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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
spartalizumab (PDR001)
regorafenib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring PDR001, MCC, immunotherapy, regorafenib, CRC, MMS, CMS4, ElevatION:CRC-102

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spartalizumab (PDR001) + regorafenib

Arm Description

Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.

Outcomes

Primary Outcome Measures

Incidence of Dose-limiting toxicity (DLT)
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

Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.
Severity of AEs and SAEs
Severity including dose interruptions and reductions.

Full Information

First Posted
March 10, 2017
Last Updated
December 9, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03081494
Brief Title
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Official Title
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
PDR001, MCC, immunotherapy, regorafenib, CRC, MMS, CMS4, ElevatION:CRC-102

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Phase 1b study, dose escalation (N=~12). One single arm: PDR001 in combination with regorafenib
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spartalizumab (PDR001) + regorafenib
Arm Type
Experimental
Arm Description
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
Intervention Type
Drug
Intervention Name(s)
spartalizumab (PDR001)
Other Intervention Name(s)
PDR001
Intervention Description
100 mg lyophilisate in vial received 400 mg every 4 weeks
Intervention Type
Drug
Intervention Name(s)
regorafenib
Intervention Description
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)
Primary Outcome Measure Information:
Title
Incidence of Dose-limiting toxicity (DLT)
Description
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.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Description
Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.
Time Frame
Up to 150 days after last administration of PDR001
Title
Severity of AEs and SAEs
Description
Severity including dose interruptions and reductions.
Time Frame
Up to 150 days after last administration of PDR001

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria: Patients with metastatic colorectal adenocarcinoma. Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis Patients must provide a newly obtained tumor tissue sample from a metastatic site Patients with the presence of at least one lesion with measurable disease as per RECIST 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). Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Key exclusion criteria: Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing Patients with metastatic disease amenable to be resected with potentially curative surgery Patients who have had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti- CTLA-4 antibodies, other checkpoint inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Novartis Investigative Site
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17553
Description
Novartis results database
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=553
Description
A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

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

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