| ClinicalTrials.gov Identifier |
| NCT04057365 |
| Institution Name |
| Massachusetts General Hospital Cancer Center |
| Institution Address (Street) |
| 55 Fruit St |
| Institution City |
| Boston |
| Institution State |
| Massachusetts |
| Institution ZIP Code |
| 02114 |
| Institution Country |
| United States |
| Institution Phone |
| (617) 726-2000 |
| Institution Website |
| http://www.massgeneral.org |
| Additional Institutions |
|
| Principal Investigator |
| Lipika Goyal, MD |
| Principal Investigator Phone |
| (617) 724-4000 |
| Additional Principal Investigators |
|
| Study Coordinator |
| Patricia Lynch |
| Study Coordinator Phone |
| (617) 643-0816 |
| Study Coordinator Email |
| Lynch.Patricia2@mgh.harvard.edu |
| Study Overview |
| Patients who have already undergone another systemic therapy will be treated with DNK-01 and Nivolumab IV every two weeks. |
| Enrollment Information |
| 30 |
| Study Start Date |
| 20191002 |
| Study End Date |
| 20240831 |
| Study Purpose |
- 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 |
- 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 |
- 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 Study |
- 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 |
- Nausea
- Vomiting
- Decreased Appetite
- Joint Pains
- Fatigue
- Itching
|
| Financial Assistance Available |
| No |
