Evidence map›Paper›PMID 37382656›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

Results of an Open-label, Phase Ia/b Study of Pembrolizumab plus Olaratumab in Patients with Unresectable, Locally Advanced, or Metastatic Soft-Tissue Sarcoma.

Patrick Schöffski, Rastislav Bahleda, Andrew J Wagner, Melissa A Burgess, Niels Junker, Michael Chisamore, Patrick Peterson, Anna M Szpurka, Matteo Ceccarelli, William D Tap

Open access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.0field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 14 citations in OpenAlex.

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  10. Role of Immunotherapy in Sarcomas.International journal of molecular sciences · 2024
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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

10 authors at 8 institutions in 5 countries.

Patrick SchöffskiUniversity Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.ORCID 0000-0001-5980-030X
Rastislav BahledaGustave Roussy, Villejuif, France.ORCID 0009-0001-8245-0544
Andrew J WagnerDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-4384-9448
Melissa A BurgessHillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.ORCID 0000-0002-5753-1422
Niels JunkerHerlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.ORCID 0000-0001-8348-9363
Michael ChisamoreMerck & Co., Inc., Rahway, New Jersey.ORCID 0009-0006-8629-8232
Patrick PetersonEli Lilly & Company, Indianapolis, Indiana.ORCID 0009-0004-9692-8897
Anna M SzpurkaEli Lilly & Company, Indianapolis, Indiana.ORCID 0000-0002-1348-955X
Matteo CeccarelliEli Lilly & Company, Indianapolis, Indiana.ORCID 0009-0000-6780-3957
William D TapMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-7779-2796
Eli Lilly (United States) · USDana-Farber Cancer Institute · USGentofte Hospital · DKInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USUPMC Hillman Cancer Center · USVIB-KU Leuven Center for Cancer Biology · BE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Targeting Oncogenic Pathways in Genetically Complex SarcomasP50CA217694 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Marc Ladanyi · 2018 to 2026
$21.5M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA217694
6 · The paper itself

Abstract

purposeThe study evaluated safety and efficacy of olaratumab + pembrolizumab in patients with unresectable locally advanced/metastatic soft-tissue sarcoma (STS) with disease progression on standard treatment. PATIENTS AND

methodsThis was open-label, multicenter, nonrandomized, phase Ia/Ib dose-escalation study followed by cohort expansion (olaratumab + pembrolizumab intravenous infusion). Primary objectives were safety and tolerability.

resultsThe majority of patients enrolled (n = 41) were female [phase Ia: 9 of 13, phase Ib/dose-expansion cohort (DEC), 17 of 28], aged < 65 years. In phases Ia and Ib, 13 and 26 patients received prior systemic therapy, respectively. Patients received olaratumab 15 mg/kg (phase Ia; cohort 1) or 20 mg/kg (phase Ia; cohort 2 and phase Ib) and pembrolizumab 200 mg (phase Ia/Ib). The median (Q1-Q3) duration of therapy (olaratumab) was 6.0 (3.0-11.9; cohort 1), 14.4 (12.4-20.9; cohort 2), and 14.0 (6.0-21.8) weeks (DEC). No dose-limiting toxicities and few grade ≥ 3 treatment-emergent adverse events [TEAE; 15 mg/kg: 2 (increased lipase); 20 mg/kg: 1 (increased lipase), 1 (colitis), 2 (diarrhea), 3 (anemia)] were reported. Two TEAEs (increased lipase) were related to study discontinuations. Twenty-one patients reported mild (grade ≤ 2) TEAEs [phase Ia, disease control rate (DCR):14.3% (1/7, cohort 1); 66.7% (4/6, cohort 2); no responses were reported; phase Ib, DCR: 53.6% (15/28); objective response rate: 21.4% (6/28; RECIST and irRECIST criteria)]. No response was observed in patients with programmed death ligand-1-positive tumors.

conclusionsAntitumor activity was observed in some patients in DEC, and combination was well tolerated with manageable safety profile. Further studies are warranted to evaluate the efficacy and mechanistic impact of platelet-derived growth factor receptor inhibitors with immune checkpoint modulator coadministration.

Indexed as

Neoplasms, Second PrimarySarcomaSoft Tissue NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedolaratumabpembrolizumab

Identifiers

PMID37382656
PMCPMC10472093
OpenAlexW4382502356

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.