Evidence map›Paper›PMID 39106081›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024

A Phase Ib/II Randomized Clinical Trial of Oleclumab with or without Durvalumab plus Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Andrew L Coveler, Matthew J Reilley, Mark Zalupski, Teresa Macarulla, Christos Fountzilas, Mariano Ponz-Sarvisé, Adnan Nagrial, Nataliya V Uboha, Sophia Frentzas, Michael Overman and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03611556 (A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 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.

NCT03611556 phase1 / phase2completednot on this map

A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

TypeinterventionalSponsorMedImmune LLCRan2018 to 2022Enrolled213ConditionsCarcinoma, Metastatic Pancreatic AdenocarcinomaArmsOleclumab, Durvalumab, Gemcitabine, Nab-paclitaxel, Oxaliplatin
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  13. Dual blockade of adenosine AFrontiers in immunology · 2026
    Article
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  17. Adenosine Kinase: An Epigenetic Modulator and Drug Target.Journal of inherited metabolic disease · 2025
    Review
  18. Advancing Immunotherapy in Pancreatic Cancer.International journal of molecular sciences · 2024
    Review
  19. Review
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

23 authors.

Andrew L CovelerFred Hutchinson Cancer Center, Seattle, Washington.ORCID 0000-0003-1710-5637
Matthew J ReilleyUniversity of Virginia Comprehensive Cancer Center, Charlottesville, Virginia.ORCID 0000-0002-4725-0459
Mark ZalupskiUniversity of Michigan Health System, Ann Arbor, Michigan.ORCID 0000-0002-2114-9352
Teresa MacarullaVall d'Hebrón Institute of Oncology (VHIO), Vall d'Hebrón University Hospital, Barcelona, Spain.ORCID 0000-0002-5856-4082
Christos FountzilasRoswell Park Comprehensive Cancer Center, Buffalo, New York.ORCID 0000-0003-3837-5644
Mariano Ponz-SarviséCancer Center Clinica Universidad de Navarra, Pamplona, Spain.ORCID 0000-0002-3240-729X
Adnan NagrialBlacktown Hospital, Sydney, Australia.ORCID 0000-0003-0275-2479
Nataliya V UbohaUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin.ORCID 0000-0003-3449-1680
Sophia FrentzasMonash Medical Centre, Clayton, Australia.ORCID 0000-0002-6917-9737
Michael OvermanThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-5377-135X
Anne NoonanThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.ORCID 0000-0001-8083-8492
Wells A MessersmithUniversity of Colorado Cancer Center, Aurora, Colorado.ORCID 0000-0003-2349-0885
Nick PavlakisNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.ORCID 0000-0002-1738-0316
Niharika B MettuDuke University Medical Center, Durham, North Carolina.ORCID 0000-0002-7821-3298
Ina BishaAstraZeneca, Munich, Germany.ORCID 0009-0009-8609-6376
Ying WangAstraZeneca, Waltham, Massachusetts.ORCID 0009-0008-5862-2239
Paul SmithOn behalf of AstraZeneca, Cambridge, United Kingdom.ORCID 0009-0005-5418-2545
Elina MurtomakiAstraZeneca, Cambridge, United Kingdom.ORCID 0009-0009-1285-9238
Agata A BielskaAstraZeneca, Waltham, Massachusetts.ORCID 0000-0002-6502-0972
Veronique BragulatAstraZeneca, Cambridge, United Kingdom.ORCID 0009-0002-0738-1814
Zachary A CooperAstraZeneca, Gaithersburg, Maryland.ORCID 0000-0003-1059-0940
Rakesh KumarAstraZeneca, Gaithersburg, Maryland.ORCID 0000-0002-4627-3667
David R SpigelSarah Cannon Research Institute, Nashville, Tennessee.ORCID 0000-0003-3215-9465

Funding

AstraZeneca (AstraZeneca PLC)
6 · The paper itself

Abstract

purposePancreatic ductal adenocarcinoma upregulates CD73, potentially contributing to immune surveillance evasion. Combining oleclumab (CD73 inhibitor) and durvalumab with chemotherapy may identify an effective treatment option. PATIENTS AND

methodsWe describe a multicenter phase Ib/II randomized clinical trial in patients with metastatic pancreatic ductal adenocarcinoma, untreated (cohort A) or previously received gemcitabine-based chemotherapy (cohort B; NCT03611556). During escalation, patients received oleclumab 1,500 or 3,000 mg, durvalumab 1,500 mg, and gemcitabine plus nab-paclitaxel (GnP; cohort A; n = 14) or modified FOLFOX (cohort B; n = 11). During expansion, cohort A patients (n = 170) were randomized to GnP (arm A1), oleclumab [recommended phase II dose (RP2D)] with GnP (arm A2), or oleclumab (RP2D) with durvalumab plus GnP (arm A3). Primary objectives were safety (escalation) and objective response rate (expansion). Secondary objectives included progression-free survival (PFS) and overall survival (OS).

resultsDuring escalation, 1/11 patients from cohort B (oleclumab 3,000 mg) experienced two dose-limiting toxicities. Oleclumab's RP2D was 3,000 mg. During expansion, grade ≥3 treatment-related adverse events occurred in 67.7% (42/62) of patients in A1, 73.7% (28/38) in A2, and 77.1% (54/70) in A3. The objective response rate was 29.0%, 21.1%, and 32.9% in A1, A2, and A3, respectively (A1 vs. A3; P = 0.650). PFS [HR = 0.72; 95% confidence interval (CI), 0.47, 1.11] and OS (HR = 0.75; 95% CI, 0.50-1.13) were similar for A3 versus A1. Patients with high CD73 expression had improved PFS and OS in A3 versus A1, although this should be interpreted with caution.

conclusionsAlthough the safety profile was acceptable, this study did not meet its primary efficacy endpoint.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedNeoplasm MetastasisPaclitaxelPancreatic NeoplasmsProgression-Free SurvivalAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabPaclitaxel

Identifiers

PMID39106081
PMCPMC11474165

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.