Evidence map›Paper›PMID 39965176›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

COSMIC-021 Phase Ib Study of Cabozantinib Plus Atezolizumab: Results from the Locally Advanced or Metastatic Urothelial Carcinoma Cohorts.

Sumanta K Pal, Yohann Loriot, Andrea Necchi, Parminder Singh, Daniel Castellano, Lance Pagliaro, Cristina Suarez, Bradley A McGregor, Ulka N Vaishampayan, Ralph J Hauke and 8 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, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03170960 (A Phase 1b Dose-Escalation Study of Cabozantinib), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03170960 phase1active not recruitingnot on this map

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

TypeinterventionalSponsorExelixisRan2017 to 2027Enrolled914ConditionsUrothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate CancerArmscabozantinib, atezolizumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

18 authors.

Sumanta K PalCity of Hope Comprehensive Cancer Center, Duarte, CA.ORCID 0000-0002-1712-0848
Yohann LoriotDITEP, Gustave Roussy, Université Paris-Saclay, Villejuif, France.ORCID 0000-0002-8338-1739
Andrea NecchiDepartment of Medical Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, Milan, Italy.ORCID 0000-0002-3007-2756
Parminder SinghDepartment of Oncology, Mayo Clinic, Phoenix, AZ.ORCID 0000-0002-8548-6948
Daniel CastellanoHospital Universitario 12 de Octubre, Madrid, Spain.ORCID 0000-0002-9106-0687
Lance PagliaroDepartment of Oncology, Mayo Clinic, Rochester, MN.
Cristina SuarezMedical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID 0000-0002-0502-5528
Bradley A McGregorDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-8298-0289
Ulka N VaishampayanUniversity of Michigan, Ann Arbor, MI.ORCID 0000-0001-5800-4571
Ralph J HaukeNebraska Cancer Specialists-Midwest Cancer Center, Omaha, NE.ORCID 0000-0002-0243-7279
Thomas PowlesBarts Health NHS Trust Saint Bartholomew's Hospital, London, United Kingdom.ORCID 0000-0001-7760-4724
Carla M L Van HerpenRadboud Universitair Medisch Centrum, Nijmegen, the Netherlands.ORCID 0000-0001-5130-5451
Kevin D CourtneyUniversity of Texas Southwestern Medical Center, Dallas, TX.ORCID 0000-0001-6273-3144
Robert DreicerUniversity of Virginia Cancer Center, Charlottesville, VA.ORCID 0000-0002-0552-6912
Ramu SudhagoniExelixis, Inc, Alameda, CA.
Martin SchwickartExelixis, Inc, Alameda, CA.
Svetlana AndrianovaExelixis, Inc, Alameda, CA.
Neeraj AgarwalHuntsman Cancer Institute, University of Utah, Salt Lake City, UT.ORCID 0000-0003-1076-0428

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

purposeThe COSMIC-021 study assessed the safety and efficacy of cabozantinib plus atezolizumab in advanced solid tumors. Presented here are results from the expansion cohorts with advanced urothelial carcinoma (UC).

methodsThis phase Ib study (ClinicalTrials.gov identifier: NCT03170960) enrolled patients with inoperable locally advanced/metastatic UC into four tumor cohorts: first-line cisplatin-eligible (cis-eligible), first-line cisplatin-ineligible (cis-ineligible), previous platinum-containing chemotherapy (previous chemotherapy-treated), and previous immune checkpoint inhibitor (ICI)-treated. Patients received oral cabozantinib 40 mg once daily and intravenous atezolizumab 1,200 mg once every 3 weeks. The primary end point was objective response rate (ORR), as assessed by the investigator per RECIST v1.1 every 6 weeks for 12 months and every 12 weeks thereafter; the secondary end point was safety.

resultsA total of 121 patients (previous ICI-treated cohort, n = 31, and each of the other cohorts, n = 30) received study treatment from March 2018 to November 2021. The ORR (95% CI) was 30% (15 to 49) for cis-eligible, 20% (8 to 39) for cis-ineligible, 27% (12 to 46) for previous chemotherapy-treated, and 10% (2 to 26) for previous ICI-treated cohorts. The median progression-free survival (95% CI) was 5.5 (1.6 to 11.6), 5.6 (3.1 to 11.1), 5.4 (1.6 to 7.6), and 3.0 (1.8 to 5.5) months, respectively. Grade 3 or 4 treatment-related adverse events (TRAEs) were experienced by 43%, 67%, 57%, and 45% of patients, respectively. TRAEs led to discontinuation of all treatment components in 17%, 13%, 3%, and 19%, respectively. No grade 5 TRAEs were reported in any cohort.

conclusionThe novel combination of cabozantinib plus atezolizumab exhibited clinical activity in advanced UC that is cis-eligible, cis-ineligible, or previously treated with platinum-containing chemotherapy; clinical activity in previous ICI-treated UC was modest. The toxicity profile was consistent with that previously reported for the combination.

Indexed as

AnilidesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellPyridinesUrologic NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm MetastasisAnilidesAntibodies, Monoclonal, HumanizedatezolizumabcabozantinibPyridines

Identifiers

PMID39965176
PMCPMC12058374

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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.