Clinical Trials /

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

NCT03081494

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Completed

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
spartalizumab (PDR001)PDR001spartalizumab (PDR001) + regorafenib
regorafenibspartalizumab (PDR001) + regorafenib

Purpose

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 Arms

NameTypeDescriptionInterventions
spartalizumab (PDR001) + regorafenibExperimentalSubjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
  • spartalizumab (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
      
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:8 Weeks
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame:Up to 150 days after last administration of PDR001
Safety Issue:
Description:Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.
Measure:Severity of AEs and SAEs
Time Frame:Up to 150 days after last administration of PDR001
Safety Issue:
Description:Severity including dose interruptions and reductions.

Details

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

Trial Keywords

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

Last Updated

December 11, 2020