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NCT03007407 · ClinicalTrials.gov registry record · Phase 2
Study of Durvalumab and Tremelimumab After Radiation for Microsatellite Stable Metastatic Colorectal Cancer Progressing on Chemotherapy
A Phase 2 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT03007407: Completed Phase 2 study, sponsored by NSABP Foundation.
NCT03007407 is a Phase 2 study that has completed, run by NSABP Foundation. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03007407, a Phase 2 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune system to destroy the cancer cells. In order to learn more about certain characteristics of colorectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, fresh tumor samples from an area where the cancer has spread, and blood samples.
Primary Outcome
Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be \<10mm on the short axis. Partial Response (PR): 30% or more decrease in the sum of diameters of target lesions. The reference the baseline sums of diameters. Progressive Disease (PD): 20% or more increase in the sum of diameters of target lesions. The reference is the smallest sum while on study (including the baseline sum if that is the smallest on study). In additi
Interventions
- DRUG durvalumab
- DRUG Tremelimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2019-08-09 |
| Phase | Phase 2 |
What the finished NCT03007407 record still lists
NCT03007407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which durvalumab is the first listed.
NCT03007407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03007407 about?
NCT03007407 is a clinical study titled "Study of Durvalumab and Tremelimumab After Radiation for Microsatellite Stable Metastatic Colorectal Cancer Progressing on Chemotherapy". This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific prot...
What is the current status of trial NCT03007407?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2017-07-31. Estimated completion is 2019-08-09.
What interventions are being tested in trial NCT03007407?
The interventions under investigation include: durvalumab (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT03007407?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03007407's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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