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Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase II Open-label Study With the Anti-PD-L1 Atezolizumab Monoclonal Antibody in Combination With Bevacizumab in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and MSI-like Molecular Signature

NCT02982694•Vall d'Hebron Institute of Oncology

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+13 more criteria

Exclusion Criteria

•Any treatment with investigational drugs (bevacizumab is not considered investigational drug in CRC) within 28 days prior to Cycle 1, Day 1.
•Previous cytotoxic agent within 14 days of planed treatment initiation.
•Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI)
•* Note: Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
•* Evaluable or measurable disease outside the CNS
•* No metastases to midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
•* No history of intracranial or spinal cord haemorrhage
•* No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose are allowed.
•* No evidence of significant vasogenic edema.
•* No stereotactic radiation, whole-brain radiation or neurosurgical resection within 4 weeks prior to Cycle 1, Day 1.
+30 more criteria

Locations (7)

KU Leuven

Leuven, Belgium

Ospedale Niguarda CA Granda

Milan, Italy

Second University of Naples

Naples, Italy

The Netherlands Cancer Institute

Amsterdam, Netherlands

Institut Català d'Oncologia

Barcelona, Spain

Vall d'Hebron Institute of Oncology

Barcelona, Spain

Fundación Investigación Clínico de Valencia

Valencia, Spain

Key Dates

Start Date

November 24, 2017

Primary Completion Date

November 27, 2020

Completion Date

November 27, 2020

Last Updated

October 1, 2025

Enrollment

ACTUAL participants

Conditions

MSIColoRectal CancerChemotherapyResistance, APC

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors