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NCT04028063 · ClinicalTrials.gov registry record · Phase 2
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
A Phase 2 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT04028063: Recruiting Phase 2 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by University of Colorado, Denver.
NCT04028063 is a Phase 2 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 65 participants, below the 135-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04028063, a Phase 2 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a Simon two-stage design with an additional safety lead-in. The overall objective is to determine the efficacy of combination doxorubicin with dual checkpoint blockade with anti-CTLA-4 antibody AGEN1884 and anti-PD-1 antibody AGEN2034. The investigators will estimate the progression-free survival rate at 6 months (PFS6mo) of doxorubicin plus AGEN1884/AGEN2034 in comparison to historical PFS6mo with doxorubicin monotherapy, calculated as the mean from two large randomized Phase 3 clinical trials.
Primary Outcome
Determine the progression-free survival rate at 6 months of combination therapy with doxorubicin, AGEN1884, and AGEN2034 in anthracycline-naïve patients with advanced or metastatic soft tissue sarcomas.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Balstilimab
- DRUG Zalifrelimab
- DRUG Botensilimab
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT04028063 shows while recruiting
NCT04028063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 135-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (52% lower).
The record links to 2 conditions, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Doxorubicin is the first listed.
NCT04028063 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04028063 about?
NCT04028063 is a clinical study titled "Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas". This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a Simon two-stage design with an additional safety lead-in. The overall objective is to determine the efficacy of combination doxorubicin with dual checkpoint blockade with anti-CTLA-4 antibody AGEN1...
What is the current status of trial NCT04028063?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2020-01-28. Estimated completion is 2027-12-31.
What conditions does trial NCT04028063 study?
This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma.
What interventions are being tested in trial NCT04028063?
The interventions under investigation include: Doxorubicin (DRUG), Balstilimab (DRUG), Zalifrelimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT04028063?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04028063 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04028063's enrollment target sits among peer trials
65 10th of 12 higher than 3 of 12 other Metastatic Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Soft Tissue Sarcoma 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.
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