CompletedPhase 1/2

PDR001 Plus Imatinib for Metastatic or Unresectable GIST

South Korea39 participantsStarted 2019-02-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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:
✕. 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

What they're measuring

Maximum tolerated dose

Timeframe: up to 12 weeks

Recommended dose for expansion

Timeframe: up to 12 weeks

Disease control rate

Timeframe: up to 12 weeks

Trial details

NCT IDNCT03609424

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-11

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumors trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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:
✕. 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