Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellu… (NCT03785210) | Clinical Trial Compass
TerminatedPhase 2
Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers
Stopped: Study was terminated due to poor accrual.
United States22 participantsStarted 2019-06-05
Plain-language summary
Background:
A most common liver cancer in adults is hepatocellular carcinoma. Other kinds of liver cancer happen when colorectal or pancreatic cancer spreads to the liver. Researchers want to study if a combination of drugs helps people with these cancers. The drugs are nivolumab, tadalafil, and vancomycin.
Objective:
To investigate if nivolumab given with tadalafil and vancomycin causes liver cancer to shrink.
Eligibility:
Adults ages 18 years and older with hepatocellular carcinoma or metastases to the liver from colorectal or pancreatic cancer for which standard treatment has not worked
Design:
Participants will be screened with:
Medical and cancer history
Review of symptoms and ability to perform normal activities
Physical exam
Heart test. Some participants may meet with a cardiologist and/or have another heart test.
Scan of the chest, abdomen, and pelvis
Blood and urine tests
Tumor sample review. This can be from a previous procedure.
Participants will receive the study drugs in 4-week cycles. In each cycle participants will:
Get nivolumab through a small plastic tube in the arm on Day 1.
Take tadalafil by mouth 1 time every day.
Take vancomycin by mouth 4 times a day. They will take it every day for weeks 1 3, then not take it for week 4.
Complete a medicine diary of dates, times, missed doses and symptoms.
Throughout the study, participants will repeat screening tests and will give stool samples or rectal swabs.
After their last cycle, participants will have 3 follow-up visits over 3 months. Then they will be contacted every 6 months by phone or email and asked about their general well-being.
...
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Patients must have
* histopathological confirmation of Hepatocellular Carcinoma (HCC) (Cohort 1) OR
* histopathological confirmation of carcinoma by in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of HCC (Cohort 1) OR
* histopathological confirmation of advanced colorectal or pancreatic malignancy with liver involvement as dominant site of metastasis (Per multidiscipline tumor board review and approval) (Cohort 2).
* Patients must have disease that is not amenable to potentially curative resection, transplantation or ablation.
* Patients must have progressed on, been intolerant to, or refused prior sorafenib/lenvatinib and/or atezolizumab/bevacizumab therapy (Cohort 1 only).
* Subjects must have progressed on or after standard systemic chemotherapy (at least one line of chemotherapy for patients with liver metastasis from pancreatic ductal adenocarcinoma (PDAC), at least two lines of chemotherapy for patients with liver metastasis from colorectal cancer (CRC) (Cohort 2 only).
* Patients must have evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Patients must have lesion accessible for biopsy and be willing to undergo pre- and posttreatment biopsies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* If liver cirrhosis is present, patient must have a Child-Pugh score less than or equal to 7
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best Overall Response (BOR)
Timeframe: Every 2 months and then every 6 months after discontinuation of treatment, for survival purposes, up to 3 years