Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
NCT ID: NCT03081494
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2017-06-09
2019-05-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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spartalizumab (PDR001) + regorafenib
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
spartalizumab (PDR001)
100 mg lyophilisate in vial received 400 mg every 4 weeks
regorafenib
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)
Interventions
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spartalizumab (PDR001)
100 mg lyophilisate in vial received 400 mg every 4 weeks
regorafenib
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
St Leonards, New South Wales, Australia
Novartis Investigative Site
Murdoch, Western Australia, Australia
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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Related Links
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Novartis results database
A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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2017-000466-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CPDR001I2102
Identifier Type: -
Identifier Source: org_study_id