Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy ≥ 3 months
  • At least one measurable lesion as assessed by RECIST 1.1
  • Adequate organ and marrow function
  • Adequate contraception
  • Patients with either of the following:
    • Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible.
    • Pathologically confirmed metastatic or unresectable cholangiocarcinoma or GBC with progression of disease after first-line chemotherapy and immunotherapy.

• Key Exclusion Criteria

  A patient will not be eligible if any of the following criteria applies:

  • Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
    • Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
    • Active infection (viral, fungal, or bacterial) requiring systemic therapy
    • Known active hepatitis B virus, hepatitis C virus, or HIV infection
    • Active tuberculosis as defined per local guidance
    • History of allogeneic tissue/solid organ transplant
    • Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
    • Pregnant or breastfeeding
    • Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
  • History or clinical evidence of symptomatic central nervous system (CNS) metastases
  • For first-line cholangiocarcinoma, active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with Type 1 diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.