Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT02982694
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered 1200 mg in 250 ml 0.9% NaCl IV infusion bag, on day 1 of each cycle of 21 days.
  • Bevacizumab — DRUG
    Bevacizumab will be administered 7.5 ml/kg (diluted in 0.9% sodium chloride solution) on day 1 of each 21 days cycle.

Study Details

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.

Key Dates

Start date
Nov 24, 2017
Status verified
Sep 2025
Primary completion
Nov 27, 2020
Completion
Nov 27, 2020

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab and Bevacizumab
    Atezolizumab will be administered intravenously at 1200 mg on Day 1 every 3 weeks. The dose of bevacizumab in this study is 7.5 mg/kg administered by IV infusion every 3 weeks on Day 1 of each 21 days cycle. Atezolizumab will be administered first, followed by Bevacizumab, with a minimum of 5 minutes between dosing. The interval between cycle infusions must not be \< 10 days.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 36 months from first patient in ]

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