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NCT04214418 · ClinicalTrials.gov registry record · Phase 1
Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT04214418: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT04214418 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04214418, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This research study is for patients with an advanced cancer that carries a mutation in a gene called KRAS. Genes are parts of our DNA which carry instructions for a cell (the smallest component of an body part). In many cancers, the KRAS gene contains errors (mutations) which allows the tumors to grow. The purpose of this study is to determine if combination treatment with atezolizumab, cobimetinib, and hydroxychloroquine is safe, and if it will decrease the size of the tumor and prolong life in patients whose tumors contain this mutation. Cobimetinib and atezolizumab are both approved by the FDA for use in other cancers, but not in some cancer types being studied in this trial. Hydroxychloroquine is FDA approved to treat malaria and other conditions, but has also not been approved for these cancer types. Preliminary results have shown that this combination of drugs is effective at killing cancer cells and shrinking tumors in several KRAS-mutated cancers in animals.
Primary Outcome
The MTD is defined as the dose combination at which 30% of the patients experience a dose-limiting toxicity (DLT) by the end of Cycle 2
Interventions
- DRUG Atezolizumab
- DRUG Cobimetinib
- DRUG Hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2022-07-01 |
| Phase | Phase 1 |
Why NCT04214418 stopped before completion
NCT04214418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Atezolizumab is the first listed.
NCT04214418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04214418 about?
NCT04214418 is a clinical study titled "Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies". This research study is for patients with an advanced cancer that carries a mutation in a gene called KRAS. Genes are parts of our DNA which carry instructions for a cell (the smallest component of an body part). In many cancers, the KRAS gene contains errors (mutations) which allows the tumors to gr...
What is the current status of trial NCT04214418?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2020-02-12. Estimated completion is 2022-07-01.
What interventions are being tested in trial NCT04214418?
The interventions under investigation include: Atezolizumab (DRUG), Cobimetinib (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT04214418?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04214418's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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
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