Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04057365
Phase
PHASE2
Status
Terminated

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab is believed to work by attaching to and inhibiting a specific protein in the cancer that controls parts of the immune system (the system in the body that fights off infections and diseases) by shutting down certain immune responses. The investigators believe that nivolumab will inhibit the protein, thus allowing the immune cells to recognize and destroy cancer cells.
  • DKN-01 — DRUG
    DKN-01 is believed to work by attaching to and inhibiting (stopping) a specific pathway in the cells that is responsible for processes such as cell growth

Study Details

This research is studying the effect of the combination of how two study drugs (Nivolumab and DKN-01) works in people with advanced biliary tract cancer.

Key Dates

Start date
Oct 7, 2019
Status verified
Aug 2025
Primary completion
Sep 25, 2022
Completion
Sep 25, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DKN 01 and Nivolumab Safety Run in
    * DKN-01 will be administered intravenously on day 1 and day 15 of each 28 day cycle * Nivolumab will be administered intravenously on day 1 and day 15 of each 28 day cycle
  • Experimental: DKN 01 and Nivolumab
    * DKN-01 will be administered intravenously on day 1 and day 15 of each 28 day cycle * Nivolumab will be administered intravenously on day 1 and day 15 of each 28 day cycle

Primary Outcome Measure

Overall Response Rate [ Time Frame: up to 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

Related Studies