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NCT03190174 · ClinicalTrials.gov registry record · Phase 1

Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers

A Phase 1 study, sponsored by Sarcoma Oncology Research Center.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT03190174: Completed Phase 1 study, sponsored by Sarcoma Oncology Research Center.

NCT03190174 is a Phase 1 study that has completed, run by Sarcoma Oncology Research Center. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03190174, a Phase 1 study, has completed, sponsored by Sarcoma Oncology Research Center.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mammalian target of rapamycin (mTOR) inhibitor nab-rapamycin (ABI-009) in advanced Ewing's sarcoma, perivascular epithelioid cell tumor (PEComa), epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, high microsatellite instability (MSI-H)/ mismatch repair deficient (dMMR) metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors.

Primary Outcome

The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced dose-limiting toxicity (DLT), with the next higher dose level having at least two patients who experienced DLT.

Interventions

  • BIOLOGICAL Nivolumab
  • DRUG Nab-Rapamycin

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-08-24
Est. Completion 2021-12-02
Phase Phase 1
Sarcoma Oncology Research Center

8 total trials

What the finished NCT03190174 record still lists

NCT03190174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT03190174 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03190174 about?

NCT03190174 is a clinical study titled "Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers". This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mammalian target of rapamycin (mTOR) inhibitor nab-rapamycin (ABI-009) in advanced Ewing's sarcoma, perivascular epithelioid cell tumor (PEComa), epithe...

What is the current status of trial NCT03190174?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-08-24. Estimated completion is 2021-12-02.

What interventions are being tested in trial NCT03190174?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Nab-Rapamycin (DRUG).

Who is sponsoring clinical trial NCT03190174?

This trial is sponsored by Sarcoma Oncology Research Center, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03190174's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 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 NCT03190174, the US trial registry maintained by the National Library of Medicine. NCT03190174 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.