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NCT03101566 · ClinicalTrials.gov registry record · Phase 2
Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT03101566 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 75 participants.
The verdict
NCT03101566, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the effect of investigational drug nivolumab in combination with either gemcitabine/cisplatin chemotherapy, or in combination with another investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer. Gemcitabine/cisplatin is the standard of care treatment for biliary tract cancer. Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo) is FDA approved for the treatment of several cancers including metastatic melanoma, advanced lung, kidney, head \& neck and bladder cancer. The combination of nivolumab and ipilimumab (Yervoy) is FDA approved for metastatic melanoma.
Interventions
- DRUG Cisplatin
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-09-08 |
| Est. Completion | 2021-06-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03101566
The ClinicalTrials.gov registry entry for NCT03101566 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT03101566 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03101566 about?
NCT03101566 is a clinical study titled "Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer". The purpose of this trial is to evaluate the effect of investigational drug nivolumab in combination with either gemcitabine/cisplatin chemotherapy, or in combination with another investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer. Gemcitabine/cisplatin is ...
What is the current status of trial NCT03101566?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2017-09-08. Estimated completion is 2021-06-07.
What interventions are being tested in trial NCT03101566?
The interventions under investigation include: Cisplatin (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03101566?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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