Evidence map›Paper›PMID 35662283›Full record

Trial reportNature medicine2022

Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial.

Lacey J Padrón, Deena M Maurer, Mark H O'Hara, Eileen M O'Reilly, Robert A Wolff, Zev A Wainberg, Andrew H Ko, George Fisher, Osama Rahma, Jaclyn P Lyman and 27 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 256 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
256citing papers in PubMed, 7 pooled it
31.6field-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.

NCT03214250 phase1 / phase2completednot on this map

Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

TypeinterventionalSponsorParker Institute for Cancer ImmunotherapyRan2017 to 2022Enrolled129ConditionsMetastatic Pancreatic AdenocarcinomaArmsAPX005M, Nivolumab, Nab-Paclitaxel, Gemcitabine
NCT06050317 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial

TypeinterventionalSponsorShandong Cancer Hospital and InstituteRan2023 to 2026Enrolled25ConditionsPancreas CancerArmsSintilimab Plus mFFN or NALIRIFOX and Radiation
3 · Its place in the literature

Who cites it

256 citing papers in PubMed, 7 syntheses or guidelines pooled it, 325 citations in OpenAlex.

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  15. CD27 Agonist Antibodies Mediate Clinical Responses through Intratumoral Stimulation in B-cell Malignancies: Multicenter RiVa Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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196 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

37 authors at 13 institutions in 2 countries.

Lacey J Padrón *Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA. lpadron@parkerici.org.ORCID http://orcid.org/0000-0003-0064-5565
Deena M Maurer *Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Mark H O'Hara *Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0002-8076-9199
Robert A WolffThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zev A WainbergUniversity of California, Los Angeles, Los Angeles, CA, USA.
Andrew H KoUniversity of California, San Francisco, San Francisco, CA, USA.
George FisherStanford University, Stanford, CA, USA.
Osama RahmaDana-Farber Cancer Institute, Boston, MA, USA.
Jaclyn P LymanParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Christopher R CabanskiParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Jia Xin YuParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Shannon M PfeifferParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Marko SpasicParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Jingying XuParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Pier Federico GherardiniParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Joyson KarakunnelParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Rosemarie MickAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
Cécile AlanioAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
Katelyn T ByrneAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
Travis J HollmannMemorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0003-1599-0433
Jonni S MooreAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0002-2975-336X
Derek D JonesAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
Marco TognettiBiognosys AG, Schlieren, Switzerland.ORCID http://orcid.org/0000-0002-2379-1525
Richard O ChenPersonalis, Inc., Menlo Park, CA, USA.ORCID http://orcid.org/0000-0002-2842-4476
Xiaodong YangApexigen, Inc., San Carlos, CA, USA.
Lisa SalvadorBristol Myers Squibb, New York, NY, USA.
E John WherryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0003-0477-1956
Ute DuganParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Jill O'Donnell-TormeyCancer Research Institute, New York, NY, USA.
Lisa H ButterfieldParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-3439-9844
Vanessa M Hubbard-LuceyCancer Research Institute, New York, NY, USA.
Ramy IbrahimParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Justin FairchildParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Samantha BucktroutParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Theresa M LaValleeParker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Robert H VonderheideAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA. rhv@upenn.edu.ORCID http://orcid.org/0000-0002-7252-954X
Parker Institute for Cancer Immunotherapy · USUniversity of Pennsylvania · USCancer Research Institute · USMemorial Sloan Kettering Cancer Center · USApexigen (United States) · USBiognosys (Switzerland) · CHBristol-Myers Squibb (United States) · USDana-Farber Cancer Institute · USPersonalis (United States) · USStanford University · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, Los Angeles · USUniversity of California, San Francisco · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Chemotherapy combined with immunotherapy has improved the treatment of certain solid tumors, but effective regimens remain elusive for pancreatic ductal adenocarcinoma (PDAC). We conducted a randomized phase 2 trial evaluating the efficacy of nivolumab (nivo; anti-PD-1) and/or sotigalimab (sotiga; CD40 agonistic antibody) with gemcitabine/nab-paclitaxel (chemotherapy) in patients with first-line metastatic PDAC ( NCT03214250 ). In 105 patients analyzed for efficacy, the primary endpoint of 1-year overall survival (OS) was met for nivo/chemo (57.7%, P = 0.006 compared to historical 1-year OS of 35%, n = 34) but was not met for sotiga/chemo (48.1%, P = 0.062, n = 36) or sotiga/nivo/chemo (41.3%, P = 0.223, n = 35). Secondary endpoints were progression-free survival, objective response rate, disease control rate, duration of response and safety. Treatment-related adverse event rates were similar across arms. Multi-omic circulating and tumor biomarker analyses identified distinct immune signatures associated with survival for nivo/chemo and sotiga/chemo. Survival after nivo/chemo correlated with a less suppressive tumor microenvironment and higher numbers of activated, antigen-experienced circulating T cells at baseline. Survival after sotiga/chemo correlated with greater intratumoral CD4 T cell infiltration and circulating differentiated CD4 T cells and antigen-presenting cells. A patient subset benefitting from sotiga/nivo/chemo was not identified. Collectively, these analyses suggest potential treatment-specific correlates of efficacy and may enable biomarker-selected patient populations in subsequent PDAC chemoimmunotherapy trials.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalPancreatic NeoplasmsAlbuminsAntibodies, MonoclonalAntineoplastic AgentsHumansNivolumabTumor MicroenvironmentAlbuminsAntibodies, MonoclonalAntineoplastic AgentsNivolumab

Identifiers

PMID35662283
PMCPMC9205784
OpenAlexW4282037063

What OpenQuestion holds

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LicenceCC BY
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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.