Evidence map›Paper›PMID 31725351›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164.

Dung T Le, Tae Won Kim, Eric Van Cutsem, Ravit Geva, Dirk Jäger, Hiroki Hara, Matthew Burge, Bert O'Neil, Petr Kavan, Takayuki Yoshino and 12 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 570 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
570citing papers in PubMed, 6 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.

NCT02460198 phase2completednot on this map

A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2021Enrolled124ConditionsColorectal CarcinomaArmsPembrolizumab
NCT07142226 recruitingnot on this mapstarted 2025, after this paper: background citation

Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - A Multicenter, Prospective, Observational Epidemiology Study

TypeobservationalSponsorCHA UniversityRan2025 to 2027Enrolled200ConditionsBiliary Tract CancerArmsCirculating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS))
NCT07151118 recruitingnot on this mapstarted 2025, after this paper: background citation

Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - Prospective, Observational, Epidemiology Study

TypeobservationalSponsorCHA UniversityRan2025 to 2027Enrolled100ConditionsBiliary Tract CancerArmsBlood Sampling for ctDNA Analysis
3 · Its place in the literature

Who cites it

570 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Dung T LeSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Tae Won KimAsan Medical Center, Seoul, Republic of Korea.
Eric Van CutsemUniversity Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium.
Ravit GevaTel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Dirk JägerNationales Centrum Tumorerkrankungen, Heidelberg, Germany.
Hiroki HaraSaitama Cancer Center, Saitama, Japan.
Matthew BurgeRoyal Brisbane and Women's Hospital, Herston, QLD, Australia.
Bert O'NeilIndiana University Health University Hospital, Indianapolis, IN.
Petr KavanMcGill University Health Centre, Montréal, Québec, Canada.
Takayuki YoshinoNational Cancer Center Hospital East, Chiba, Japan.
Rosine GuimbaudCentre Hospitalier Universitaire de Toulouse, Toulouse, France.
Hiroya TaniguchiAichi Cancer Center Hospital, Aichi, Japan.
Elena ElezVall d'Hebron Institute of Oncology, Barcelona, Spain.
Salah-Eddin Al-BatranKrankenhaus Nordwest, Frankfurt, Germany.
Patrick M BolandRoswell Park Comprehensive Cancer Center, Buffalo, NY.
Todd CrocenziProvidence Cancer Center, Portland, OR.
Chloe E AtreyaUniversity of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.
Yi CuiMSD China, Beijing, People's Republic of China.
Tong DaiMerck & Co Inc, Kenilworth, NJ.
Patricia MarinelloMerck & Co Inc, Kenilworth, NJ.
Luis A DiazMemorial Sloan Kettering Cancer Center, New York, NY.
Thierry AndréSorbonne Université, Paris, France.

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

purposeKEYNOTE-164 (NCT02460198) evaluated the antitumor activity of pembrolizumab in previously treated, metastatic, microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC).

methodsThis phase II open-label study involved 128 centers worldwide. Eligible patients were age ≥ 18 years and had metastatic MSI-H/dMMR CRC treated with ≥ 2 prior lines of standard therapy, including fluoropyrimidine, oxaliplatin, and irinotecan with or without anti-vascular endothelial growth factor/epidermal growth factor receptor monoclonal antibody (cohort A) or ≥ 1 prior line of therapy (cohort B). MSI-H/dMMR status was assessed locally. Patients received pembrolizumab 200 mg every 3 weeks for up to 2 years until progression, unacceptable toxicity, or withdrawal. The primary end point was objective response rate by RECIST version 1.1 by independent central review. Secondary end points were duration of response, progression-free survival (PFS), overall survival, safety, and tolerability.

resultsA total of 124 patients with MSI-H/dMMR CRC (61 in cohort A, 63 in cohort B) enrolled. At data cutoff, median follow-up was 31.3 months (range, 0.2-35.6 months) for cohort A and 24.2 months (range, 0.1-27.1 months) for cohort B. Objective response rate was 33% (95% CI, 21% to 46%) and 33% (95% CI, 22% to 46%), respectively, with median duration of response not reached in either cohort. Median PFS was 2.3 months (95% CI, 2.1 to 8.1 months) and 4.1 months (95% CI, 2.1 to 18.9 months). Median overall survival was 31.4 months (95% CI, 21.4 months to not reached) and not reached (95% CI, 19.2 months to not reached). Treatment-related grade 3-4 adverse events occurred in 10 patients (16%) in cohort A and 8 (13%) in cohort B, with the most common occurring in ≥ 2 patients being pancreatitis, fatigue, increased alanine aminotransferase, and increased lipase (2 patients each; 3%) in cohort A.

conclusionPembrolizumab is effective with a manageable safety profile in patients with MSI-H/dMMR CRC.

Indexed as

DNA Mismatch RepairMicrosatellite InstabilityAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCohort StudiesColorectal NeoplasmsDrug Administration ScheduleFemaleHumansInfusions, IntravenousMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumab

Identifiers

PMID31725351
PMCPMC7031958

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.