NCT03609424

Brief Summary

Assuming that PDR001, an anti-PD-1 antibody, with imatinib might be effective in advanced GIST after failure of standard TKI therapies including imatinib, sunitinib, and regorafenib. In this phase I/II study of PDR001 plus imatinib, it is aimed to evaluate the safety and efficacy of this regimen as 4th line of treatment in advanced GIST.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

July 25, 2018

Last Update Submit

December 30, 2022

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose

    Primary Outcome of phase Ib part

    up to 12 weeks

  • Recommended dose for expansion

    Primary Outcome of phase Ib part

    up to 12 weeks

  • Disease control rate

    Disease control rate (DCR: objective response + stable disease) at 12 weeks Primary Outcome of phase 2 part(defined by RECIST v1.1)

    up to 12 weeks

Secondary Outcomes (6)

  • Progression-free survival

    Up to 2 years

  • Overall survival

    Up to 2 years

  • Response rate

    Up to 2 years

  • Toxicity profile

    Up to 2 years

  • Correlation of efficacy with potential biomarkers

    Up to 2 years

  • +1 more secondary outcomes

Study Arms (1)

PDR001 plus Imatinib

EXPERIMENTAL
Drug: PDR001, Imatinib

Interventions

PDR001, ImatinibDRUG

-Phase Ib part : The standard 3+3 dose escalation scheme will be applied. DLTs will be evaluated during the first cycle (4 weeks). PDR001 400mg, every 4 weeks, IV Imatinib dose level -1 : 200mg, PO, QD Imatinib dose level 1 : 300mg, PO, QD Imatinib dose level 2 : 400mg, PO, QD -Phase II part * Recommended dose defined in phase Ib part will be tested

PDR001 plus Imatinib

Eligibility Criteria

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

You may not qualify if:

  • Patients who are intolerant to imatinib
  • Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Clinically significant and/or uncontrolled heart disease such as congestive heart failure (CHF) requiring treatment (NYHA grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia
  • Congenital long QT syndrome
  • QTc\> 470 msec on screening ECG
  • Unstable angina pectoris ≤ 3 months prior to starting study drug
  • Acute Myocardial Infarction ≤ 3 months prior to starting study drug
  • Uncontrolled infection
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • Active autoimmune disease or a documented history of autoimmune disease, or any condition that requires systemic steroids, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators (e.g., albuterol).
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study
  • Major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy
  • Known diagnosis of HIV infection (HIV testing is not mandatory)
  • History of another primary malignancy that is currently clinically significant or currently requires active intervention
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

spartalizumabImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Yoon-Koo Kang, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

February 14, 2019

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations

KR(1)