Evidence map›Paper›PMID 29119276›Full record

Trial reportInvestigational new drugs2018

Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma.

Glen J Weiss, Lisa Blaydorn, Julia Beck, Kirsten Bornemann-Kolatzki, Howard Urnovitz, Ekkhard Schütz, Vivek Khemka

Erratum issued 3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 154 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
154citing papers in PubMed, 5 pooled it
5.3field-weighted citation impact, top 3% 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.

NCT02331251 phase1 / phase2terminatednot on this map

A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)

TypeinterventionalSponsorWestern Regional Medical CenterRan2014 to 2018Enrolled81ConditionsAdvanced Cancer, Breast Cancer, Sarcoma, Pancreatic CancerArmsPembrolizumab, Gemcitabine, Docetaxel, Nab-paclitaxel, Vinorelbine
NCT04377048 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Nivolumab as add-on to Gemcitabine/S-1 in Metastatic Pancreatic Cancer: a Phase II Trial

TypeinterventionalSponsorNational Taiwan University HospitalRan2020 to 2022Enrolled38ConditionsStage IV Pancreatic CancerArmsNivolumab, Gemcitabine, Tegafur-Gimeracil-Oteracil
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

154 citing papers in PubMed, 5 syntheses or guidelines pooled it, 213 citations in OpenAlex.

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94 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Glen J WeissWestern Regional Medical Center, Cancer Treatment Centers of America, Goodyear, AZ, USA. drglenweiss@outlook.com.
Lisa BlaydornWestern Regional Medical Center, Cancer Treatment Centers of America, Goodyear, AZ, USA.
Julia BeckChronix Biomedical, Göttingen, Germany.
Kirsten Bornemann-KolatzkiChronix Biomedical, Göttingen, Germany.
Howard UrnovitzChronix Biomedical, Göttingen, Germany.
Ekkhard SchützChronix Biomedical, Göttingen, Germany.
Vivek KhemkaWestern Regional Medical Center, Cancer Treatment Centers of America, Goodyear, AZ, USA.
Goodyear (United States) · USWestern Regional Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background A single center phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab (GNP) to evaluate the safety and efficacy in metastatic pancreatic adenocarcinoma (PDAC) was conducted (NCT02331251). Methods PDAC patients (pts) with measurable disease, biopsy proven metastasis, adequate laboratory tests, and KPS ≥ 70% received GNP until progression or toxicity. Safety monitoring, RECIST 1.1, and irRECIST assessments were conducted. Response imaging was performed prior to cycle 4, then every 3 months. Changes in tumor cell-free DNA copy number instability (CNI) was retrospectively evaluated. Results 17 pts. with a median age of 56 were treated. 11 were women and all had a KPS of at least 80%. Grade 3 events occurred in 53% of patients. The phase II portion was completed for chemotherapy naïve PDAC pts. Of the 11 evaluable chemotherapy naïve PDAC, the disease control rate (partial response [PR] + stable disease[SD]) was 100%. There were 3 with PR on treatment for 8+, ~11, and 15 months; respectively. The primary endpoint of >15% complete response was not met. The median progression-free survival (PFS) and overall survival (OS) was 9.1 and 15.0 months for chemotherapy naïve treated patients. Of 9 patients evaluable for CNI change, a greater reduction in CNI correlated with longer PFS and improved OS. Conclusions GNP can be safely given to chemotherapy naïve PDAC patients. Efficacy appears to be slightly improved over previously reported results for standard weekly × 3 every 28 day gemcitabine and nab-paclitaxel dosing. CNI change may be prognostic for OS.

Indexed as

AdenocarcinomaAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedPaclitaxelPancreatic NeoplasmsTreatment Outcome130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDeoxycytidineGemcitabinePaclitaxelpembrolizumabChemotherapyClinical trialCopy number instabilityImmunotherapyMetastaticPancreatic ductal adenocarcinomaPhase Ib/II

Identifiers

PMID29119276
OpenAlexW2767403472

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.