Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    70
  • sponsor
    Massachusetts General Hospital
Updated on 3 March 2022
platelet count
cancer
ascites
measurable disease
carcinoma
hepatitis
antivirals
metastasis
gemcitabine
tremelimumab
durvalumab
sorafenib
antiviral drugs
cholangiocarcinoma
biliary tract cancer

Summary

This research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer.

The interventions involved in this study are:

  • Durvalumab
  • Tremelimumab
  • Radiation Therapy

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.

The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses.

The FDA has not approved tremelimumab as a treatment for any disease.

Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system.

The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.

Details
Condition Hepatocellular Carcinoma, Biliary Tract Cancer
Treatment tremelimumab, Radiation, durvalumab
Clinical Study IdentifierNCT03482102
SponsorMassachusetts General Hospital
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
\--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
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry or brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids and anti-convulsants for at least 14-28 days prior to start of study treatment). Following radiotherapy and/or surgery of the brain metastases patients must wait 4 weeks following the intervention to confirm stability

Exclusion Criteria

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Prior irradiation to the planned radiation target lesion
Prior immunotherapy including but not limited to anti-CTLA4, including tremelimumab anti-PD-1, and anti-PD-L1, including durvalumab
Concurrent enrollment in another study unless it is an observational (e.g. non-interventional) study
Received live attenuated vaccines within 30 days of first dose
Mean QT interval corrected for heart rate (QTc) 470 ms using Fredericia's Correction
History of primary immunodeficiency
History of solid organ transplantation
Active or prior documented autoimmune disease within the past 2 years (NOTE: The following are exceptions to this criterion: Participants with vitiligo or alopecia; Participants with hypothyroidism (e.g. following Hashimoto syndrome) who are stable on hormone replacement; Participants with celiac disease controlled by diet alone: Participants with Grave's disease, or any chronic skin condition not requiring systemic treatment. Participants without active disease in the last 5 years may be included but only after consultation with the study physician.)
Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
Prior other malignancy within 2 years (except for in situ disease, which is permissible)
History of hypersensitivity to durvalumab, tremelimumab or any excipient
History of (non-infectious) pneumonitis that required steroids; or evidence of interstitial lung disease or active, non-infectious pneumonitis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
Current or prior use of immunosuppressive medication within 28 days before the first dose of treatment on this protocol, with the exceptions of
Intranasal and inhaled corticosteroids
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
Premedication for hypersensitivity reactions (e.g. to CT contrast for scans)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Subjects with uncontrolled seizures
Female subjects who are pregnant or breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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