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Trial Status

In Development

Cancer Type

Colorectal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Protocol Title

Avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III dMMR or POLE exonuclease domain mutant colon cancer: A phase III randomised study

PURPOSE OF THE STUDY

Colon cancer is the fourth most common cancer and approximately a one-quarter of patients are diagnosed with stage III colon cancer. Current treatment includes surgery followed by chemotherapy. Some people with colon cancer have changes to the structure of their genes, called a mutation.

About 12% people experience changes to their MMR genes and 1% have alteration in the gene called POLE. These gene abnormalities/mutations make them susceptible to response to drugs called immune checkpoint inhibitors. Studies have proven that these drugs improve survival in people having advanced colon cancer with the MMR mutation.

Primary Objective

To compare the rate of disease-free survival (DFS) at 3-years of adjuvant Avelumab after standard fluoropyrimidine-based chemotherapy versus standard fluoropyrimidine-based chemotherapy alone in patients with curatively resected, stage III dMMR or POLE exonuclease domain mutant colon cancer.

ELIGIBITILITY CRITERIA

Inclusion Criteria

  • Male or female subjects aged ≥18 years
  • Histologically proven, stage III adenocarcinoma of the colon
  • Fully surgically resected tumour with clear resection margins
  • Locally confirmed defective mismatch repair (dMMR) tumour
  • Absence of metastases as shown by post-operative CT scan
  • Negative serum or urine pregnancy test at screening for women of childbearing potential
  • Fertile men and women must agree to take highly effective contraceptive precautions during, and for 6 months after the last dose of chemotherapy or for 30 days after the last dose of Avelumab.

Exclusion Criteria

  • Rectal tumours.
  • Inability to start adjuvant chemotherapy within 12 weeks after surgery
  • Administration of neoadjuvant systemic chemotherapy or radiotherapy before surgical resection of colon cancer
  • Prior organ transplantation, including allogeneic stem cell transplantation
  • Significant acute or chronic infections including, among others:
    • known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    • positive test for HBV surface antigen or anti-HCV antibody and confirmatory HCV RNA test

CONTACT EMAIL

TBC

DETAILED INFORMATION AVAILABLE

TBC

FUNDING

MRFF Grant 2019

Trial Status

In Development

Cancer Type

Colorectal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Protocol Title

Avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III dMMR or POLE exonuclease domain mutant colon cancer: A phase III randomised study

Background

Colon cancer is the fourth most common cancer and approximately a one-quarter of patients are diagnosed with stage III colon cancer. Current treatment includes surgery followed by chemotherapy. Some people with colon cancer have changes to the structure of their genes, called a mutation. About 12% people experience changes to their MMR genes and 1% have alteration in the gene called POLE. These gene abnormalities/mutations make them susceptible to response to drugs called immune checkpoint inhibitors. Studies have proven that these drugs improve survival in people having advanced colon cancer with MMR mutation.

In this study we will randomise (1:1) 50 people to receive either 3 months of chemotherapy alone (with agents called CAPEOX or capecitabine) or chemotherapy followed by 6 months of immune checkpoint inhibitor called avelumab, to see whether avelumab decreases the disease from coming back at 3 years. Assessments will include disease free survival and overall survival, quality of life, toxicity and health resource use. After completing treatment, people are planned to be followed up once every 3 months in the first year, once every 6 months in the second and third year and annually thereafter till the seventh year.