Metastatic Colorectal CancerPhase 1NCT03081494
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
A Phase 1 study testing spartalizumab (PDR001) and regorafenib in people with Metastatic Colorectal Cancer, run by Novartis Pharmaceuticals at 11 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- spartalizumab (PDR001) and regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 9 Jun 2017to 7 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
Australia2 sites
Novartis Investigative Site
Murdoch, Western Australia, 6150
Novartis Investigative Site
St Leonards, New South Wales, 2065
Italy2 sites
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Rozzano, MI, 20089
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28041
About this study
Official title: Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- spartalizumab (PDR001), regorafenib
- Keywords
- PDR001, MCC, immunotherapy, regorafenib, CRC, MMS, CMS4, ElevatION:CRC-102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spartalizumab (PDR001)Drug
Also called PDR001
100 mg lyophilisate in vial received 400 mg every 4 weeks
regorafenibDrug
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| spartalizumab (PDR001) + regorafenib | Experimental | Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib. Receives: Drug: spartalizumab (PDR001); Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (2)
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.
Measured: Up to 150 days after last administration of PDR001
Severity of AEs and SAEs
Severity including dose interruptions and reductions.
Measured: Up to 150 days after last administration of PDR001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start9 Jun 2017
- Primary completion7 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1b study, dose escalation (N=\~12). One single arm: PDR001 in combination with regorafenib
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081494
- Sponsor's protocol ID
- CPDR001I2102
- Other IDs
- 2017-000466-30, 2017
- Status last verified
- Dec 2020
- First submitted
- 10 Mar 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03081494
- Acronym / sponsor ID
- CPDR001I2102
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- PDR001, MCC, immunotherapy, regorafenib, CRC, MMS, CMS4, ElevatION:CRC-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1b study, dose escalation (N=~12). One single arm: PDR001 in combination with regorafenib
| Arm | Type | Receives |
|---|---|---|
| spartalizumab (PDR001) + regorafenib | Experimental | Drug: spartalizumab (PDR001), Drug: regorafenibSubjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spartalizumab (PDR001)Also: PDR001100 mg lyophilisate in vial received 400 mg every 4 weeks | Drug | spartalizumab (PDR001) + regorafenib |
| regorafenib120 mg once daily first 21 days of each 28-day cycle (=4 weeks) | Drug | spartalizumab (PDR001) + regorafenib |
Primary outcome
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.
2 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 150 days after last administration of PDR001
Severity of AEs and SAEs
Time frame: Up to 150 days after last administration of PDR001
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Novartis results databaseLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing spartalizumab (PDR001) and regorafenib in people with Metastatic Colorectal Cancer, run by Novartis Pharmaceuticals at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, Italy, Spain, Canada, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting toxicity (DLT) (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.