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Monoclonal Antibodies
DKN-01 + Nivolumab for Biliary Tract Cancer
Phase 2
Recruiting
Led By Lipika Goyal, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤1
Histologically confirmed intra- or extrahepatic cholangiocarcinoma or gallbladder cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of randomization until death, up to approximately 5 years
Awards & highlights
Study Summary
This trial is testing a new combination treatment for advanced biliary tract cancer.
Who is the study for?
Adults with advanced biliary tract cancer who have already tried at least one systemic therapy can join this trial. They must be in good health otherwise, with proper liver, kidney, and bone marrow function. Women of childbearing age need a negative pregnancy test and agree to use birth control.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Nivolumab and DKN-01. It aims to see how well they work together for patients who have previously treated advanced biliary tract cancer.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, fatigue, skin issues, digestive problems like diarrhea or nausea, potential hormonal gland problems (like thyroid), and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My cancer is confirmed to be in the bile ducts or gallbladder.
Select...
My kidney function is within the required range.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of randomization until death, up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of randomization until death, up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Median Overall Survival
Median Progression Free Survival
Side effects data
From 2013 Phase 1 trial • 32 Patients • NCT0145741732%
DYSPNOEA
21%
DECREASED APPETITE
21%
NAUSEA
21%
FATIGUE
16%
PRODUCTIVE COUGH
16%
PNEUMONIA
11%
HYPOKALAEMIA
11%
CONSTIPATION
11%
VOMITTING
5%
RESPIRATORY FAILURE
5%
SUPERIOR VENA CAVA SYNDROME
5%
ASTHENIA
5%
DYSPHAGIA
5%
VOMITING
5%
PULMONARY EMBOLISM
5%
ATRIAL FIBRILLATION
5%
PLEURAL EFFUSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
300 mg DKN-01 Part B
300 mg DKN-01 Part A
150 mg DKN-01 Part A
75 Milligram (mg) DKN-01 Part A
600 mg DKN-01 Part A
Trial Design
2Treatment groups
Experimental Treatment
Group I: DKN 01 and Nivolumab Safety Run inExperimental Treatment2 Interventions
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
Group II: DKN 01 and NivolumabExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
DKN-01
2015
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,925 Previous Clinical Trials
13,197,890 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,635 Previous Clinical Trials
4,126,849 Total Patients Enrolled
Leap Therapeutics, Inc.Industry Sponsor
15 Previous Clinical Trials
1,012 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had active autoimmune diseases like Crohn's or lupus in the last 2 years.I have allergies to medications similar to DKN-01 or Nivolumab.I have bone metastases that are osteoblastic.I have or had hepatitis C, confirmed by a test.I have ongoing nausea, vomiting, or diarrhea that my doctor finds concerning.I have a history of bone disease in my hip or significant hip issues seen on an MRI.I have had local cancer treatments like TACE or radiation within the last 4 weeks.I have been diagnosed with cancer of the ampulla of Vater.I have previously received DKK1 inhibitor or anti-PD-1/PD-L1 treatment.I have a history of specific lung conditions, but not due to radiation.I have had a stem cell or organ transplant from another person.My bile duct cancer has worsened after at least one treatment.I have chronic hepatitis B and have been on antiviral therapy for at least 4 weeks.I am a woman who cannot become pregnant or I have tested negative for pregnancy.I haven't had cancer treatment in the last 3 weeks or still have side effects.My heart condition is classified as severe but stable for the last 2 months.I have not received any live vaccines in the last 30 days.I've had treatments like chemoembolization on my liver, but my cancer can still be measured elsewhere or has grown in the treated area.I agree to use effective birth control during and after the study as required.I have brain metastasis but have been stable for over a month without high-dose steroids.I do not have any current infections.I have a family history of sudden unexplained deaths or specific heart rhythm abnormalities.I have another cancer that is active or could spread, excluding hormone-treated breast or prostate cancer.I am fully active and can carry on all my pre-disease activities without restriction.My cancer is confirmed to be in the bile ducts or gallbladder.I have had radiation for cancer spread to bones within the last 2 weeks.My kidney function is within the required range.I have had a heart attack, severe chest pain, or heart failure symptoms.I have Type 1 diabetes managed with a stable insulin routine.My blood clotting time is normal or managed if I'm on blood thinners.My organ and bone marrow functions are normal.I have an autoimmune thyroid condition but am on a stable thyroid medication.I am HIV positive.I haven't taken certain medications before starting DKN-01 and nivolumab.My liver disease is classified as Child-Pugh B or C.I haven't taken steroids or immunosuppressants in the last 14 days, except for allergy premedication.I have not had major surgery in the last 4 weeks or my surgical wound has fully healed.I am 18 years old or older.I have hepatitis B or C but meet specific health criteria.
Research Study Groups:
This trial has the following groups:- Group 1: DKN 01 and Nivolumab Safety Run in
- Group 2: DKN 01 and Nivolumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are included in this research?
"That is correct. The latest information from clinicaltrials.gov says that this study, which began recruitment on October 7th 2019, is still looking for candidates. They need 30 people total, at 2 different locations."
Answered by AI
What is the DKN-01 drug's official standing with the FDA?
"DKN-01 has not yet been proven effective, however, there is some data supporting its safety which gives it a ranking of 2."
Answered by AI
Is this research novel in any way?
"DKN-01 has a long history, with the first clinical study being performed a decade ago in 2010. The original trial was sponsored by Medarex and only involved 127 patients. DKN-01 received Phase 1 approval after this initial study. As of now, there are 747 active studies involving DKN-01 located in 2347 cities across 50 countries."
Answered by AI
Are investigators actively looking for participants for this research project?
"The trial is currently recruiting patients, as indicated by the information on clinicaltrials.gov. This study was originally posted on October 7th, 2019 and has been edited recently on January 24th, 2021."
Answered by AI
What other data is available on DKN-01?
"Currently, there are 747 clinical trials studying DKN-01. 82 of those live clinical trials are in Phase 3. While the many trials for DKN-01 are based in Basel, BE, there are 40324 locations running studies for this treatment."
Answered by AI
What is the primary reason that DKN-01 is prescribed?
"DKN-01 is most often used to treat malignant neoplasms, but it can also be prescribed for conditions like metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."
Answered by AI
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