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

Send

Updated on 3 March 2022

See if I qualify

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 Identifier	NCT03482102
Sponsor	Massachusetts General Hospital
Last Modified on	3 March 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

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.

Learn more

Step 4 Get your study results

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

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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