Evidence map›Paper›PMID 38252910›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Nivolumab + Tacrolimus + Prednisone ± Ipilimumab for Kidney Transplant Recipients With Advanced Cutaneous Cancers.

Kara M Schenk, Julie Stein Deutsch, Sunandana Chandra, Diwakar Davar, Zeynep Eroglu, Nikhil I Khushalani, Jason J Luke, Patrick A Ott, Jeffrey A Sosman, Vikram Aggarwal and 16 more

Open access · greenAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
11.9field-weighted citation impact, top 1% 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

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Guideline
  2. The Immune Checkpoint Inhibitors Journey: From Early Promise to Lasting Impact.Journal of immunotherapy and precision oncology · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
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

26 authors at 8 institutions in 1 country.

Kara M SchenkDepartment of Oncology, Bozeman Health Deaconess Cancer Center, Bozeman, MT.ORCID 0000-0001-5147-8301
Julie Stein DeutschDepartment of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD.
Sunandana ChandraRobert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.ORCID 0000-0001-7936-5069
Diwakar DavarDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA.ORCID 0000-0002-7846-8055
Zeynep ErogluDepartment of Cutaneous Oncology, The Moffitt Cancer Center and Research Institute, Tampa, FL.ORCID 0000-0002-2307-7030
Nikhil I KhushalaniDepartment of Cutaneous Oncology, The Moffitt Cancer Center and Research Institute, Tampa, FL.ORCID 0000-0002-3636-4143
Jason J LukeCancer Immunotherapeutics Center, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA.ORCID 0000-0002-1182-4908
Patrick A OttDana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA.
Jeffrey A SosmanRobert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.
Vikram AggarwalDivision of Nephrology and Hypertension, Northwestern University Feinberg School of Medicine, Chicago, IL.
Megan D SchollenbergerDepartment of Oncology, Johns Hopkins University, Baltimore, MD.
William H SharfmanDepartment of Oncology, Johns Hopkins University, Baltimore, MD.ORCID 0000-0001-7766-249X
Kristin P BibeeDepartment of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-7851-9633
Jeffrey F ScottDepartment of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD.
Manisha J LossDepartment of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0001-6990-4209
Hao WangBloomberg-Kimmel Institute for Cancer Immunotherapy and Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Hanfei QiDivision of Quantitative Sciences, Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD.ORCID 0000-0002-0072-5752
Elad SharonNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, MD.ORCID 0000-0002-0044-9719
Howard StreicherNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, MD.
Helen X ChenNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, MD.
Robert N WoodwardCareDx, Brisbane, CA.ORCID 0000-0001-7514-498X
Serena M BagnascoDepartment of Pathology, Johns Hopkins University School of Medicine and Johns Hopkins Hospital, Baltimore, MD.
Janis M TaubeDepartment of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-8273-4395
Suzanne L TopalianBloomberg-Kimmel Institute for Cancer Immunotherapy and Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-0821-8587
Daniel C BrennanDepartment of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-4818-7455
Evan J LipsonDepartment of Oncology, Johns Hopkins University, Baltimore, MD.ORCID 0000-0003-2976-0911
Johns Hopkins University · USBloomberg (United States) · USNational Cancer Institute · USNorthwestern University · USMoffitt Cancer Center · USUPMC Hillman Cancer Center · USBrigham and Women's Hospital · USPAX Scientific (United States) · US

Funding

The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
NCI ET-CTN with Phase i Emphasis at UPCIUM1CA186690 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD, Farshid Dayyani · 2014 to 2026
$9.1M
NCI NIH HHS UM1 CA186690NCI NIH HHS UM1 CA186691
6 · The paper itself

Abstract

purposeCancer-related mortality rates among kidney transplant recipients (KTR) are high, but these patients have largely been excluded from trials of immune checkpoint inhibitors because of immunosuppression and risk of treatment-related allograft loss (TRAL). We conducted a prospective clinical trial testing nivolumab (NIVO) + tacrolimus (TACRO) + prednisone (PRED) ± ipilimumab (IPI) in KTR with advanced cutaneous cancers.

methodsAdult KTR with advanced melanoma or basal, cutaneous squamous, or Merkel cell carcinomas were eligible. Immunosuppression was standardized to TACRO (serum trough 2-5 ng/mL) + PRED 5 mg once daily. Patients then received NIVO 480 mg IV once every 4 weeks. The primary composite end point was partial or complete (tumor) response (CR) or stable disease per RECIST v1.1 without allograft loss at 16W. Patients with progressive disease (PD) could receive IPI 1 mg/kg IV + NIVO 3 mg/kg once every 3 weeks × 4 followed by NIVO. Donor-derived cell-free DNA (dd-cfDNA) levels were measured approximately once every 2 weeks as a potential predictor of allograft rejection.

resultsAmong eight evaluable patients, none met the trial's primary end point. All eight patients experienced PD on NIVO + TACRO + PRED; TRAL occurred in one patient. Six patients then received IPI + NIVO + TACRO + PRED. Best overall responses: two CR (one with TRAL) and four PD (one with TRAL). In total, 7 of 8 pre-NIVO tumor biopsies contained a paucity of infiltrating immune cells. In total, 2 of 5 on-NIVO biopsies demonstrated moderate immune infiltrates; both patients later experienced a CR to IPI + NIVO. In 2 of 3 patients with TRAL, dd-cfDNA elevations occurred 10 and 15 days before increases in serum creatinine.

conclusionIn most KTR with advanced skin cancer, TACRO + PRED provides insufficient allograft protection and compromises immune-mediated tumor regression after administration of NIVO ± IPI. Elevated dd-cfDNA levels can signal treatment-related allograft rejection earlier than rises in serum creatinine.

Indexed as

Cell-Free Nucleic AcidsKidney NeoplasmsKidney TransplantationMelanomaAdultAntineoplastic Combined Chemotherapy ProtocolsCreatinineHumansIpilimumabNivolumabPrednisoneProspective StudiesTacrolimusCell-Free Nucleic AcidsCreatinineIpilimumabNivolumabPrednisoneTacrolimus

Identifiers

PMID38252910
PMCPMC11677297
OpenAlexW4391091487

What OpenQuestion holds

Textmetadata
LicenceTDM
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.