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A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Clinical Trial Details

The purpose of this study is to test the good and bad effects of a drug called M3814 in combination with the drug avelumab and radiation therapy for advanced/metastatic solid tumors and hepatobiliary malignancies.

M3814 in combination with avelumab and radiation therapy is considered investigational because it is not yet approved by the U.S. Food and Drug Administration (FDA) for this use. Although M3814 and avelumab have been used to treat cancer, it is not yet known if the combination of M3814 with avelumab and radiation therapy will work to treat advanced/metastatic hepatobiliary cancer.

Participants who take part in this study will be randomized and either get radiation therapy followed by a combination of avelumab and M3814, or radiation therapy followed by avelumab. Avelumab is given via a vein in the arm and M3814 is taken orally via tablets.

Participants will receive study treatment until their disease gets worse, or the side effects become too severe. After finishing the combination of M3814 and avelumab, the study doctor and team will continue to monitor participants for up to 5 years and watch for side effects

Key Eligibility: 
  1. Open to men and women aged 18 and older who have a confirmed diagnosis of metastatic or locally advanced unresectable cholangiocarcinoma/gallbladder carcinoma. 
  2. Participants must not be pregnant or nursing and must agree to use contraception.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Marie Stefania
646-962-3541
mgs4003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2111024126

ClinicalTrials.gov:

NCT04068194

Sponsor:

10276

Status

Open to Enrollment

Age Group

Adult

Sponsor