Evidence map›Paper›PMID 30567529›Full record

Trial reportBMC cancer2018

A phase II trial of recombinant MAGE-A3 protein with immunostimulant AS15 in combination with high-dose Interleukin-2 (HDIL2) induction therapy in metastatic melanoma.

Jennifer L McQuade, Jade Homsi, Carlos A Torres-Cabala, Roland Bassett, Rashmi Murthy Popuri, Marihella L James, Luis M Vence, Wen-Jen Hwu

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

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01266603 (A Phase II Trial of High Dose Interleukin-2), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT01266603 phase2completednot on this map

A Phase II Trial of High Dose Interleukin-2 (HDIL-2) With Recombinant MAGE-A3 Protein Combined With Adjuvant System AS15 (recMAGE-A3 + AS15) in Patients With Unresectable or Metastatic Melanoma

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2011 to 2018Enrolled44ConditionsMelanomaArmsHDIL-2, recMAGE-A3 + AS15
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 37 citations in OpenAlex.

  1. Review
  2. Review
  3. TLR9: A Double-Dealing Toll-Like Receptor.ImmunoTargets and therapy · 2025
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Peptide-based vaccine for cancer therapies.Frontiers in immunology · 2023
    Review
  11. Targeted Cancer Immunotherapy: Nanoformulation Engineering and Clinical Translation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2022
    Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Clinical translation of immunomodulatory therapeutics.Advanced drug delivery reviews · 2021
    Review
  18. Review
  19. Article
  20. 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

8 authors at 2 institutions in 1 country.

Jennifer L McQuadeDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe, Unit 0430, Houston, TX, 77030, USA. jmcquade@mdanderson.org.ORCID http://orcid.org/0000-0002-2393-2172
Jade HomsiDivision of Hematology/Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Carlos A Torres-CabalaDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Roland BassettDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rashmi Murthy PopuriDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe, Unit 0430, Houston, TX, 77030, USA.
Marihella L JamesDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe, Unit 0430, Houston, TX, 77030, USA.
Luis M VenceDepartment of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Wen-Jen HwuDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe, Unit 0430, Houston, TX, 77030, USA.
The University of Texas MD Anderson Cancer Center · USThe University of Texas Southwestern Medical Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
TRAINING FOR ACADEMIC ONCOLOGY/HEMATOLOGYT32CA009666 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Michael Davies, Courtney DiNardo · 1994 to 2026
$9.8M
NCI NIH HHS P30 CA016672NCI NIH HHS T32 CA009666NIH HHS CA009666
6 · The paper itself

Abstract

backgroundHDIL-2 is approved for advanced melanoma based on its durable antitumor activity. MAGE-A3 cancer immunotherapeutic (MAGE-A3 CI) is a recombinant MAGE-A3 protein combined with an immunostimulant adjuvant system and has shown antitumor activity in melanoma. We assessed the safety and anti-tumor activity of HDIL-2 combined with MAGE-A3 CI in advanced melanoma.

methodsPatients with unresectable Stage III or Stage IV MAGE-A3-positive melanoma were enrolled in this phase II study. Treatment included an induction phase of MAGE-A3 CI plus HDIL-2 for 8 cycles followed by a maintenance phase of MAGE-A3 CI monotherapy. The primary endpoints were safety and objective response assessed per RECIST v1.1. Immune biomarker and correlative studies on tumor and peripheral blood were performed.

resultsEighteen patients were enrolled. Seventeen patients were evaluable for safety and sixteen for response. Responses occurred in 4/16 (25%) patients with 3 complete responses, and stable disease in 6/16 (38%) patients with a disease control rate of 63%. The median duration of response was not reached at median follow-up of 36.8 months. Induction therapy of HDIL-2 + MAGE-A3 CI had similar toxicities to those reported with HDIL-2 alone. Maintenance MAGE-A3 monotherapy was well-tolerated. Increased immune checkpoint receptor expression by circulating T regulatory cells was associated with poor clinical outcomes; and responders tended to have increased tumor infiltrating T cells in the baseline tumor samples.

conclusionsThe safety profile of HDIL-2 + MAGE-A3 CI was similar to HDIL-2 monotherapy. Maintenance MAGE-A3 CI provides robust anti-tumor activity in patients who achieved disease control with induction therapy. Immune monitoring data suggest that MAGE-A3 CI plus checkpoint inhibitors could be a promising treatment for MAGE-A3-positive melanoma.

trial registrationClinicalTrials.gov, NCT01266603 . Registered 12/24/2010, https://clinicaltrials.gov/ct2/show/NCT01266603.

Indexed as

Adjuvants, ImmunologicAdultAntigens, NeoplasmFemaleHumansImmunotherapyInterleukin-2MaleMelanomaMiddle AgedNeoplasm ProteinsNeoplasm StagingRecombinant ProteinsT-Lymphocytes, RegulatoryTreatment OutcomeAdjuvants, ImmunologicAntigens, NeoplasmInterleukin-2MAGEA3 protein, humanNeoplasm ProteinsRecombinant ProteinsHDIL-2ImmunotherapyMAGE-A3 CIMelanoma

Identifiers

PMID30567529
PMCPMC6300080
OpenAlexW2904428181

What OpenQuestion holds

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LicenceCC BY
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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.