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

Phase 1

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: PDR001; Drug: bevacizumab; Drug: mFOLFOX6

• Registration Number: NCT03176264
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2017-09-25
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDR001	PDR001	-
PDR001	mFOLFOX6	-
PDR001	bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) per investigator assessment using RECIST v1.1	19 months	RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1
Incidence of Dose-limiting toxicity (DLT)	12 months

Secondary Outcome Measures

Name	Time	Method
Cmax	Through end of treatment completion, an average of 14 months
Duration of response (DOR)	Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Disease control rate (DCR)	Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Time to response (TTR)	Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Ctrough	Through end of treatment completion, an average of 14 months
Area under the curve (AUC)	Through end of treatment completion, an average of 14 months
Overall response rate (ORR) per central assessment using RECIST v1.1	Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Overall survival (OS)	Every 3 months after last visit up to 1 year after last patient last visit
Progression free survival	Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Antidrug antibodies (ADA)	Through end of treatment completion, an average of 14 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Sutton, Surrey, United Kingdom