Avelumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer (NCT03150706) | Clinical Trial Compass
UnknownPhase 2
Avelumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer
South Korea33 participantsStarted 2017-05-22
Plain-language summary
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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum.
✓. Mismatch repair deficient or microsatellite instable (defined below), or POLE mutated tumors A. Mismatch repair deficient: loss of expression by immunohistochemical stains 4. ≥ 1 out of 4 markers (MLH1, MSH2, MSH6, PMS2) B. Microsatellite instable: loss of stability ≥2 out of 5 gene panels (BAT-25, BAT-26, D2S123, D5S345, D17S250)
✓. Progressed after at least first-line systemic chemotherapy for metastatic setting.
✓. ≥ 1 measurable lesion(s) by RECIST 1.1.
✓. Unresectable advanced or metastatic disease.
✓. Age over 20 years old.
✓. ECOG 0-1, but final decision by clinical.
✓. Adequate organ functions. A. Bone marrow function: Hemoglobin 9.0 g/dL, ANC 1,500/mm3, platelet 100,000/mm3 B. Hepatic functions: bilirubin ≤ 1.5 X ULN, AST/ALT ≤ 2.5 X ULN (≤ 5 X ULN in cases of liver metastasis) C. Renal functions: serum Cr ≤ 1.5 X ULN or calculated CCr (Cockroft) ≥ 30 ml/min
Exclusion criteria
✕. Any prior treatment with PD-1 or PD-L1 inhibitor.
✕. Receipt of the last dose of chemotherapy ≤ 28 days prior to the first dose of study drugs.
✕. Current or prior use of immunosuppressive medication within 28 days before the first dose of avelumab, with the exceptions for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
What they're measuring
1
Serum CEA, TSH, T3, free T4, EKG,CT (or MRI) scans of evaluable/measurable lesions by RECIST 1.1.
✕. Concurrent or previous history of another primary cancer within 3 years prior to randomisation except for curatively treated cervical cancer in situ, non-melanomatous skin cancer, superficial bladder cancer (pTis and pT1) and curatively treated thyroid cancer of any stage. Concurrent, histologically confirmed, unresected thyroid cancer without distant metastasis could be allowed with the agreement of the chief principal investigator.
✕. Uncontrolled CNS metastases; permitted if asymptomatic or neurologically stable.
✕. Prior radiation therapy would be permitted, but non-radiated evaluable lesions should be present at study entry.
✕. Radiation therapy during study treatment is not permitted, but if the local investigator decides that radiation therapy should be given during study treatments, he should be convinced that there is no evidence of disease progression with agreement of the chief principal investigator.
✕. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.