Clinical Trials /

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

NCT03081494

Description:

This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability of PDR001 in combination with regorafenib.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CPDR001I2102
  • SECONDARY ID: 2017-000466-30
  • NCT ID: NCT03081494

Conditions

  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
PDR001PDR001
regorafenibStivarga®PDR001

Purpose

This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with regorafenib. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

Trial Arms

NameTypeDescriptionInterventions
PDR001Experimental
  • PDR001
  • regorafenib

Eligibility 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

        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 first treatment
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:Baseline, every 8 weeks until progression 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 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 up to 1 year after last patient last visit
Safety Issue:
Description:
Measure:Cmax
Time Frame:Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 21, Cycle 4 Day 1, Cycle 4 Day 21, Cycle 6 Day 1, Cycle 6 Day 21, Cycle 8 Day 21, Cycle 12 Day 1 and then every 6 cycles until end of treatment
Safety Issue:
Description:
Measure:Area under the curve (AUC)
Time Frame:Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 21, Cycle 4 Day 1, Cycle 4 Day 21, Cycle 6 Day 1, Cycle 6 Day 21, Cycle 8 Day 21, Cycle 12 Day 1 and then every 6 cycles until end of treatment
Safety Issue:
Description:
Measure:Ctrough
Time Frame:Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 21, Cycle 4 Day 1, Cycle 4 Day 21, Cycle 6 Day 1, Cycle 6 Day 21, Cycle 8 Day 21, Cycle 12 Day 1 and then every 6 cycles until end of treatment
Safety Issue:
Description:
Measure:Antidrug antibodies (ADA)
Time Frame:Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 8 Day 1, Cycle 10 Day 1, Cycle 12 Day 1, and then every 6 cycles until end of treatment
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • PDR001
  • immunotherapy
  • regorafenib
  • CRC
  • MMS
  • CMS4
  • ElevatION:CRC-102

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