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NCT03150706

Avelumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer

Status unknown Phase 2 Last updated 3 April 2020
What this trial tests

Phase 2 trial testing Avelumab in Metastatic Colorectal Cancer in 33 participants. Status unknown.

Timeline
22 May 2017
Primary endpoint
31 July 2021
31 December 2021

Quick facts

Lead sponsorAsan Medical Center
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date22 May 2017
Primary completion31 July 2021
Estimated completion31 December 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Asan Medical Center

Who can join

20 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The POLE mutations represent high somatic mutation loads in patients with colorectal cancer, especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations might be susceptible to immune checkpoint blockade. Based on these reasons, Investigator planned a phase II study of avelumab monotherapy in patients with previously treated, metastatic, MMR deficient (MSI-H) or POLE mutated colorectal cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunotherapy in colorectal cancer: rationale, challenges and potential.
    Ganesh K, Stadler ZK, Cercek A, Mendelsohn RB, et al · · 2019 · cited 1407× · PMID 30886395 · DOI 10.1038/s41575-019-0126-x
  2. Comprehensive review of targeted therapy for colorectal cancer.
    Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
  3. Mismatch repair deficiency/microsatellite instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy efficacy.
    Zhao P, Li L, Jiang X, Li Q. · · 2019 · cited 503× · PMID 31151482 · DOI 10.1186/s13045-019-0738-1
  4. Relationships Between Immune Landscapes, Genetic Subtypes and Responses to Immunotherapy in Colorectal Cancer.
    Picard E, Verschoor CP, Ma GW, Pawelec G. · · 2020 · cited 401× · PMID 32210966 · DOI 10.3389/fimmu.2020.00369
  5. Immunotherapy in colorectal cancer: current achievements and future perspective.
    Fan A, Wang B, Wang X, Nie Y, et al · · 2021 · cited 321× · PMID 34671202 · DOI 10.7150/ijbs.64077
  6. Microsatellite instability in colorectal cancer: overview of its clinical significance and novel perspectives.
    Battaglin F, Naseem M, Lenz HJ, Salem ME. · · 2018 · cited 163× · PMID 30543589
  7. Immunotherapy efficacy on mismatch repair-deficient colorectal cancer: From bench to bedside.
    Lizardo DY, Kuang C, Hao S, Yu J, et al · · 2020 · cited 160× · PMID 33035640 · DOI 10.1016/j.bbcan.2020.188447
  8. Research Status and Outlook of PD-1/PD-L1 Inhibitors for Cancer Therapy.
    Ai L, Chen J, Yan H, He Q, et al · · 2020 · cited 149× · PMID 32982171 · DOI 10.2147/dddt.s267433

Verify or expand the search:

Other trials of Avelumab

Trials testing the same drug.

Other recruiting trials for Metastatic Colorectal Cancer

Currently open trials in the same condition.

Other Asan Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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