Evidence map›Paper›PMID 32097091›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Phase Ib/II Clinical Trial of Pembrolizumab With Bevacizumab for Metastatic Renal Cell Carcinoma: BTCRC-GU14-003.

Arkadiusz Z Dudek, Li C Liu, Shilpa Gupta, Theodore F Logan, Eric A Singer, Monika Joshi, Yousef N Zakharia, Joshua M Lang, James K Schwarz, Anas Al-Janadi and 1 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 4% 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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  13. Endoplasmic Reticulum Stress in Renal Cell Carcinoma.International journal of molecular sciences · 2023
    Review
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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 1 country.

Arkadiusz Z DudekDivision of Hematology/Oncology, Department of Medicine, University of Illinois at Chicago, Chicago, IL.
Li C LiuDivision of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL.
Shilpa GuptaDivision of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN.
Theodore F LoganIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN.
Eric A SingerRutgers Cancer Institute of New Jersey, New Brunswick, NJ.
Monika JoshiPenn State Cancer Institute, Pennsylvania State University, State College, PA.
Yousef N ZakhariaUniversity of Iowa Hospitals and Clinics, University of Iowa, Iowa City, IA.
Joshua M LangCarbone Cancer Center, University of Wisconsin, Madison, WI.
James K SchwarzFred & Pamela Buffett Cancer Center, Omaha, NE.
Anas Al-JanadiMSU Breslin Cancer Center, Michigan State University, Lansing, MI.
Ajjai S AlvaRogel Cancer Center, University of Michigan, Ann Arbor, MI.
University of Illinois Chicago · USFred and Pamela Buffett Cancer CenterIndiana University Health · USMichigan State University · USPennsylvania State University · USRutgers Cancer Institute of New JerseyUniversity of Iowa Hospitals and Clinics · USUniversity of Michigan–Ann Arbor · USUniversity of Minnesota · USUniversity of Wisconsin Carbone Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe hypothesized that bevacizumab will potentiate activity of pembrolizumab. We conducted a phase Ib/II, single-arm, multisite clinical trial of the combination in metastatic renal cell carcinoma (RCC). PATIENTS AND

methodsPatients with metastatic clear cell RCC who experienced progression after at least one systemic therapy (phase Ib) or were treatment naïve (phase II) were enrolled. In phase Ib, pembrolizumab (200 mg) and bevacizumab (10 or 15 mg/kg) were given intravenously every 3 weeks. The primary end point for phase II was overall response rate (ORR). With an 80% statistical power and a type I error probability of 0.1, 48 patients were to be accrued to detect an ORR of 42%.

resultsThirteen patients (ages 33-68 years; median, 55 years) were enrolled in the phase Ib study. No dose-limiting toxicities were reported. Pembrolizumab 200 mg and bevacizumab 15 mg/kg were chosen for phase II. Forty-eight patients (ages 42-84 years; median age, 61 years; 33 males) were accrued for the phase II study. The primary end point was met, with the ORR reaching 60.9% (95% CI, 45.4% to 74.9%), consisting of 1 complete response (CR), 2 CRs in target lesions, 25 partial responses, 18 responses of stable disease, 2 unevaluable responses. Median progression-free survival was 20.7 months (95% CI, 11.3 to 27.4 months). Median overall survival was not reached at the median follow-up of 28.3 months. The most common treatment-related grade 3 toxicities were hypertension and proteinuria. There were two grade 4 toxicities: duodenal ulcer and hyponatremia. Presence of tumor-infiltrating T cells, but not programmed death-ligand 1 expression, in tumor tissue correlated with response.

conclusionThe combination of 200 mg of pembrolizumab and a 15 mg/kg dose of bevacizumab given every 3 weeks is safe and active in metastatic RCC.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Renal CellFemaleHumansKidney NeoplasmsMaleMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedBevacizumabpembrolizumab

Identifiers

PMID32097091
PMCPMC7145584
OpenAlexW3007061204

What OpenQuestion holds

Textmetadata
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.