Loading clinical trials...

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

ElevatION: CRC-101: A Phase Ib Study of PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

NCT03176264•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis). The study was terminated early due to company decision.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with metastatic MSS colorectal adenocarcinoma.Note: MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
•2. Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis (mandatory)
•3. Patients must provide a newly obtained tumor tissue sample from a metastatic site (mandatory)
•5. Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.
•9\. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria

•1. Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
•2. Patients with metastatic disease amenable to be resected with potentially curative surgery
•3. Patients who have received any systemic treatment for metastatic disease.
•4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
•5. Patients who had received radiation within 14 days prior to the first dose of study drug

Locations (1)

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Key Dates

Start Date

September 25, 2017

Primary Completion Date

January 30, 2018

Completion Date

January 30, 2018

Last Updated

October 12, 2021

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

PDR001

DRUG

bevacizumab

DRUG

mFOLFOX6

DRUG

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

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

RECRUITINGPHASE1

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

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

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 12, 2021Data 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

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease

A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer