Description:
This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first
line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The
study was to have assessed primarily, the safety and tolerability and then the efficacy of
PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been
paid to the level of activity of study drug combinations in CMS4 patients (retrospective
analysis).
The study was terminated early due to company decision.
Title
- Brief Title: PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
- Official Title: ElevatION: CRC-101: A Phase Ib Study of PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID:
CPDR001I2101
- SECONDARY ID:
2017-000520-96
- NCT ID:
NCT03176264
Conditions
- Metastatic Colorectal Cancer
Interventions
Drug | Synonyms | Arms |
---|
PDR001 | | PDR001 |
bevacizumab | | PDR001 |
mFOLFOX6 | | PDR001 |
Purpose
This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first
line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The
study was to have assessed primarily, the safety and tolerability and then the efficacy of
PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been
paid to the level of activity of study drug combinations in CMS4 patients (retrospective
analysis).
The study was terminated early due to company decision.
Trial Arms
Name | Type | Description | Interventions |
---|
PDR001 | Experimental | | - PDR001
- bevacizumab
- mFOLFOX6
|
Eligibility Criteria
Key inclusion criteria:
1. Patients with metastatic MSS colorectal adenocarcinoma.Note: MSI status will be
performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
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
(mandatory)
3. Patients must provide a newly obtained tumor tissue sample from a metastatic site
(mandatory)
4. Patients who are naïve to systemic treatment in metastatic setting. Patients with
previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or
investigational VEGF inhibitors) are eligible if the treatment was completed > 12
months before inclusion.
5. Patients with the presence of at least one lesion with measurable disease as per
RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered
measurable unless they have clearly progressed since the radiotherapy.
9. Patients have 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 received any systemic treatment for metastatic disease.
4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2,
anti-CTLA-4 antibodies, other checkpoint inhibitors
5. Patients who had received radiation within 14 days prior to the first dose of study
drug
Other protocol-defined inclusion/exclusion criteria may apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Dose-limiting toxicity (DLT) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1 |
Secondary Outcome Measures
Measure: | Overall response rate (ORR) per central assessment using RECIST v1.1 |
Time Frame: | Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Every 3 months after last visit up to 1 year after last patient last visit |
Safety Issue: | |
Description: | |
Measure: | Progression free survival |
Time Frame: | Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR) |
Time Frame: | Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit |
Safety Issue: | |
Description: | |
Measure: | Time to response (TTR) |
Time Frame: | Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit |
Safety Issue: | |
Description: | |
Measure: | Ctrough |
Time Frame: | Through end of treatment completion, an average of 14 months |
Safety Issue: | |
Description: | |
Measure: | Cmax |
Time Frame: | Through end of treatment completion, an average of 14 months |
Safety Issue: | |
Description: | |
Measure: | Area under the curve (AUC) |
Time Frame: | Through end of treatment completion, an average of 14 months |
Safety Issue: | |
Description: | |
Measure: | Antidrug antibodies (ADA) |
Time Frame: | Through end of treatment completion, an average of 14 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- PDR001
- immunotherapy
- bevacizumab
- mFOLFOX6
- CRC
- MMS
- CMS4
- ElevatION;CRC-101
Last Updated
December 8, 2020