Evidence map›Paper›PMID 40158923›Full record

Trial reportEuropean urology oncology2025

A Phase 1b/2 Study of Talazoparib and Axitinib in Patients with Advanced Clear-cell Renal Cell Carcinoma.

Ritesh R Kotecha, Sahil D Doshi, Andrea Knezevic, Rachel Jacobi, Hyung Jun Woo, David H Aggen, Deaglan J McHugh, Neil J Shah, Maria I Carlo, Niamh M Keegan and 8 more

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

Trial report in European urology 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 NCT04337970 (A Phase Ib/II Study of Talazoparib and Axitinib in Metastatic Renal Cell Carcinoma), 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.

NCT04337970 phase1 / phase2completednot on this map

A Phase Ib/II Study of Talazoparib and Axitinib in Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2020 to 2025Enrolled23ConditionsKidney Cancer, Renal Cell Carcinoma, Unresectable Renal Cell Carcinoma, Metastatic Renal Cell CarcinomaArmsTalazoparib, Axitinib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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.

Ritesh R KotechaDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA. Electronic address: kotechar@mskcc.org.
Sahil D DoshiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Andrea KnezevicDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Rachel JacobiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Hyung Jun WooMarie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
David H AggenDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Deaglan J McHughDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Neil J ShahDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Maria I CarloDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Niamh M KeeganDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Yogini GayadinDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Joshua ChaimDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Mark T A DonoghueMarie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Gopa IyerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Chung-Han LeeDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Darren R FeldmanDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Robert J MotzerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA.
Martin H VossDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weil Cornell Medical College, New York, NY, USA. Electronic address: vossm@mskcc.org.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Inactivation of the VHL gene leads to HIF accumulation, angiogenesis, and genomic instability. In this phase 1b/2 study, we assessed the safety and antitumor activity of axitinib combined with talazoparib in treatment-refractory clear-cell renal cell carcinoma (ccRCC). Patients received escalating doses of talazoparib with a fixed standard dose of axitinib in a 3 + 3 design. This was followed by a dose expansion phase in a separate cohort. The primary endpoints were determination of the recommended phase 2 dose (RP2D) and the objective response rate. From 2020 to 2023, 23 patients with ccRCC were enrolled: 15 in the dose escalation cohort and eight in the dose expansion cohort. The RP2D was identified as talazoparib 1 mg daily with axitinib 5 mg twice daily. At the RP2D, 13/14 patients discontinued treatment because of disease progression. Median progression-free survival was 6.1 mo (95% confidence interval 3.5-8.4). Thirteen patients (56%) experienced at least one grade 3+ treatment-emergent adverse event (AE), while nine (39%) experienced at least one treatment-related grade ≥3 AE, of which diarrhea, nausea, and anemia were the most common. This is the first report on a VEGFR-targeted tyrosine kinase inhibitor combined with a PARP inhibitor for ccRCC. While our results demonstrate the safety of this strategy, the combination did not meet a predefined efficacy threshold for continued evaluation. This trial is registered on Clinicaltrials.gov as NCT04337970.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAxitinibCarcinoma, Renal CellKidney NeoplasmsPhthalazinesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedAxitinibPhthalazinestalazoparibAxitinibRenal cell carcinomaTalazoparib

Identifiers

PMID40158923
PMCPMC13191573

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.