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Clinical Trial 19935

Cancer Type: Gastrointestinal Tumor

Study Type: Treatment
Phase of Study: Phase II

  • Richard Kim

Call 813-745-6100
or 1-800-679-0775

Study Title

A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or are Intolerant to First-line Platinum-Based Chemotherapy



Primary: To evaluate clinical efficacy of M7824 based on ORR. Secondary: To evaluate clinical efficacy of M7824 based on duration of response (DOR) - To evaluate clinical efficacy of M7824 based on durable response rate (DRR) - To evaluate clinical safety of M7824

Inclusion Criteria

  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
  • Availability of tumor (primary or metastatic) archival material or fresh biopsies (collected within 28 days before first administration) of study intervention is mandatory
  • Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy
  • Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
  • Life expectancy >= 12 weeks as judged by the Investigator
  • Adequate hematological function defined by white blood cell (WBC) count >= 3 * 10^9/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 10^9/Litre, platelet count >=75 * 10^9/Litre, and hemoglobin (Hgb) >= 9 grams/decilitre
  • Adequate hepatic function defined by a total bilirubin level =>Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =>Albumin >= 3.0 grams/decilitre
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
  • Adequate renal function defined by either creatinine = 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
  • Other protocol defined inclusion criteria could apply

  • Exclusion Criteria

  • Ampullary cancer is excluded
  • Significant acute or chronic infections
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Interstitial lung disease or its history
  • Participants who are not eligible for or have not been treated with 1L systemic chemotherapy
  • Anticancer treatment within 21 days before the start of study intervention
  • Concurrent treatment with nonpermitted drugs
  • Prior participation in a M7824 clinical trial
  • Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
  • Pregnancy or breast feeding
  • Other protocol defined exclusion criteria could apply