Avelumab Plus Autologous Dendritic Cell Vaccine in Pre-treated Metastatic Colorectal Cancer Patients (NCT03152565) | Clinical Trial Compass
CompletedPhase 1/2
Avelumab Plus Autologous Dendritic Cell Vaccine in Pre-treated Metastatic Colorectal Cancer Patients
Spain28 participantsStarted 2018-03-12
Plain-language summary
Single arm Phase I/II multicentric open labeled, with translational sub-study, of avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients..
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent of approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
* Histological diagnosis of MSS colorectal adenocarcinoma.
* Metastatic disease treated with at least two chemotherapy line, with or without targeted therapies.
* Male or female subjects aged ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
* Lactate dehydrogenase (LDH) levels (\<1.5 ULN) (between 250-450 U/L). Maximum allowed 675 U/L.
* Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normality (ULN) and Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
* Negative serum pregnancy test at screening for women of childbearing potential.
* Highly effective contraception for both male and female subjects throughout the study and for at least 60 days after last avelumab treatment administration if the risk of conception exists.
* Adequate hematological function: a) Haemoglobin ≥ 9 g/dL (may have been transfused).
b) Platelet count ≥ 100 × 109/L. c) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
* Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (…
What they're measuring
1
Dose of Avelumab in combination with Autologous Dendritic Cells
Timeframe: 18 months
2
Progression Free Survival
Timeframe: 6 months
Trial details
NCT IDNCT03152565
SponsorGrupo Espanol Multidisciplinario del Cancer Digestivo