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A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)

Study Name
A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in
ClinicalTrials.gov Identifier (if applicable)
NCT04057365
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
  • Immunotherapy
Study Center
Institution Name
Massachusetts General Hospital Cancer Center
Institution Address
55 Fruit St
City
Boston
State
Massachusetts
Zip Code
02114
Country
United States
Phone
(617) 726-2000
Website
http://www.massgeneral.org
List additional Institutions (include address, phone number, and website)
Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 02215
617-632-3000
http://www.dana-farber.org
Study Contacts
Principal Investigator
Lipika Goyal, MD
P.I. Phone
(617) 724-4000
List additional Principal Investigators (include phone number and email)
Dana- Farber Site PI:
Thomas Abrams
617-632-6932
Thomas_Abrams@dfci.Harvard.edu
Study Coordinator
Patricia Lynch
Study Coordinator Phone
(617) 643-0816
Study Coordinator Email
Lynch.Patricia2@mgh.harvard.edu
OVERVIEW – in layman’s terms (150 words max)
Patients who have already undergone another systemic therapy will be treated with DNK-01 and Nivolumab IV every two weeks.
Enrollment
30
Study Start Date
10/02/2019
Estimated Completion Date
08/31/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Evaluate how patients with advanced biliary tract cancer respond to the combination of DNK-01 and nivolumab together.
  • Evaluate how safe and tolerable it is for patients with biliary tract cancer to take both DNK-01 and nivolumab at the same time.
  • Evaluate the average amount of time patients are tumor free and survive overall while on the therapy
  • Evaluate how different genes affect the response of the tumor and overall survival of patients on therapy
  • Explore how different mutations in blood, tissue and stool relate to the treatment
Inclusion Criteria – Patients Must:
  • Intra or Extrahepatic Cholangiocarcinoma or gallbladder cancer (confirmed with tumor tissue)
  • Tumor progression on scans after at least 1 other systemic treatment for advanced biliary tract cancer. Prior secondary treatment of chemotherapy qualifies as first line if the last cycle was completed within 6 months of progression on scans
  • Have measurable tumors on scans (CT or MRI)
  • Prior treatment to the liver, if there is still tumor outside of the region that was treated or if the tumor returned
  • ECOG performance score of 0 or 1
  • Life expectancy greater than 3 months
  • Normal organ function determined through blood tests below:
  • Absolute neutrophil count ≥1,500/mcL
  • Absolute lymphocyte count ≥1.0 x 10^9/L
  • Platelets ≥75,000/mcL
  • Hemoglobin ≥ 8.0 g/dL (prior transfusions are allowed if given ≥ 7 days before testing
  • Total bilirubin < 2.0 x institutional upper limit of normal; except patients with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN
  • AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal; < 5 x ULN in case of liver metastases
  • Creatinine < 2.0 x institutional upper limit of normal OR Creatinine clearance ≥30 mL/min/1.73 m2 for participants with creatinine levels ≥ ULN
  • International Normalized Ratio (INR) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as INR is within therapeutic range of intended use of anticoagulants
  • Serum albumin > 2.5 g/dL
Exclusion Criteria – Patients Must NOT:
  • Prior DKK1 inhibior or anti PD-1/PD-L1 treatment
  • Child Pugh B or C cirrhosis
  • Non-investigational or investigational anticancer therapy within 3 weeks
  • Targeted therapy within 5 half lifes
  • Locoregional therapy within 4 weeks
  • Palliative limited field radiotherpay within 2 weeks
  • Major surgery within 4 weeks (incision must be healed)
  • Screening ECG with a Fredericia’s corrected QT interval 500 or greater
  • Known brain metastasis (not including primary tumors) unless patient is clincially stable for more than 1 month without systemic
  • Condition requiring systemic corticosteroid treatment (>2mg daily of dexamethasone equivalent) or immunosuppressive medicaiton within 14 days
  • Autoimmune disease active within the last 2 years — patients hypothyroidism on a stable thyriod hormone replacement and/or type I diabetes mellitus on a stable insulin regiment are eligible
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Physical Exam / Appointment with Doctor
  • Blood Test
  • EKG
  • CT and/or MRI
  • Pregnancy Test (women of child-bearing potential only)
  • Tumor Biopsy – if doctor feels it is safe
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Nausea
  • Vomiting
  • Decreased Appetite
  • Joint Pains
  • Fatigue
  • Itching
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