785›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Final Results From a Phase I Trial and Expansion Cohorts of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced/Metastatic Genitourinary Tumors.

Andrea B Apolo, Daniel M Girardi, Scot A Niglio, Rosa Nadal, Andre R Kydd, Nicholas Simon, Lisa Ley, Lisa M Cordes, Elias Chandran, Seth M Steinberg and 30 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02496208 (A Phase 1 Study of Cabozantinib Plus Nivolumab), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT02496208 phase1active not recruitingnot on this map

A Phase 1 Study of Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2015 to 2026Enrolled152ConditionsBladder Small Cell Neuroendocrine Carcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Clear Cell Renal Cell CarcinomaArmsBiopsy Procedure, Biospecimen Collection, Cabozantinib S-malate, Computed Tomography, Echocardiography Test
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Trial
  2. Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Inflammation in Penile Squamous Cell Carcinoma: A Comprehensive Review.International journal of molecular sciences · 2025
    Review
  11. Review
  12. Article
  13. Emerging Therapies in Penile Cancer.Frontiers in oncology · 2022
    Review
  14. Review
  15. Review
  16. 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

40 authors.

Andrea B ApoloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0001-9409-1836
Daniel M GirardiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-7903-8217
Scot A NiglioGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Rosa NadalGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-6836-9731
Andre R KyddGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-5579-8457
Nicholas SimonGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0003-1259-9201
Lisa LeyGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Lisa M CordesGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0003-3833-4084
Elias ChandranGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-0150-7765
Seth M SteinbergBiostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-8280-551X
Sunmin LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Min-Jung LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Shraddha RastogiDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0003-0680-0407
Nahoko SatoDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0009-0007-1772-3183
Liang CaoMolecular Targets Core, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0001-7293-8338
A Rouf BandayGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Salah BoudjadiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Maria J MerinoLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Antoun ToubajiLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Dilara AkbulutLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Bernadette ReddRadiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD.ORCID 0000-0001-9058-9485
Hadi BagheriRadiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD.
Rene CostelloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Sandeep GurramUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-6405-9269
Piyush K AgarwalUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Heather J ChalfinUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Vladimir ValeraUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Howard StreicherInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville, MD.
John Joseph WrightInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville, MD.
Elad SharonInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville, MD.ORCID 0000-0002-0044-9719
William D FiggGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0003-2428-5613
Howard L ParnesDivision of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0003-3401-0007
James L GulleyCenter for Onco-Immunology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-6569-2912
Biren SaraiyaGenitourinary Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.
Sumanta K PalCity of Hope Comprehensive Cancer Center, Duarte, CA.ORCID 0000-0002-1712-0848
David QuinnDivision of Cancer Medicine and Blood Diseases, Department of Medicine, Genitourinary Oncology, Keck School of Medicine, University of Southern California, Los Angeles, CA.ORCID 0000-0002-1411-0417
Mark N SteinGenitourinary Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY.ORCID 0000-0002-0853-3640
Primo N LaraUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA.ORCID 0000-0001-9512-0002
Donald P BottaroUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-5057-5334
Amir MortazaviDivision of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, and the Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0002-2122-6805

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
Anatomic Pathology Residency ProgramZIEBC011384 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BARR, FREDERIC · 2011 to 2025
$26.8M
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
Sample Processing and Analytical Methods Development for New Anticancer AgentsZICSC006536 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$18.1M
Drug Development for Prostate Cancer and other Metastatic ProcessesZIABC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$10.2M
Targeting the MET Pathway in Urothelial CarcinomaZIABC011594 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2014 to 2025
$7.9M
Investigating mechanisms of bladder tumorigenesis and therapeutic resistanceZIABC012091 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BANDAY, ABDUL · 2022 to 2025
$5.5M
Rare GU tumors projectsZIABC011928 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2019 to 2025
$4.6M
Development Therapeutics Branch-Translational Medicine and Therapeutics GroupZICBC012174 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI THOMAS, ANISH · 2024 to 2025
$1.8M
NCI NIH HHS P30 CA093373NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

purposeCabozantinib and nivolumab (CaboNivo) alone or with ipilimumab (CaboNivoIpi) have shown promising efficacy and safety in patients with metastatic urothelial carcinoma (mUC), metastatic renal cell carcinoma (mRCC), and rare genitourinary (GU) tumors in a dose-escalation phase I study. We report the final data analysis of the safety, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) of the phase I patients and seven expansion cohorts.

methodsThis is an investigator-initiated, multicenter, phase I trial. CaboNivo doublet expansion cohorts included (1) mUC, (2) mRCC, and (3) adenocarcinoma of the bladder/urachal; CaboNivoIpi triplet expansion cohorts included (1) mUC, (2) mRCC, (3) penile cancer, and (4) squamous cell carcinoma of the bladder and other rare GU tumors (ClinicalTrials.gov identifier: NCT02496208).

resultsThe study enrolled 120 patients treated with CaboNivo (n = 64) or CaboNivoIpi (n = 56), with a median follow-up of 49.2 months. In 108 evaluable patients (CaboNivo n = 59; CaboNivoIpi n = 49), the ORR was 38% (complete response rate 11%) and the median duration of response was 20 months. The ORR was 42.4% for mUC, 62.5% for mRCC (n = 16), 85.7% for squamous cell carcinoma of the bladder (n = 7), 44.4% for penile cancer (n = 9), and 50.0% for renal medullary carcinoma (n = 2). Grade ≥ 3 treatment-related adverse events occurred in 84% of CaboNivo patients and 80% of CaboNivoIpi patients.

conclusionCaboNivo and CaboNivoIpi demonstrated clinical activity and safety in patients with multiple GU malignancies, especially clear cell RCC, urothelial carcinoma, and rare GU tumors such as squamous cell carcinoma of the bladder, small cell carcinoma of the bladder, adenocarcinoma of the bladder, renal medullary carcinoma, and penile cancer.

Indexed as

AnilidesAntineoplastic Combined Chemotherapy ProtocolsIpilimumabNivolumabPyridinesUrogenital NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgression-Free SurvivalAnilidescabozantinibIpilimumabNivolumabPyridines

Identifiers

PMID38954785
PMCPMC11361361

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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.