Evidence map›Paper›PMID 38767650›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024

Early On-Treatment Assessment of T Cells, Cytokines, and Tumor DNA with Adaptively Dosed Nivolumab + Ipilimumab: Final Results from the Phase 2 ADAPT-IT Study.

James W Smithy, Hannah L Kalvin, Fiona D Ehrich, Ronak Shah, Matthew Adamow, Vladislav Raber, Collen A Maher, Jenna Kleman, Deborah A G McIntyre, Alexander N Shoushtari and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03122522 (A Phase II Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT03122522 phase2active not recruitingnot on this map

A Phase II Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2017 to 2027Enrolled70ConditionsMetastatic MelanomaArmsipilimumab, nivolumab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Advances in Cancer Immunotherapy for Solid Tumors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. 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

20 authors.

James W SmithyMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-3126-1193
Hannah L KalvinMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-6636-0602
Fiona D EhrichMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-2245-9352
Ronak ShahMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-9042-6213
Matthew AdamowMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-7709-0126
Vladislav RaberMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0009-0001-7891-8570
Collen A MaherMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-1117-9272
Jenna KlemanMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0009-0007-1115-0257
Deborah A G McIntyreMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-8079-4124
Alexander N ShoushtariMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-8065-4412
Allison Betof WarnerMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-6422-2997
Margaret K CallahanMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-9087-0012
Parisa MomtazMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-3030-7615
Omar EtonHartford HealthCare Cancer Institute, Hartford, Connecticut.ORCID 0000-0002-9141-553X
Suresh NairLehigh Valley Health Network, Allentown, Pennsylvania.ORCID 0000-0001-7763-9732
Jedd D WolchokMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-6718-2222
Paul B ChapmanMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-1618-0811
Michael F BergerMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-3882-5000
Katherine S PanageasMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-6591-604X
Michael A PostowMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-3367-7961

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Bristol-Myers Squibb (BMS)National Cancer Institute (NCI) P30CA008748NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThe Adaptively Dosed ImmunoTherapy Trial (ADAPT-IT;NCT03122522) investigated adaptive ipilimumab discontinuation in melanoma based on early radiographic assessment. Initial findings indicated similar effectiveness compared with conventional nivolumab-ipilimumab (nivo-ipi). Exploratory biomarker analyses and final clinical results are now reported. PATIENTS AND

methodsPatients with unresectable melanoma received two doses of nivo-ipi. Radiographic assessment at Week 6 informed continuation of ipilimumab before nivolumab maintenance. The primary endpoint was overall response rate at Week 12. Plasma was assayed for circulating tumor DNA and 10 cytokines using a multiplex immunoassay. Flow cytometry of peripheral blood mononuclear cells was performed with an 11-color panel.

resultsAmong the treated patients, expansion of proliferating T-cell populations was observed in responders and nonresponders. Baseline IL6 levels were low in patients achieving an objective radiographic response (median 1.30 vs. 2.86 pg/mL; P = 0.025). High baseline IL6 levels were associated with short progression-free survival [PFS; HR = 1.24, 95% confidence interval (CI), 1.01-1.52; P = 0.041]. At Week 6, patients with response had lower average tumor variant allele fractions than nonresponders (median 0.000 vs. 0.019; P = 0.014). Greater increases in average variant allele fractions from baseline to Week 6 correlated with short PFS (HR = 1.11, 95% CI, 1.01-1.21; P = 0.023). Week 12 overall response rate was 47% (95% CI, 35%-59%) with a median follow-up of 34 months among survivors. Median PFS was 21 months (95% CI, 10-not reached); 76% of responses (95% CI, 64%-91%) persisted at 36 months.

conclusionsAdaptively dosed nivo-ipi responses are durable and resemble historical data for conventional nivo-ipi. Baseline IL6 and circulating tumor DNA changes during treatment warrant further study as biomarkers of nivo-ipi response.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCytokinesIpilimumabMelanomaNivolumabAdultAgedAged, 80 and overBiomarkers, TumorCirculating Tumor DNADNA, NeoplasmFemaleHumansMaleMiddle AgedT-LymphocytesBiomarkers, TumorCirculating Tumor DNACytokinesDNA, NeoplasmIpilimumabNivolumab

Identifiers

PMID38767650
PMCPMC11357703

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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.