RECRUITING

Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma

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Conditions

Locally Advanced Intrahepatic CholangiocarcinomaOligometastatic Intrahepatic CholangiocarcinomaStage III Intrahepatic Cholangiocarcinoma AJCC v8Stage IV Intrahepatic Cholangiocarcinoma AJCC v8Unresectable Intrahepatic Cholangiocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial tests the safety and side effects of yttrium-90 (Y90) radioembolization combined with immunotherapy drugs tremelimumab and durvalumab in treating patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts in the liver) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) who are not candidates for curative therapy or that has spread from where it first started (primary side) to multiple other places in the body (oligo-metastatic). Cholangiocarcinoma is a rare but aggressive cancer with limited curative options outside of surgery. Immunotherapy has shown modest benefit in hepatobiliary (liver, bile ducts, and gallbladder) cancers including cholangiocarcinoma. Radioembolization is a type of radiation therapy used to treat liver cancer that is advanced or has come back where tiny beads that hold the radioactive substance (radioisotope) yttrium Y90 are injected into or near the hepatic artery (the main blood vessel that carries blood to the liver). The beads collect in the tumor and the Y90 gives off radiation. This destroys the blood vessels that the tumor needs to grow and kills the tumor cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Y90 radioembolization in combination with tremelimumab and durvalumab immunotherapy may be safe and beneficial in treating patients with locally advanced, unresectable or oligo-metastatic intrahepatic cholangiocarcinoma who are not candidates for curative therapy.

Official Title

Phase 1 Trial of Safety and Preliminary Efficacy of Segmental Ablative Radioembolization in Combination With Tremelimumab Plus Durvalumab (MEDI4736) in Patients With Unresectable, or Oligo-Metastatic Cholangiocarcinoma Who Are Not Candidates for Curative Therapy (RAIDEN Trial)

Quick Facts

Study Start:2024-06-06
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06058663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years with body weight \> 30 kg
  2. * Histologically or cytologically confirmed, locally advanced intrahepatic cholangiocarcinoma that is not amenable to resection, transplantation, or thermal ablation. Oligometastatic intrahepatic cholangiocarcinoma is also eligible. Specifically, such patients must have EITHER =\< 3 malignant extrahepatic lymph nodes (short axis diameter \>= 3cm) OR metastatic lesions in one organ other than liver (if only single lesion is present diameter MUST be \< 3cm, if up to 3 lesions in one organ each lesion MUST be =\< 1cm)
  3. * Measurable disease
  4. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  5. * Hemoglobin \>= 9.0 g/dL (=\< 14 days prior to registration)
  6. * Absolute neutrophil count (ANC) \>= 1000/mm\^3 (=\< 14 days prior to registration)
  7. * Platelet count \>= 75,000/mm\^3 (=\< 14 days prior to registration)
  8. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (patients with known Gilbert disease who have serum bilirubin level 3 x ULN may be enrolled) (=\< 14 days prior to registration)
  9. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 5 x ULN (=\< 14 days prior to registration)
  10. * Calculated creatinine clearance \>= 40 ml/min using the Cockcroft- Gault formula or measured creatinine clearance \> 40 ml/min (=\< 14 days prior to registration)
  11. * International normalized ratio (INR) =\< 1.6. Note: INR prolongation due
  12. * Anticoagulation (INR \>= 2.0 but =\< 3.0)) for prophylaxis in patients without liver cirrhosis could be exception
  13. * Adequate hepatic function Child Pugh A and albumin-bilirubin (ALBI) 1 or 2
  14. * Patients with concurrent hepatitis B (HBV) or hepatitis C virus (HCV) infection should meet the following criteria:
  15. * Patient with HBV or should be monitored for viral levels during study participation
  16. * Patient with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should have HBV DNA \< 100 IU/ml and should be managed per local guidelines
  17. * Controlled hepatitis B subjects will be allowed if they have started treatment prior to or by the time point of enrollment into the study and treatment is continued during study participation and for \>= 6 months after end of study treatment
  18. * Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  19. * Negative urine pregnancy test done prior =\< 7 days registration, for persons of childbearing potential only
  20. * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  1. * Concurrent enrollment in another clinical study, unless it is an observational clinical study or during the follow up period of an interventional study
  2. * Surgery =\< 28 days prior to registration
  3. * Chemotherapy =\< 4 weeks prior to registration
  4. * History of \> 1 prior systemic therapy for cholangiocarcinoma not including that in the adjuvant setting. Patients who progressed during or =\< 6 months from completion of adjuvant therapy are excluded
  5. * Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \>= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  6. * Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
  7. * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
  8. * History of previous locoregional therapy
  9. * Previous use of therapeutic cancer vaccines
  10. * Unstable liver function and/ or a change in Child Pugh score during screening
  11. * Child Pugh B or greater
  12. * ALBI grade \> 2
  13. * Model for End-Stage Liver Disease (MELD) \> 10
  14. * Patient is unable to undergo mapping angiography or mapping angiography demonstrates tumor blood supply that does not lend itself to transarterial therapy
  15. * A lung shunt fraction greater than 30 Gy within a single session, or cumulative does greater than 50Gy
  16. * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  17. * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  18. * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  19. * Active or uncontrolled autoimmune or inflammatory disorders (including Inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, granulomatosis with polyangiitis, sarcoidosis, Grave's disease)
  20. * History of another primary malignancy except for:
  21. * Malignancy treated with curative intent and with no known active disease \>= 5 years prior to registration and of low potential of recurrence
  22. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  23. * Adequately treated carcinoma in situ without evidence of disease
  24. * Uncontrolled intercurrent illness including, but not limited to:
  25. * Ongoing uncontrolled infections including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), human immunodeficiency virus (HIV), hepatitis B and hepatitis C
  26. * Serious chronic gastrointestinal condition associated with diarrhea
  27. * Symptomatic congestive heart failure
  28. * Unstable angina pectoris, cardiac arrhythmia and uncontrolled hypertension
  29. * Chronic pulmonary disease including interstitial lung disease requiring oxygen
  30. * Psychiatric illness/social situations limiting compliance that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
  31. * Uncontrolled hypertension
  32. * History of leptomeningeal carcinomatosis
  33. * Presence of pulmonary metastases measuring 1 cm or greater or other extra-nodal metastatic disease
  34. * History of allogeneic transplantation
  35. * Current or prior use of immunosuppressive medication \< 14 days before registration. The following are exceptions to this criterion:
  36. * Intranasal, inhaled, topical steroids, or local steroid injections
  37. * Systemic corticosteroids at physiologic doses not to exceed 10mg/day of
  38. * Prednisone or its equivalent
  39. * Known allergy or hypersensitivity to durvalumab and tremelimumab or any of the constituents of the products
  40. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  41. * Pregnant or lactating female
  42. * Life expectancy \< 3 months
  43. * Intolerance to contrast agents that is refractory to medical management
  44. * Any other condition which the investigator believes would make participation in the study not acceptable
  45. * History of primary immunodeficiency
  46. * Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts
  47. * Receipt of live attenuated vaccine \< 30 days prior to registration and without need to receive any live attenuated vaccines during study conduct and for up to 30 days after end of durvalumab treatment or 90 days after end of tremelimumab treatment respectively
  48. * Prior immunotherapy including prior treatment with an anti-programmed death receptor-1 (PD-1), anti-programmed death-1ligand-1 (PD-L1), including durvalumab anti-PD-L2, or anti-cytotoxic T-lymphocyte associated antigen-4 (anti-CTLA-4) antibody, including tremelimumab

Contacts and Locations

Principal Investigator

Umair Majeed, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Umair Majeed, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-06
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-06-06
Study Completion Date2025-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Intrahepatic Cholangiocarcinoma
  • Oligometastatic Intrahepatic Cholangiocarcinoma
  • Stage III Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
  • Unresectable Intrahepatic Cholangiocarcinoma