Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Color… (NCT02982694) | Clinical Trial Compass
TerminatedPhase 2
Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer
Stopped: The results of the interim analysis showed that the efficacy in the MSS subgroup (MSI like) is inferior to the expected, and this situation is very unlikely to be reversed if the trial is fully completed.
The primary objective of this study is to determine the anti-tumor activity, as measured by overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with chemotherapy resistant CRC and positivity for MSI-like molecular signature. This is an international, open-label single arm (non-randomized), one-stage phase II trial.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent must be given according to ICH/GCP and national/local regulations.
* Histological or cytological proof of metastatic CRC.
* Disease progression or relapse after at least one line of treatment for advanced CRC with a fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab are allowed).
* Written documentation of positivity for MSI-like gene signature as determined by Agendia test.
* Unresectable disease, with at least one measurable lesion according to RECIST 1.1.
* Age ≥ 18 years.
* WHO performance status of 0-1.
* Ability and capacity to comply with study and follow-up procedures.
* Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 calendar days prior to the first study treatment:
* ANC \> 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
* WBC counts \> 2500/μL
* Platelet count \> 100,000/ μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
* Hemoglobin \> 9.0 g/dL
* AST, ALT, and alkaline phosphatase \< 2.5 x ULN, with the following exceptions:
* Patients with documented liver metastases: AST and ALT \< 5 x ULN
* Patients with documented liver or bone metastases: alkaline phosphatase \< 5 x ULN Bilirubin \<1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level \< 3 x ULN…