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NCT04551430 · ClinicalTrials.gov registry record · Phase 2

Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma

A Phase 2 study of Metastatic Soft Tissue Sarcoma, sponsored by Washington University School of Medicine.

Active
Registry status
Phase 2
Development phase
105
Enrollment target
4
Study locations

NCT04551430: Active Phase 2 study of Metastatic Soft Tissue Sarcoma, sponsored by Washington University School of Medicine.

NCT04551430 is a Phase 2 study of Metastatic Soft Tissue Sarcoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 105 participants, below the 131-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (20% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04551430, a Phase 2 study of Metastatic Soft Tissue Sarcoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
105 participants
Enrollment target
4
Study locations

Study Summary

The hypothesis of this study is that the response rate of soft tissue sarcoma will be improved with the addition of PD-1 and CTLA-4 inhibition to cabozantinib, and that cabozantinib priming will increase the response to nivolumab and ipilimumab.

Primary Outcome

* Response rate = proportion of participants who achieve complete response or partial response * Complete response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial response: At least a 30% decrease in the sum of the diameters of target lesions

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab
  • DRUG Cabozantinib

Study Locations (4)

California

  • Stanford University Medical Center - Stanford

Colorado

  • University of Colorado - Aurora

Missouri

  • Washington University School of Medicine - St Louis

Pennsylvania

  • Abramson Cancer Center at Pennsylvania Hospital - Philadelphia

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2021-01-05
Est. Completion 2029-02-01
Phase Phase 2

What the registry record for NCT04551430 still lists

NCT04551430 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 131-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (20% lower).

The record links to 1 condition, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.

NCT04551430 reports a single indexed study location in California, Colorado, Missouri.

Frequently Asked Questions

What is clinical trial NCT04551430 about?

NCT04551430 is a clinical study titled "Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma". The hypothesis of this study is that the response rate of soft tissue sarcoma will be improved with the addition of PD-1 and CTLA-4 inhibition to cabozantinib, and that cabozantinib priming will increase the response to nivolumab and ipilimumab.

What is the current status of trial NCT04551430?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2021-01-05. Estimated completion is 2029-02-01.

What conditions does trial NCT04551430 study?

This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma.

What interventions are being tested in trial NCT04551430?

The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Cabozantinib (DRUG).

Who is sponsoring clinical trial NCT04551430?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04551430 being conducted?

This trial has 4 study locations across California, Colorado, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Metastatic Soft Tissue Sarcoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04551430's enrollment target sits among peer trials

105 5th of 12 higher than 8 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04551430, the US trial registry maintained by the National Library of Medicine. NCT04551430 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.