Study on Durvalumab and Tremelimumab for Treating Advanced Rare Solid Tumors

Sponsor: Prisma Health-Upstate

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02938793

Provider View

This clinical trial is testing a combination of two drugs, Durvalumab and Tremelimumab, to see if they are safe and effective in treating people with certain advanced rare solid tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of Durvalumab and Tremelimumab works in treating advanced rare solid tumors. Researchers are looking at the safety and effectiveness of these drugs when used together. The study is open-label, meaning both the researchers and participants know which treatment is being given. The trial is currently in the phase where it is expanding to include more participants with specific types of rare tumors, except for certain soft tissue sarcomas, neuroendocrine tumors, and thymic carcinoma, which are not included.

Description

This study is focused on understanding how the combination of two drugs, Durvalumab and Tremelimumab, can help treat advanced rare solid tumors. The trial is being conducted at a single institution and is open-label, meaning that both the researchers and participants know what treatment is being administered. The study has two phases: the dose-exploration phase, which has been completed, and the dose-expansion phase, which is ongoing. The current phase includes participants with specific rare tumors, excluding certain soft tissue sarcomas, neuroendocrine tumors, and thymic carcinoma.

Participants will receive Durvalumab at a dose of 1500 mg every four weeks for 13 doses, and Tremelimumab at a dose of 300 mg as a single dose on the first day of the first cycle. For participants weighing less than 30 kg, the doses will be adjusted based on their weight. Tremelimumab will be given first, followed by Durvalumab about an hour later, with each infusion lasting about an hour.

The study uses data from the RARECARE project, which collected information on rare cancers across Europe, to define what constitutes a rare cancer for this trial. Rare cancers are those with an incidence of less than 6 cases per 100,000 people per year.

Eligibility Criteria

Inclusion Criteria

  • Have a diagnosis of a rare advanced solid tumor that meets specific criteria.
  • Have tried and not responded to standard treatments, or be ineligible for them.
  • Be willing to have a tumor biopsy or have recent tumor samples available.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have a life expectancy of more than 3 months.
  • Have normal organ and bone marrow function, including:
    • Hemoglobin level above 9.0 g/dl.
    • Neutrophil count above 1500 per mm3.
    • Platelet count above 100,000 per mm3.
    • Bilirubin level less than 1.5 times the upper limit of normal (ULN).
    • ALT/AST levels less than 2.5 times ULN, or less than 5 times ULN if liver metastases are present.
    • Creatinine clearance above 40 ml/min.

Exclusion Criteria

  • Have previously been treated with Durvalumab or Tremelimumab.
  • Have received any checkpoint inhibitor treatments before.
  • Have rare cancers that are being studied in other trials, such as thymic carcinoma, certain sarcomas, and neuroendocrine tumors.
  • Have untreated cancer that has spread to the brain.
  • Have an active or documented autoimmune disease in the past 2 years.
  • Have uncontrolled psoriasis.
  • Have had chemotherapy within 28 days before starting the study drugs.
  • Have used steroids within 28 days before starting the study drugs, except for certain low-dose or inhaled steroids.

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