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PhII Combo Atelizumab&CDX-1127 w/ or w/o Add of Cobimetinib in Prev Treated Unresec Biliary Tract Ca

Farshid Dayyani


A Study On:

  • Liver
  • Small Intestine
  • Pancreas

Status:

  • Open

Eligibility

Adult

Interested in joining this trial?

Official Title

A Randomized Phase II Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers

Details

The purpose of this study is to test a novel combination of anti-cancer medications that we hope will boost your immune system’s ability to find and fight your cancer, called immunotherapy. Specifically, this study will evaluate any good and bad effects of using a combination of two types of antibody immunotherapies, atezolizumab and CDX-1127 (varlilumab), with or without another anti-cancer drug called cobimetinib.

Atezolizumab and CDX-1127 (varlilumab) together could help to shrink your cancer. Adding cobimetinib to atezolizumab and CDX-1127 (varlilumab) could help to shrink your cancer further, but it could also cause extra side effects, which are described in the risks section below. This study will allow the researchers to know whether atezolizumab and CDX-1127 (varlilumab) plus cobimetinib is better, the same, or worse than using the combination atezolizumab and CDX-1127 (varlilumab) alone.

The drugs, atezolizumab and cobimetinib, are already FDA-approved for treating other cancers, but they have not been studied in this kind of cancer. CDX-1127 (varlilumab) is another type of immunotherapy that is still in clinical trials and is not currently FDA-approved for biliary or other cancer types.

Another purpose of this study is for researchers to learn more about how the study drugs might affect the immune system to help fight your cancer.


Eligibility

You can join if...

Inclusion Criteria:

  • Patient must have pathologically confirmed biliary tract cancer, having received at least 1 prior line of systemic therapy, and no more than 2 prior lines of therapy in the metastatic setting
  • Patient must be willing to undergo 2 sets of core needle biopsies
  • Patient must be able to swallow pills

Exclusion Criteria:

  • Patients with prior allogeneic bone marrow transplantation within the past 5 years or prior organ transplantation
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from side effects from treatments administered more than 4 weeks earlier
  • History of allergic reactions to similar chemical or biological compositions to atezolizumab, cobimetinib, and CDX-1127 (varlilumab)

Get in touch with our study team