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NCT03116529 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma

A Phase 1 study, sponsored by University of Maryland, Baltimore.

Terminated
Registry status
Phase 1
Development phase
22
Enrollment target

NCT03116529: Clinical Trial Phase 1 study, sponsored by University of Maryland, Baltimore.

NCT03116529 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03116529, a Phase 1 study, was terminated before completion, sponsored by University of Maryland, Baltimore.

TERMINATED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

Chemotherapy is controversial for soft tissue sarcoma that has not yet metastasized. Surgery and radiation are effective for local control, but there are no highly effective interventions to prevent metastatic spread of soft tissue sarcoma. Immunotherapy has shown promise in other types of cancer. Combining two types of immunotherapy agents with preoperative radiation may help the immune system recognize the sarcoma and stimulate an anti-tumor immune response.

Primary Outcome

Number of subjects experiencing high-grade toxicity

Interventions

  • COMBINATION_PRODUCT Combination Radiation, Immunotherapy, Surgery

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2017-06-21
Est. Completion 2024-06-21
Phase Phase 1
University of Maryland, Baltimore

560 total trials

Why NCT03116529 stopped before completion

NCT03116529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 1 intervention - of which Combination Radiation, Immunotherapy, Surgery is the first listed.

NCT03116529 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03116529 about?

NCT03116529 is a clinical study titled "Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma". Chemotherapy is controversial for soft tissue sarcoma that has not yet metastasized. Surgery and radiation are effective for local control, but there are no highly effective interventions to prevent metastatic spread of soft tissue sarcoma. Immunotherapy has shown promise in other types of cancer. C...

What is the current status of trial NCT03116529?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-06-21. Estimated completion is 2024-06-21.

What interventions are being tested in trial NCT03116529?

The interventions under investigation include: Combination Radiation, Immunotherapy, Surgery (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT03116529?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03116529's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 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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Source: ClinicalTrials.gov NCT03116529, the US trial registry maintained by the National Library of Medicine. NCT03116529 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.