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

October 7, 2021 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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)
  4. Patients who are naïve to systemic treatment in metastatic setting. Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was completed > 12 months before inclusion.
  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

Key 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

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PDR001
Drug: PDR001
400 mg every 4 weeks
Drug: bevacizumab
5 mg/kg every 2 weeks
Drug: mFOLFOX6
Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 25, 2017

Primary Completion (ACTUAL)

January 30, 2018

Study Completion (ACTUAL)

January 30, 2018

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPDR001I2101
  • 2017-000520-96 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on PDR001

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe