Evidence map›Paper›PMID 37962072›Full record

ArticleCancer2024

Assessment of the safety of nivolumab in people living with HIV with advanced cancer on antiretroviral therapy: the AIDS Malignancy Consortium 095 Study.

Lakshmi Rajdev, Chia-Ching Jackie Wang, Himanshu Joshi, Shelly Lensing, Jeannette Lee, Juan Carlos Ramos, Robert Baiocchi, Lee Ratner, Paul G Rubinstein, Richard Ambinder and 10 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02408861 (A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV Associated Solid Tumors With Expansion Cohort in HIV Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT02408861 phase1terminatednot on this map

A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV Associated Solid Tumors With Expansion Cohort in HIV Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2015 to 2024Enrolled79ConditionsAdvanced Malignant Solid Neoplasm, Anal Carcinoma, HIV Infection, Kaposi SarcomaArmsBiospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Ipilimumab, Nivolumab
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. The Immune Checkpoint Inhibitors Journey: From Early Promise to Lasting Impact.Journal of immunotherapy and precision oncology · 2026
    Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Cancer Immunotherapy Trials Network 12: Pembrolizumab in HIV-Associated Kaposi Sarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  10. Article
  11. Review
  12. Observational
  13. 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

20 authors at 16 institutions in 1 country.

Lakshmi RajdevTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Chia-Ching Jackie WangUCSF Helen Diller Comprehensive Cancer Center, San Francisco, California, USA.
Himanshu JoshiTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID 0000-0003-0272-0733
Shelly LensingSt. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Jeannette LeeUniversity of Arkansas for Medical Sciences, Little Rock, Alaska, USA.
Juan Carlos RamosUniversity of Miami Sylvester Cancer Center, Miami, Florida, USA.
Robert BaiocchiOhio State University James Comprehensive Cancer Center, Columbus, Ohio, USA.
Lee RatnerWashington University, St. Louis, Missouri, USA.
Paul G RubinsteinDivision of Hematology/Oncology, Stroger Hospital of Cook County (Cook County Hospital), Ruth M. Rothstein Core Center, University of Illinois, Chicago, Illinois, USA.ORCID 0000-0002-0724-461X
Richard AmbinderJohns Hopkins Univ-Sidney Kimmel Cancer Center, Baltimore, Maryland, USA.
David HenryPennsylvania Hospital, Philadelphia, Pennsylvania, USA.
Howard StreicherDivision of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health, Bethesda, Maryland, USA.
Richard F LittleDivision of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-4091-1699
Elizabeth ChiaoMD Anderson Cancer Center, Houston, Texas, USA.
Dirk P DittmerUniversity of North Carolina, Chapel Hill, North Carolina, USA.ORCID 0000-0003-4968-5656
Mark H EinsteinRutgers New Jersey Medical School, Newark, New Jersey, USA.
Ethel CesarmanWeill Cornell Medicine, New York, New York, USA.
Ronald MitsuyasuUniversity of California Los Angeles Care Center, Los Angeles, California, USA.
Joseph A SparanoTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID 0000-0002-9031-2010
AIDS Malignancy Consortium
Icahn School of Medicine at Mount Sinai · USNational Institutes of Health · USCornell University · USJohn H. Stroger, Jr. Hospital of Cook County · USPennsylvania Hospital · USRutgers, The State University of New Jersey · USSidney Kimmel Cancer Center · USSt. Jude Children's Research Hospital · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe University of Texas MD Anderson Cancer Center · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Arkansas for Medical Sciences · USUniversity of California, Los Angeles · USUniversity of Miami · USUniversity of North Carolina at Chapel Hill · USWashington University in St. Louis · US

Funding

Consortium for Advancing Management and Prevention of Cancer in People with HIVUM1CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Joseph A. Sparano · 2015 to 2026
$253.7M
Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
University of Southern CaliforniaU01CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MITSUYASU, RONALD T. · 2006 to 2014
$54.7M
Vironomics and Biostatistics CoreP01CA019014 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BLOSSOM A DAMANIA, NANCY JOAN RAAB-TRAUB · 1985 to 2026
$43.8M
Targeted Therapies for HIV-Associated Kaposi Sarcoma and LymphomaR01CA163217 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BLOSSOM A DAMANIA, Dirk P Dittmer · 2011 to 2026
$5.5M
Impact of HIV on the Tumor MicroenvironmentR01CA228172 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAMANIA, BLOSSOM A, DITTMER, DIRK P · 2018 to 2022
$2.0M
NCI NIH HHS P01 CA019014NCI NIH HHS P30 CA016086NCI NIH HHS R01 CA163217NCI NIH HHS R01 CA228172NCI NIH HHS U01 CA121947NCI NIH HHS UM1 CA121947NCI NIH HHS UM1CA121947
6 · The paper itself

Abstract

backgroundAlthough immunotherapy has emerged as a therapeutic strategy for many cancers, there are limited studies establishing the safety and efficacy in people living with HIV (PLWH) and cancer.

methodsPLWH and solid tumors or Kaposi sarcoma (KS) receiving antiretroviral therapy and a suppressed HIV viral load received nivolumab at 3 mg/kg every 2 weeks, in two dose deescalation cohorts stratified by CD4 count (stratum 1: CD4 count > 200/µL and stratum 2: CD4 count 100-199/µL). An expansion cohort of 24 participants with a CD4 count > 200/µL was then enrolled.

resultsA total of 36 PLWH received nivolumab, including 15 with KS and 21 with a variety of other solid tumors. None of the first 12 participants had dose-limiting toxicity in both CD4 strata, and five patients (14%) overall had grade 3 or higher immune related adverse events. Objective partial response occurred in nine PLWH and cancer (25%), including in six of 15 with KS (40%; 95% CI, 16.3-64.7). The median duration of response was 9.0 months overall and 12.5 months in KS. Responses were observed regardless of PDL1 expression. There were no significant changes in CD4 count or HIV viral load.

conclusionsNivolumab has a safety profile in PLWH similar to HIV-negative subjects with cancer, and also efficacy in KS. Plasma HIV remained suppressed and CD4 counts remained stable during treatment and antiretroviral therapy, indicating no adverse impact on immune function.

trial registrationClinicalTrials.gov Identifier: NCT02408861.

Indexed as

Acquired Immunodeficiency SyndromeHIV InfectionsSarcoma, KaposiCD4 Lymphocyte CountHumansNivolumabViral LoadNivolumabCD4 count >100/µLHIV cancerimmunotherapynivolumab

Identifiers

PMID37962072
PMCPMC10922055
OpenAlexW4388656798

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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.