Evidence map›Paper›PMID 40753466›Full record

ArticleCancer2025

Intratumoral vidutolimod as monotherapy or in combination with pembrolizumab in patients with programmed cell death 1 blockade-resistant melanoma: Final analysis from a phase 1b study.

Mohammed M Milhem, Yousef Zakharia, Diwakar Davar, Elizabeth I Buchbinder, Theresa Medina, Adil Daud, Antoni Ribas, Bartosz Chmielowski, Jiaxin Niu, Geoffrey T Gibney and 13 more

Erratum issuedAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Mohammed M MilhemUniversity of Iowa, Iowa City, Iowa, USA.
Yousef ZakhariaUniversity of Iowa, Iowa City, Iowa, USA.
Diwakar DavarUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Elizabeth I BuchbinderDana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-7979-8953
Theresa MedinaUniversity of Colorado Denver, Aurora, Colorado, USA.
Adil DaudUniversity of California San Francisco, San Francisco, California, USA.ORCID https://orcid.org/0000-0002-6617-8421
Antoni RibasJonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, California, USA.
Bartosz ChmielowskiJonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, California, USA.
Jiaxin NiuBanner MD Anderson Cancer Center, Gilbert, Arizona, USA.
Geoffrey T GibneyLombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, Washington, DC, USA.
Kim MargolinSaint John's Cancer Institute, Santa Monica, California, USA.ORCID https://orcid.org/0000-0002-5248-4356
Anthony J OlszanskiFox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
Inderjit MehmiThe Angeles Clinic and Research Institute, Cedars-Sinai Affiliate, Los Angeles, California, USA.
Takami SatoThomas Jefferson University, Philadelphia, Pennsylvania, USA.
Montaser ShaheenThe University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Luping ZhaoCheckmate Pharmaceuticals, Cambridge, Massachusetts, USA.
Heather KelleyCheckmate Pharmaceuticals, Cambridge, Massachusetts, USA.
Hong LiuCheckmate Pharmaceuticals, Cambridge, Massachusetts, USA.
Sujatha KumarCheckmate Pharmaceuticals, Cambridge, Massachusetts, USA.
Dmitri BobilevFusion Pharmaceuticals, Boston, Massachusetts, USA.
Arthur M KriegZola Therapeutics, Needham, Massachusetts, USA.
James E WooldridgeCheckmate Pharmaceuticals, Cambridge, Massachusetts, USA.
John M KirkwoodHillman Cancer Center, University of Pittsburgh Medical Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-3570-4476

Funding

Next Generation Cancer Immunotherapies to Defeat MelanomaR35CA197633 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ANTONI RIBAS · 2015 to 2026
$10.4M
Checkmate PharmaceuticalsNCI NIH HHS R35 CA197633
6 · The paper itself

Abstract

backgroundNew treatment options are needed for patients with metastatic anti-programmed cell death 1 (PD-1)-resistant melanoma. The final analysis of a phase 1b study evaluating the Toll-like receptor 9 agonist vidutolimod is reported here.

methodsThis two-part, open-label, multicenter, phase 1b study in adults with metastatic/unresectable anti-PD-1-resistant melanoma evaluated the safety and clinical activity of intratumoral vidutolimod plus systemic pembrolizumab (part 1) or vidutolimod alone (part 2). Two vidutolimod formulations were evaluated with different concentrations of polysorbate (PS20-A, 0.005%-0.01% polysorbate 20; PS20-B, 0.00167% polysorbate 20). Key end points were safety and investigator-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors, version 1.1).

resultsA total of 159 patients were treated in part 1 (PS20-A, n = 98; PS20-B, n = 61), and 40 patients were treated in part 2. Any-grade treatment-emergent adverse events (TEAEs) occurred in 100.0% of patients. Grade ≥3 TEAEs occurred in 55.3% (part 1) and 37.5% (part 2) of patients. No treatment-related deaths occurred. Best ORR was 23.5% (95% CI, 15.5%-33.1%; complete response [CR], 7.1%) for vidutolimod PS20-A plus pembrolizumab, 11.5% (95% CI, 4.7%-22.2%; CR, 1.6%) for vidutolimod PS20-B plus pembrolizumab, and 20.0% (95% CI, 9.1%-35.6%) for vidutolimod monotherapy. Median duration of response was 25.2 months with vidutolimod PS20-A plus pembrolizumab, 11.4 months with vidutolimod PS20-B plus pembrolizumab, and 5.6 months with vidutolimod monotherapy.

conclusionsVidutolimod PS20-A alone or in combination with pembrolizumab had an acceptable safety profile and promising clinical activity in patients with PD-1 blockade-resistant melanoma.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsMelanomaSkin NeoplasmsAdultAgedAged, 80 and overDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedProgrammed Cell Death 1 ReceptorAntibodies, Monoclonal, HumanizedPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 ReceptorCMP‐001immunotherapymelanomapembrolizumabphase 1bToll‐like receptor 9 (TLR9) agonistvidutolimod

Identifiers

PMID40753466
PMCPMC12318270

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.