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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03081494




Registration number
NCT03081494
Ethics application status
Date submitted
10/03/2017
Date registered
16/03/2017
Date last updated
3/12/2019

Titles & IDs
Public title
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Scientific title
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
Secondary ID [1] 0 0
2017-000466-30
Secondary ID [2] 0 0
CPDR001I2102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - spartalizumab (PDR001)
Treatment: Drugs - regorafenib

Experimental: spartalizumab (PDR001) + regorafenib - Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.


Treatment: Drugs: spartalizumab (PDR001)
100 mg lyophilisate in vial received 400 mg every 4 weeks

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
8 Weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 150 days after last administration of PDR001
Secondary outcome [2] 0 0
Severity of AEs and SAEs - Severity including dose interruptions and reductions.
Timepoint [2] 0 0
Up to 150 days after last administration of PDR001

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec
Country [2] 0 0
Israel
State/province [2] 0 0
Tel Aviv
Country [3] 0 0
Italy
State/province [3] 0 0
MI
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Korea
Country [5] 0 0
Netherlands
State/province [5] 0 0
Leiden
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
Spain
State/province [7] 0 0
Catalunya
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03081494
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications