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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176264
First Posted: June 5, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This is 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 will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: PDR001 Drug: bevacizumab Drug: mFOLFOX6 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Phase Ib study, safety run-in (N=~6 pts) followed with an expansion (N=~86 pts). One single arm: PDR001 in combination with bevacizumab and mFOLFOX6
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Incidence of Dose-limiting toxicity (DLT) [ Time Frame: 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


Secondary Outcome Measures:
  • 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 ]
  • Overall survival (OS) [ Time Frame: 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 ]
  • Duration of response (DOR) [ Time Frame: 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 ]
  • Time to response (TTR) [ Time Frame: 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 ]
  • Cmax [ Time Frame: 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 ]
  • Antidrug antibodies (ADA) [ Time Frame: Through end of treatment completion, an average of 14 months ]

Estimated Enrollment: 92
Actual Study Start Date: September 25, 2017
Estimated Study Completion Date: January 7, 2021
Estimated Primary Completion Date: January 7, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176264


Locations
Australia, New South Wales
Novartis Investigative Site
St Leonards, New South Wales, Australia, 2065
United Kingdom
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03176264     History of Changes
Other Study ID Numbers: CPDR001I2101
2017-000520-96 ( EudraCT Number )
First Submitted: May 25, 2017
First Posted: June 5, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PDR001
immunotherapy
bevacizumab
mFOLFOX6
CRC
MMS
CMS4
ElevatION;CRC-101

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents