Evidence map›Paper›PMID 40166913›Full record

Trial reportCancer medicine2025

Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma (ACC) of all Anatomic Sites of Origin and Other Malignant Salivary Gland Tumors.

Young Kwang Chae, Richard Duan, Liam Il-Young Chung, Youjin Oh, Borislav Alexiev, Sangwon Shin, Sukjun Kim, Irene Helenowski, Maria Matsangou, Victoria Villaflor and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03146650 (Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma of All Anatomic Sites of Origin and Non-adenoid Cystic Carcinoma Malignant Tumors of the Salivary Gland), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–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.

NCT03146650 phase2unknown statusnot on this map

Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma of All Anatomic Sites of Origin and Non-adenoid Cystic Carcinoma Malignant Tumors of the Salivary Gland

TypeinterventionalSponsorNorthwestern UniversityRan2017 to 2025Enrolled25ConditionsMajor Salivary Gland Carcinoma, Minor Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage IV Major Salivary Gland CarcinomaArmsIpilimumab, Laboratory Biomarker Analysis, Nivolumab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
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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

11 authors.

Young Kwang ChaeDepartment of Hematology and Oncology, Northwestern University, Chicago, Illinois, USA.
Richard DuanFeinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0003-4098-262X
Liam Il-Young ChungFeinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0001-6541-793X
Youjin OhFeinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-9012-5258
Borislav AlexievDepartment of Surgical Pathology, Northwestern University, Chicago, Illinois, USA.
Sangwon ShinLunit, Seoul, Republic of Korea.
Sukjun KimLunit, Seoul, Republic of Korea.
Irene HelenowskiFeinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Maria MatsangouAstellas Pharmaceuticals, Northbrook, Illinois, USA.
Victoria VillaflorDepartment of Medical Oncology, City of Hope, Los Angeles, California, USA.
Devalingam MahalingamDepartment of Hematology and Oncology, Northwestern University, Chicago, Illinois, USA.

Funding

Bristol Myers Squibb Foundation
6 · The paper itself

Abstract

objectiveDual checkpoint inhibitor therapy with nivolumab and ipilimumab has been FDA approved for a number of cancer sites. However, its role in the treatment of ACC and non-ACC salivary gland carcinomas (non-ACC SGC) is not well established. METHODS AND ANALYSIS: We performed Simon's two-stage prospective single-institution Phase II clinical trial of nivolumab with ipilimumab. Two cohorts were analyzed: patients with metastatic/recurrent ACC and patients with non-ACC SGC. The primary endpoint was median progression-free survival (PFS); secondary endpoints were overall response rate (ORR), overall survival (OS), and toxicity.

resultsPatient enrollment was prematurely terminated due to funding constraints. In total, 19 patients with ACC and 5 patients with non-ACC SGC were enrolled. The patients with ACC had a median OS of 30.0 months (95% CI 15.3-NR months), a median PFS of 8.3 months (95% CI 5.5-30.0 months), and a disease control rate (DCR) of 53% (10/19). The ORR in the ACC group was 5% (CR 0%, n = 0; confirmed PR 5%, n = 1), with one patient having continued stable disease at the time of trial conclusion. The patients with non-ACC SGC had a median OS of 10.4 months (95% CI 6.21-NR months), a median PFS of 6.21 months (95% CI 2.83-NR months), and a DCR of 40% (2/5). The ORR in this cohort was 0%.

conclusionIn patients with recurrent or metastatic ACC and non-ACC SGC, the combination of nivolumab with ipilimumab resulted in moderate disease control. Further studies are warranted to validate our findings. TRIAL NUMBER: NCT03146650.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Adenoid CysticIpilimumabNeoplasm Recurrence, LocalNivolumabSalivary Gland NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesIpilimumabNivolumab

Identifiers

PMID40166913
PMCPMC11959299

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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.