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NCT03785210 · ClinicalTrials.gov registry record · Phase 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
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT03785210: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03785210 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785210, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study 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. ...
Interventions
- DRUG nivolumab
- DRUG tadalafil
- DRUG oral vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03785210
The ClinicalTrials.gov registry entry for NCT03785210 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which nivolumab is the first listed.
NCT03785210 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03785210 about?
NCT03785210 is a clinical study titled "Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers". 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 va...
What is the current status of trial NCT03785210?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2019-06-05. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03785210?
The interventions under investigation include: nivolumab (DRUG), tadalafil (DRUG), oral vancomycin (DRUG).
Who is sponsoring clinical trial NCT03785210?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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