Evidence map›Paper›PMID 39576210›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

A Phase II Open-Label, Randomized Clinical Trial of Atezolizumab with or without Human Recombinant IL-7 (CYT107) in Advanced Urothelial Cancer.

Randy F Sweis, Gurkamal S Chatta, Rohit K Jain, Helen Moon, Scott Edward Delacroix, Alana Fang, Leonard D'Amico, Angela Shaulov Kask, Martin A Cheever, Steven Fling and 5 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. 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

15 authors.

Randy F SweisSection of Hematology and Oncology, Department of Medicine, University of Chicago, Chicago, Illinois.ORCID 0000-0002-0497-9637
Gurkamal S ChattaRoswell Park Comprehensive Cancer Center, Buffalo, New York.ORCID 0000-0002-3154-9042
Rohit K JainMoffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-9295-9360
Helen MoonSCPMG-Kaiser, Riverside, California.ORCID 0009-0007-6303-5285
Scott Edward DelacroixLouisiana State University School of Medicine and Stanley S. Scott Cancer Ctr, New Orleans, Louisiana.ORCID 0000-0001-8291-409X
Alana FangCytel, Inc., Beijing, China.ORCID 0009-0000-7993-7370
Leonard D'AmicoFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0000-0002-1143-7297
Angela Shaulov KaskFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0009-0001-4175-7339
Martin A CheeverFred Hutchinson Cancer Center, Seattle, Washington.
Steven FlingFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0000-0001-6263-0153
Elad SharonNational Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-0044-9719
Andreanne LacroixFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0009-0005-5358-8922
Judith C KaiserFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0000-0001-7165-7200
Russell K PachynskiDivision of Oncology, Washington University Medical School, St. Louis, Missouri.ORCID 0000-0002-8966-7631
Evan Y YuFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0000-0002-1510-8044

Funding

Cancer Immunotherapy Trials Network Central Operations and Statistical CenterUM1CA154967 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DAVIDSON, NANCY ELLEN · 2017 to 2022
$20.7M
Cancer Immunotherapy Trials Network Central Operations and Statistical CenterU01CA154967 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI CHEEVER, MARTIN ALEXANDER · 2010 to 2017
$16.8M
Multiscale Computational Models Guided By Emerging Cellular Dynamics Quantification For Predicting Optimum Immune Checkpoint And Targeted Therapy SchedulesU01CA243075 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI JACKSON, TRACHETTE · 2020 to 2024
$2.6M
Elucidating immunotherapy resistance mechanisms in non-T cell-inflamed bladder cancerK08CA234392 · NCI · UNIVERSITY OF CHICAGO · PI SWEIS, RANDY F. · 2018 to 2021
$851k
National Cancer Institute (NCI) K08CA234392NCI NIH HHS K08 CA234392NCI NIH HHS U01 CA154967NCI NIH HHS U01 CA243075NCI NIH HHS UM1 CA154967
6 · The paper itself

Abstract

purposeAdvanced urothelial cancer generally has high mortality despite modern anti-PD-1/L1 antibody-based combinations. Augmenting checkpoint inhibitor-mediated immune responses with lymphocyte growth factors may improve outcomes. We conducted a randomized phase II study (Cancer Immunotherapy Trials Network-14) in 47 patients to explore whether human recombinant IL-7 (CYT107) could be safely combined with PD-L1 inhibition to enhance responses. PATIENTS AND

methodsPatients with urothelial cancer after platinum chemotherapy were randomized to atezolizumab alone or with CYT107 weekly for four doses. The primary objective was clinical efficacy by the objective response rate (ORR). Secondary objectives included safety, toxicity, and other clinical outcomes. Correlative endpoints included peripheral immunophenotyping and quantification of cytokines.

resultsCYT107 plus atezolizumab was well-tolerated, without dose-limiting toxicities and lower grade 3 to 4 treatment-related adverse events compared with atezolizumab monotherapy. The ORR was 26.3% for the combination therapy versus 23.8% for atezolizumab alone (P = 0.428). The complete response rate was 10.5% for the combination therapy versus 4.8% for monotherapy. Three patients on combination therapy had responses >21 months versus one with monotherapy. CD4+ and CD8+ T-lymphocyte expansion occurred in patients with response to combination therapy, with the greatest effect in T memory stem cells. Patients who responded to treatment exhibited elevated baseline levels of CCL4 and reduced levels of VEGFA and TNF.

conclusionsCombining CYT107 with atezolizumab was safe and resulted in lymphocyte expansion, a doubling of the complete response rate, and durable responses exceeding 2 years. However, the ORR was similar to atezolizumab alone. Increased and sustained doses of CYT107 coupled with patient selection strategies should be further investigated.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsInterleukin-7Urologic NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedRecombinant ProteinsTreatment OutcomeAntibodies, Monoclonal, HumanizedatezolizumabIL7 protein, humanInterleukin-7Recombinant Proteins

Identifiers

PMID39576210
PMCPMC11747792

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Registered trials

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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.