Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03451773 · ClinicalTrials.gov registry record · Phase 1
M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03451773: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03451773 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03451773, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: Pancreas cancer ranks 4th in all cancer-related deaths in the United States (U.S.) Gemcitabine is a standard treatment for it. M7824 (MSB0011359C) blocks a pathway that prevents the immune system from effectively fighting cancer. The two drugs together might help people with pancreas cancer. Objective: To test if giving M7824 together with gemcitabine is safe and causes tumors to shrink. Eligibility: People ages 18 and older with pancreatic cancer already treated with standard therapies Design: Participants will be screened with: Medical history Physical exam Scans in a machine that takes pictures of the body Blood, urine, and heart tests Some participants may have a tumor sample removed. Participants will get M7824 by intravenous (IV) once every 2 weeks. They will continue until their disease gets worse or they have unacceptable side effects. After the first dose, participants will also get gemcitabine by IV once weekly for 7 weeks. Then they will get it as follows for up to 6 months: Skip 1 week, get the drug once a week for 3 weeks, skip 1 week. Before treatment on the first day of each cycle, participants will repeat screening tests. They will also have: Optional tumor biopsies before and after 3 cycles of therapy Questions about their well-being and function Genetic testing of tissue and blood samples Participants will have a follow-up visit 4-5 weeks after they stop therapy. This includes a physical exam, blood and urine tests, and maybe a scan. If their disease does not get worse, they will be invited for scans every 12 weeks.
Primary Outcome
Safety and tolerability of M7824 in combination with gemcitabine was assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v5.0. Grade 1 is mild; asymptomatic or mild symptoms. Grade 2 is moderate; minimal non-invasive intervention indicated.
Interventions
- DRUG Gemcitabine
- DRUG M7824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2020-05-05 |
| Phase | Phase 1 |
Why NCT03451773 stopped before completion
NCT03451773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT03451773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03451773 about?
NCT03451773 is a clinical study titled "M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas". Background: Pancreas cancer ranks 4th in all cancer-related deaths in the United States (U.S.) Gemcitabine is a standard treatment for it. M7824 (MSB0011359C) blocks a pathway that prevents the immune system from effectively fighting cancer. The two drugs together might help people with pancreas ca...
What is the current status of trial NCT03451773?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2018-05-17. Estimated completion is 2020-05-05.
What interventions are being tested in trial NCT03451773?
The interventions under investigation include: Gemcitabine (DRUG), M7824 (DRUG).
Who is sponsoring clinical trial NCT03451773?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03451773's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI