Evidence map›Paper›PMID 34737281›Full record

Trial reportNature communications2021

Pilot study of Tremelimumab with and without cryoablation in patients with metastatic renal cell carcinoma.

Matthew T Campbell, Surena F Matin, Alda L Tam, Rahul A Sheth, Kamran Ahrar, Rebecca S Tidwell, Priya Rao, Jose A Karam, Christopher G Wood, Nizar M Tannir and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02626130 (A Pilot Study of Tremelimumab With or Without Tissue Cryoablation in Patients With Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
3.4field-weighted citation impact, top 5% 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.

NCT02626130 early_phase1completednot on this map

A Pilot Study of Tremelimumab With or Without Tissue Cryoablation in Patients With Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2016 to 2022Enrolled29ConditionsClear Cell Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Stage IV Renal Cell Cancer AJCC v7ArmsCryosurgery, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery, Tremelimumab
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 60 citations in OpenAlex.

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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

22 authors at 1 institution in 1 country.

Matthew T CampbellDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA.ORCID 0000-0003-1915-4491
Surena F MatinDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-1638-1445
Alda L TamDepartment of Interventional Radiology, The University of Texas of MD Anderson Cancer Center, Houston, TX, USA.
Rahul A ShethDepartment of Interventional Radiology, The University of Texas of MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-9615-8985
Kamran AhrarDepartment of Interventional Radiology, The University of Texas of MD Anderson Cancer Center, Houston, TX, USA.
Rebecca S TidwellDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-3041-8582
Priya RaoDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jose A KaramDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-7697-9591
Christopher G WoodDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nizar M TannirDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA.
Eric JonaschDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA.ORCID 0000-0003-0943-2806
Jianjun GaoDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA.ORCID 0000-0001-6138-4472
Amado J ZuritaDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA.
Amishi Y ShahDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA.ORCID 0000-0002-9007-0621
Sonali JindalThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Fei DuanThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sreyashi BasuThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-5028-3833
Hong ChenThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alexsandra B EspejoThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-8841-7219
James P AllisonThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shalini S YadavThe Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Padmanee SharmaDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson, Houston, TX, USA. padsharma@mdanderson.org.ORCID 0000-0003-4658-055X
The University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cryoablation in combination with immune checkpoint therapy was previously reported to improve anti-tumor immune responses in pre-clinical studies. Here we report a pilot study of anti-CTLA-4 (tremelimumab) with (n = 15) or without (n = 14) cryoablation in patients with metastatic renal cell carcinoma (NCT02626130), 18 patients with clear cell and 11 patients with non-clear cell histologies. The primary endpoint is safety, secondary endpoints include objective response rate, progression-free survival, and immune monitoring studies. Safety data indicate ≥ grade 3 treatment-related adverse events in 16 of 29 patients (55%) including 6 diarrhea/colitis, 3 hepatitis, 1 pneumonitis, and 1 glomerulonephritis. Toxicity leading to treatment discontinuation occurs in 5 patients in each arm. 3 patients with clear cell histology experience durable responses. One patient in the tremelimumab arm experiences an objective response, the median progression-free survival for all patients is 3.3 months (95% CI: 2.0, 5.3 months). Exploratory immune monitoring analysis of baseline and post-treatment tumor tissue samples shows that treatment increases immune cell infiltration and tertiary lymphoid structures in clear cell but not in non-clear cell. In clear cell, cryoablation plus tremelimumab leads to a significant increase in immune cell infiltration. These data highlight that treatment with tremelimumab plus cryotherapy is feasible and modulates the immune microenvironment in patients with metastatic clear cell histology.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Renal CellCombined Modality TherapyCryosurgeryCTLA-4 AntigenFemaleHumansKidney NeoplasmsMaleMiddle AgedNeoplasm MetastasisPatient SafetyAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCTLA-4 AntigenCTLA4 protein, humantremelimumab

Identifiers

PMID34737281
PMCPMC8569213
OpenAlexW3208093894

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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.