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Trial record 1 of 1 for:    NCT03081494
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Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

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. Identifier: NCT03081494
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : December 3, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1b study, dose escalation (N=~12). 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
Actual Primary Completion Date : May 7, 2019
Actual Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: spartalizumab (PDR001) + regorafenib
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
Drug: spartalizumab (PDR001)
100 mg lyophilisate in vial received 400 mg every 4 weeks
Other Name: PDR001

Drug: regorafenib
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)

Primary Outcome Measures :
  1. Incidence of Dose-limiting toxicity (DLT) [ Time Frame: 8 Weeks ]
    A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 150 days after last administration of PDR001 ]
    Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.

  2. Severity of AEs and SAEs [ Time Frame: Up to 150 days after last administration of PDR001 ]
    Severity including dose interruptions and reductions.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT03081494

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Australia, New South Wales
Novartis Investigative Site
St Leonards, New South Wales, Australia, 2065
Australia, Western Australia
Novartis Investigative Site
Murdoch, Western Australia, Australia, 6150
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Novartis Investigative Site
Milano, MI, Italy, 20162
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Leiden, Netherlands, 2333 ZA
Novartis Investigative Site
Singapore, Singapore, 169610
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Madrid, Spain, 28041
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT03081494    
Other Study ID Numbers: CPDR001I2102
2017-000466-30 ( EudraCT Number )
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases