Evidence map›Paper›PMID 38038862›Full record

Trial reportInvestigational new drugs2024

Phase I/II trial of BMS-986,205 and nivolumab as first line therapy in hepatocellular carcinoma.

Jasmine C Huynh, May Cho, Arta Monjazeb, Ebaa Al-Obeidi, Amisha Singh, Kit Tam, Frances Lara, Anthony Martinez, Leslie Garcia, Edward J Kim

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Investigational new drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

10 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
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  4. Article
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  7. Harnessing IDO inhibitors to optimize cancer immunotherapy.Naunyn-Schmiedeberg's archives of pharmacology · 2025
    Review
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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

10 authors at 3 institutions in 1 country.

Jasmine C HuynhDivision of Hematology and Oncology, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
May ChoDivision of Hematology and Oncology, Irvine Comprehensive Cancer Center, University of California, Orange, CA, 92868, USA.
Arta MonjazebDepartment of Radiation Oncology, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
Ebaa Al-ObeidiDivision of Hematology and Oncology, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
Amisha SinghDepartment of Internal Medicine, University of California, Davis Medical Center, Sacramento, CA, 95817, USA.
Kit TamDivision of Hematology and Oncology, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
Frances LaraOffice of Clinical Research, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
Anthony MartinezOffice of Clinical Research, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
Leslie GarciaOffice of Clinical Research, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA.
Edward J KimDivision of Hematology and Oncology, Davis Comprehensive Cancer Center, University of California, Sacramento, CA, 95817, USA. jhkim@ucdavis.edu.ORCID 0000-0002-8660-7465
University of California, Davis · USUniversity of California Davis Medical Center · USUniversity of California, Irvine Medical Center · US

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI KC KENT LLOYD · 2002 to 2026
$84.9M
NCI NIH HHS P30 CA093373
6 · The paper itself

Abstract

backgroundIndoleamine-2,3-dioxygenase (IDO) helps orchestrate immune suppression and checkpoint inhibitor resistance in hepatocellular carcinoma (HCC). BMS-986,205 is a novel oral drug that potently and selectively inhibits IDO. This Phase I/II study evaluated the safety and tolerability of BMS-986,205 in combination with nivolumab as first-line therapy in advanced HCC.

methodsAdults with untreated, unresectable/metastatic HCC received BMS-986,205 at two dose levels (50-100 mg orally daily) in combination with fixed dose nivolumab (240mg/m

resultsEight patients received a total of 91 treatment cycles in the dose escalation phase. All patients were Child Pugh A and 6 patients had underlying viral hepatitis. In the 6 evaluable patients, no dose-limiting toxicities (DLTs) were observed. The most common treatment-related adverse events (TRAEs) were aspartate transaminase (AST) and alanine transaminase (ALT) elevation (3 patients) and diarrhea, maculopapular rash and increased alkaline phosphatase (2 patients each). Grade 3 events were diarrhea and AST elevation (1 patient), and hyperglycemia and pancreatitis requiring treatment discontinuation (1 patient). No grade 4-5 events occurred. Partial response was observed in 1 patient (12.5%) and stable disease in 3 patients (37.5%), yielding a disease control rate of 50%. Median PFS was 8.5 weeks; median OS was not reached.

conclusionCombination BMS-986,205 and nivolumab showed a manageable safety profile with durable benefit as first-line therapy in a meaningful subset of advanced HCC patients.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsAdultAlanine TransaminaseAspartate AminotransferasesDiarrheaHumansNivolumabAlanine TransaminaseAspartate AminotransferasesNivolumabHepatocellular carcinomaImmunotherapyIndoleamine 2,3-dioxygenaseNivolumab

Identifiers

PMID38038862
PMCPMC10891185
OpenAlexW4389225862

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.