Evidence map›Paper›PMID 34006498›Full record

Trial reportClinical genitourinary cancer2021

A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and Pembrolizumab Combination Therapy in Patients with Advanced Renal Cell Carcinoma.

Simon Chowdhury, Jeffery R Infante, Robert Hawkins, Martin H Voss, Rodolfo Perini, Tobias Arkenau, Mark Voskoboynik, Paola Aimone, Isabelle Naeije, Albert Reising and 1 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical genitourinary cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 8% 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

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
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  4. Camrelizumab Plus Apatinib in Patients With Advanced Cervical Cancer (CLAP): A Multicenter, Open-Label, Single-Arm, Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
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  6. Angiosarcoma: Role of Immunotherapy.Current treatment options in oncology · 2025
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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

11 authors at 10 institutions in 4 countries.

Simon ChowdhurySarah Cannon Research Institute, London, United Kingdom; Guy's Hospital, London, United Kingdom.
Jeffery R InfanteSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
Robert HawkinsInstitute of Cancer Sciences, Manchester, United Kingdom.
Martin H VossMemorial Sloan-Kettering Cancer Center, New York, New York.
Rodolfo PeriniMerck & Co., Inc., Kenilworth, NJ.
Tobias ArkenauSarah Cannon Research Institute and Cancer Institute, University College, London, United Kingdom.
Mark VoskoboynikAlfred Health Melbourne, Monash University, Melbourne, Australia.
Paola AimoneNovartis Pharma AG, Basel, Switzerland.
Isabelle NaeijeNovartis Pharma AG, Basel, Switzerland.
Albert ReisingNovartis Oncology, East Hanover, NJ.
David F McDermottBeth Israel Deaconess Medical Center, Boston, MA. Electronic address: dmcdermo@bidmc.harvard.edu.
Novartis (Switzerland) · CHAlfred Health · AUBeth Israel Deaconess Medical Center · USCancer Research UK Manchester Institute · GBGuy's Hospital · GBMemorial Sloan Kettering Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USNovartis (United States) · USSarah Cannon · USSarah Cannon Research Institute · GB

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

backgroundThis study assessed whether antiangiogenic treatment may potentiate immune checkpoint blockade in patients with advanced renal cell carcinoma. PATIENTS AND

methodsThis was an open-label, two-part, multicenter study involving treatment-naïve patients with advanced renal cell carcinoma. Part 1 consisted of a phase I dose escalation and expansion of pazopanib plus pembrolizumab (combination therapy). Cohorts A and B received pazopanib in combination with pembrolizumab, whereas Cohort C received pazopanib monotherapy for 9 weeks before receiving the combination therapy. Part 2 was planned as a randomized three-arm study but was not conducted.

resultsOverall, 42 patients were enrolled (10 each in Cohorts A and B, 22 in Cohort C). The maximum tolerated dose was not reached and the recommended phase II dose was not declared, as Cohort C was closed early because of safety concerns. The overall response rates were 60% and 20% in Cohorts A and B, respectively. In Cohort C, the overall response rates were 33%, 25%, and 0% in the combination therapy, pembrolizumab monotherapy, and pazopanib monotherapy groups, respectively. The median progression-free survival rates were 21.95 months and 41.40 months in Cohorts A and B, respectively. Grade 3 or 4 adverse events (AEs) were observed in 90% of patients in Cohorts A and B. In Cohort C, the frequencies of grade 3 or 4 AEs, serious adverse events, and AEs leading to dose reduction were typically high in the combination therapy group.

conclusionsDespite preliminary signs of efficacy, significant hepatotoxicity was observed in Cohorts A and B. The sequential schedule of pazopanib followed by pazopanib plus pembrolizumab showed reduced hepatotoxicity; however, other safety issues emerged with this approach.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansIndazolesPyrimidinesSulfonamidesTreatment OutcomeAntibodies, Monoclonal, HumanizedIndazolespazopanibpembrolizumabPyrimidinesSulfonamidesAntiangiogenicImmune checkpoint inhibitorImmuno-oncologyTKI/IOVEGF-TKI

Identifiers

PMID34006498
PMCPMC9494291
OpenAlexW3154072571

What OpenQuestion holds

Textmetadata
LicenceTDM
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.