Evidence map›Paper›PMID 32915679›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors.

Andrea B Apolo, Rosa Nadal, Daniel M Girardi, Scot A Niglio, Lisa Ley, Lisa M Cordes, Seth M Steinberg, Olena Sierra Ortiz, Jacqueline Cadena, Carlos Diaz and 25 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
19.6field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 136 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Switch Maintenance Therapy for Metastatic Urothelial Carcinoma.Bladder cancer (Amsterdam, Netherlands) · 2022
    Pooled it
  4. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Triplet Strategies in Metastatic Clear Cell Renal Cell Carcinoma: A Worthy Option in the First-Line Setting?American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023
    Trial
  11. Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  12. Trial
  13. Trial
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  15. Trial
  16. Review
  17. Article
  18. Tumor-infiltrating plasma cells are a prognostic factor in penile squamous cell carcinoma.Virchows Archiv : an international journal of pathology · 2025
    Article
  19. Review
  20. Review

18 more citing papers are in PubMed but not listed here.

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

35 authors at 6 institutions in 1 country.

Andrea B ApoloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0001-9409-1836
Rosa NadalGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-6836-9731
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.
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.
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
Olena Sierra OrtizGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Jacqueline CadenaGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Carlos DiazGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Marissa MallekGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Nicole N DavarpanahGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0003-3948-5319
Rene CostelloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Jane B TrepelDevelopmental 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.
Maria J MerinoLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Mohammad Hadi BagheriClinical Image Processing Service, Clinical Center, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-9273-5359
Paul MonkDivision of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, and the Comprehensive Cancer Center, Columbus, OH.
William D FiggGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
James L GulleyGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-6569-2912
Piyush K AgarwalUrologic 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.
Heather J ChalfinUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Jennifer JonesLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-9488-7719
Howard StreicherInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville, MD.
John J WrightInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville, MD.
Yangmin M NingGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Howard L ParnesDivision of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD.
William L DahutGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-2766-9703
Donald P BottaroUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-5057-5334
Primo N LaraUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA.
Biren SaraiyaRutgers Cancer Institute of New Jersey, New Brunswick, NJ.
Sumanta K PalCity of Hope Comprehensive Cancer Center, Duarte, CA.ORCID 0000-0002-1712-0848
Mark N SteinRutgers Cancer Institute of New Jersey, New Brunswick, NJ.
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
National Institutes of Health · USRutgers, The State University of New Jersey · USThe Ohio State University · USCity of Hope · USNational Institutes of Health Clinical Center · USUC Davis Comprehensive Cancer Center

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
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
Bladder Cancer ProgramZIABC011351 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2010 to 2025
$9.4M
Intramural NIH HHS ZIA BC011351NCI NIH HHS P30 CA093373NCI NIH HHS UM1 CA186712NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

purposeWe assessed the safety and efficacy of cabozantinib and nivolumab (CaboNivo) and CaboNivo plus ipilimumab (CaboNivoIpi) in patients with metastatic urothelial carcinoma (mUC) and other genitourinary (GU) malignances. PATIENTS AND

methodsPatients received escalating doses of CaboNivo or CaboNivoIpi. The primary objective was to establish a recommended phase II dose (RP2D). Secondary objectives included objective response rate (ORR), progression-free survival (PFS), duration of response (DoR), and overall survival (OS).

resultsFifty-four patients were enrolled at eight dose levels with a median follow-up time of 44.6 months; data cutoff was January 20, 2020. Grade 3 or 4 treatment-related adverse events (AEs) occurred in 75% and 87% of patients treated with CaboNivo and CaboNivoIpi, respectively, and included fatigue (17% and 10%, respectively), diarrhea (4% and 7%, respectively), and hypertension (21% and 10%, respectively); grade 3 or 4 immune-related AEs included hepatitis (0% and 13%, respectively) and colitis (0% and 7%, respectively). The RP2D was cabozantinib 40 mg/d plus nivolumab 3 mg/kg for CaboNivo and cabozantinib 40 mg/d, nivolumab 3 mg/kg, and ipilimumab 1 mg/kg for CaboNivoIpi. ORR was 30.6% (95% CI, 20.0% to 47.5%) for all patients and 38.5% (95% CI, 13.9% to 68.4%) for patients with mUC. Median DoR was 21.0 months (95% CI, 5.4 to 24.1 months) for all patients and not reached for patients with mUC. Median PFS was 5.1 months (95% CI, 3.5 to 6.9 months) for all patients and 12.8 months (95% CI, 1.8 to 24.1 months) for patients with mUC. Median OS was 12.6 months (95% CI, 6.9 to 18.8 months) for all patients and 25.4 months (95% CI, 5.7 to 41.6 months) for patients with mUC.

conclusionCaboNivo and CaboNivoIpi demonstrated manageable toxicities with durable responses and encouraging survival in patients with mUC and other GU tumors. Multiple phase II and III trials are ongoing for these combinations.

Indexed as

AdultAgedAged, 80 and overAnilidesAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarcinoma, Transitional CellColitisDiarrheaEpithelial Cell Adhesion MoleculeFatigueFemaleHepatitisHumansHypertensionIpilimumabAnilidesB7-H1 AntigencabozantinibCD274 protein, humanCXCR4 protein, humanEPCAM protein, humanEpithelial Cell Adhesion MoleculeIpilimumabMET protein, humanNivolumabProto-Oncogene Proteins c-metPyridinesReceptors, CXCR4

Identifiers

PMID32915679
PMCPMC7605393
OpenAlexW3086850485

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.