NCT03081494

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2017

Geographic Reach
8 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

March 10, 2017

Last Update Submit

December 9, 2020

Conditions

Metastatic Colorectal Cancer

Keywords

PDR001MCCimmunotherapyregorafenibCRCMMSCMS4ElevatION:CRC-102

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 Weeks

Secondary Outcomes (2)

  • Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Up to 150 days after last administration of PDR001

  • Severity of AEs and SAEs

    Up to 150 days after last administration of PDR001

Study Arms (1)

spartalizumab (PDR001) + regorafenib

EXPERIMENTAL

Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.

Drug: spartalizumab (PDR001)Drug: regorafenib

Interventions

spartalizumab (PDR001)DRUG

100 mg lyophilisate in vial received 400 mg every 4 weeks

Also known as: PDR001
spartalizumab (PDR001) + regorafenib
regorafenibDRUG

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

spartalizumab (PDR001) + regorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Novartis Investigative Site

St Leonards, New South Wales, 2065, Australia

Location

Novartis Investigative Site

Murdoch, Western Australia, 6150, Australia

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Leiden, 2333 ZA, Netherlands

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

spartalizumabregorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase 1b study, dose escalation (N=\~12). One single arm: PDR001 in combination with regorafenib
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

June 9, 2017

Primary Completion

May 7, 2019

Study Completion

May 7, 2019

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)IL(1)NL(1)KR(1)ES(2)AU(2)CA(1)IT(2)