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Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03081494
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with regorafenib. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: PDR001 Drug: regorafenib Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1b study, dose escalation (N=~12) followed with an expansion (N=~60). One single arm: PDR001 in combination with regorafenib
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: PDR001 Drug: PDR001
400 mg every 4 weeks

Drug: regorafenib
either 160 or 120 or 80 mg once daily first 21 days of each 28-day cycle (=4 weeks)
Other Name: Stivarga®




Primary Outcome Measures :
  1. Incidence of Dose-limiting toxicity (DLT) [ Time Frame: 12 months ]
  2. Overall Response Rate (ORR) per investigator assessment using RECIST v1.1 [ Time Frame: 23 months ]
    RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1


Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival (OS) [ Time Frame: Every 3 months after last visit up to 1 year after last patient first treatment ]
  3. Progression free survival (PFS) [ Time Frame: Baseline, every 8 weeks until progression up to 1 year after last patient last visit ]
  4. Duration of response (DOR) [ Time Frame: Baseline, every 8 weeks until progression up to 1 year after last patient last visit ]
  5. Time to response (TTR) [ Time Frame: Baseline, every 8 weeks until progression up to 1 year after last patient last visit ]
  6. Cmax [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 21, Cycle 4 Day 1, Cycle 4 Day 21, Cycle 6 Day 1, Cycle 6 Day 21, Cycle 8 Day 21, Cycle 12 Day 1 and then every 6 cycles until end of treatment ]
  7. Area under the curve (AUC) [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 21, Cycle 4 Day 1, Cycle 4 Day 21, Cycle 6 Day 1, Cycle 6 Day 21, Cycle 8 Day 21, Cycle 12 Day 1 and then every 6 cycles until end of treatment ]
  8. Ctrough [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 21, Cycle 4 Day 1, Cycle 4 Day 21, Cycle 6 Day 1, Cycle 6 Day 21, Cycle 8 Day 21, Cycle 12 Day 1 and then every 6 cycles until end of treatment ]
  9. Antidrug antibodies (ADA) [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 8 Day 1, Cycle 10 Day 1, Cycle 12 Day 1, and then every 6 cycles until end of treatment ]


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

Key inclusion criteria:

  1. Patients with metastatic colorectal adenocarcinoma.
  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
  3. Patients must provide a newly obtained tumor tissue sample from a metastatic site
  4. Patients with the presence of at least one lesion with measurable disease as per RECIST
  5. Patients previously treated with two prior regimen as per standard of care and have experienced disease progression (including -VEGF and EGFR targeted therapies (if KRAS wild).
  6. Patient has 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 had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment
  4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti- CTLA-4 antibodies, other checkpoint inhibitors

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT03081494


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

Locations
Australia, New South Wales
Novartis Investigative Site Active, not recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Western Australia
Novartis Investigative Site Active, not recruiting
Murdoch, Western Australia, Australia, 6150
Canada, Quebec
Novartis Investigative Site Completed
Montreal, Quebec, Canada, H3T 1E2
France
Novartis Investigative Site Completed
Toulouse Cedex 9, France, 31059
Israel
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 64239
Italy
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20162
Novartis Investigative Site Withdrawn
Rozzano, MI, Italy, 20089
Japan
Novartis Investigative Site Completed
Kashiwa, Chiba, Japan, 277-8577
Korea, Republic of
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Korea, Republic of, 05505
Netherlands
Novartis Investigative Site Recruiting
Leiden, Netherlands, 2333 ZA
Singapore
Novartis Investigative Site Completed
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Completed
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Terminated
Madrid, Spain, 28040
Novartis Investigative Site Completed
Madrid, Spain, 28041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03081494     History of Changes
Other Study ID Numbers: CPDR001I2102
2017-000466-30 ( EudraCT Number )
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
regorafenib
CRC
MMS
CMS4
ElevatION:CRC-102

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