Evidence map›Paper›PMID 39846984›Full record

Trial reportThe oncologist2025

Pembrolizumab ± paricalcitol in metastatic pancreatic cancer postmaximal cytoreduction.

Vincent Chung, Angela Alistar, Carlos Becerra, Anup Kasi, Erkut Borazanci, Gayle S Jameson, Denise J Roe, Betsy C Wertheim, Derek Cridebring, Morgan Truitt and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03331562 (A SU2C Catalyst ® Randomized Phase II Trial of the PD1 Inhibitor Pembrolizumab With or Without a Vitamin D Receptor Agonist Paricalcitol in Patients With Stage IV Pancreatic Cancer Who Have Been Placed in Best Possible Response), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT03331562 phase2completednot on this map

A SU2C Catalyst ® Randomized Phase II Trial of the PD1 Inhibitor Pembrolizumab With or Without a Vitamin D Receptor Agonist Paricalcitol in Patients With Stage IV Pancreatic Cancer Who Have Been Placed in Best Possible Response

TypeinterventionalSponsorTranslational Genomics Research InstituteRan2017 to 2020Enrolled24ConditionsPancreatic Cancer, Pancreas Adenocarcinoma, Advanced Pancreatic Cancer, Metastatic Pancreatic CancerArmsPembrolizumab, paricalcitol, placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
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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

17 authors.

Vincent ChungCity of Hope National Medical Center, Duarte, CA, United States.ORCID 0000-0001-9475-808X
Angela AlistarAtlantic Medical Group-Oncology Morristown Medical Center, Morristown, NJ, United States.
Carlos BecerraHoag Memorial Hospital, Newport Beach, CA, United States.
Anup KasiUniversity of Kansas Medical Center, Westwood, KS, United States.
Erkut BorazanciHonorHealth Research Institute, Scottsdale, AZ, United States.ORCID 0000-0001-5136-5462
Gayle S JamesonHonorHealth Research Institute, Scottsdale, AZ, United States.
Denise J RoeUniversity of Arizona Cancer Center, Tucson, AZ, United States.
Betsy C WertheimUniversity of Arizona Cancer Center, Tucson, AZ, United States.
Derek CridebringTranslational Genomics Research Institute (TGen) A Part of City of Hope, Phoenix, AZ, United States.
Morgan TruittThe Salk Institute for Biological Studies, La Jolla, CA, United States.
Michael DownesThe Salk Institute for Biological Studies, La Jolla, CA, United States.
Michael T BarrettMayo Clinic, Scottsdale, AZ, United States.
Ron KornImaging Endpoints, Scottsdale, AZ.
Keehoon LeeTranslational Genomics Research Institute An Affiliate of City of Hope, Flagstaff, AZ, United States.
Haiyong HanTranslational Genomics Research Institute (TGen) A Part of City of Hope, Phoenix, AZ, United States.
Ronald EvansThe Salk Institute for Biological Studies, La Jolla, CA, United States.
Daniel D Von HoffHonorHealth Research Institute, Scottsdale, AZ, United States.

Funding

HRD-IA signatures in pancreatic ductal adenocarcinomaUH3CA238926 · NCI · MAYO CLINIC ARIZONA · PI BORAD, MITESH · 2022 to 2024
$966k
AACR SU2C-AACR-CT03-16Merck & Co., IncMerck Sharp & Dohme LLCNCI NIH HHS UH3 CA238926
6 · The paper itself

Abstract

lessons learnedIntravenous paricalcitol did not improve the efficacy of pembrolizumab, likely related to the short half-life.

backgroundImmunotherapy has limited benefit in the treatment of advanced pancreatic cancer with the tumor microenvironment playing a key role in immune resistance. In preclinical studies, vitamin D receptor (VDR) agonists have been shown to sensitize pancreatic tumors to PD-1 blockade.

methodsThis was a randomized, double-blinded, placebo-controlled, phase II trial to evaluate pembrolizumab with or without paricalcitol as maintenance therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants were ≥18 years; histologically or cytologically confirmed metastatic PDAC showing no disease progression after frontline systemic therapy, and achieving maximal cytoreduction (eg, with no further antitumor effect), Eastern Cooperative Oncology Group (ECOG) status of 0 or 1; adequate organ function. Study treatment included: pembrolizumab 200 mg IV every 3 weeks and either paricalcitol 25 mcg IV 3 times per week or placebo. The primary objective was to evaluate 6-month progression free survival (PFS). Secondary objectives include evaluating the toxicity of the combination and overall survival (OS).

resultsThere was no significant difference in 6-month PFS, median PFS, median OS, nor treatment-related AEs between the 2 arms. CONCLUSIONS AND RELEVANCE: Paricalcitol did not improve the efficacy of pembrolizumab likely related to its short half-life of only 5-7 hours. Microbiome analysis revealed significant difference between long-term (>12 weeks) and short-term (<12 weeks) survival groups across treatment arms. Modulation of the tumor microenvironment will likely require more sustained VDR activity.

trial registrationClinicaltrials.gov, ID: NCT03331562.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalCytoreduction Surgical ProceduresErgocalciferolsPancreatic NeoplasmsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedErgocalciferolsparicalcitolpembrolizumabadenocarcinomamaintenance therapypancreatic cancerParicalcitolpembrolizumab

Identifiers

PMID39846984
PMCPMC11756276

What OpenQuestion holds

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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.