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NCT05741164 · ClinicalTrials.gov registry record · Phase 2

Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer

A Phase 2 study, sponsored by Emory University.

Recruiting
Registry status
Phase 2
Development phase
37
Enrollment target

NCT05741164: Recruiting Phase 2 study, sponsored by Emory University.

NCT05741164 is a Phase 2 study that is actively recruiting participants, run by Emory University. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05741164, a Phase 2 study, is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 2
Development phase
37 participants
Enrollment target

Study Summary

This phase II trial tests how well propranolol and pembrolizumab work to cause tumor re-sensitization and therefore treatment in patients with triple negative breast cancer that has not responded to previous checkpoint inhibitor therapy (refractory), cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Propranolol is a drug that is classified as a beta-blocker. Beta-blockers affect the heart and circulation. Beta-blockers, like propranolol, may help to counteract effects of certain stress hormones produced by the body during cancer treatment and may increase the effectiveness of the pembrolizumab. Pembrolizumab is a drug that is classified as an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Propranolol may be able to re-sensitize the cells of the immune system to respond to the checkpoint inhibitor pembrolizumab in patients with checkpoint inhibitor refractory metastatic or unresectable triple negative breast cancer.

Primary Outcome

Efficacy as determined by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Will be summarized using frequencies and relative frequencies. The best response within the first 6 months will be determined as the best objective response.

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • DRUG Propranolol

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2024-09-01
Est. Completion 2029-06-30
Phase Phase 2
Emory University

1,208 total trials

What NCT05741164 shows while recruiting

NCT05741164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05741164 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05741164 about?

NCT05741164 is a clinical study titled "Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer". This phase II trial tests how well propranolol and pembrolizumab work to cause tumor re-sensitization and therefore treatment in patients with triple negative breast cancer that has not responded to previous checkpoint inhibitor therapy (refractory), cannot be removed by surgery (unresectable) or ha...

What is the current status of trial NCT05741164?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2024-09-01. Estimated completion is 2029-06-30.

What interventions are being tested in trial NCT05741164?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Propranolol (DRUG).

Who is sponsoring clinical trial NCT05741164?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05741164's enrollment target sits among peer trials

37 1484th of 2000 higher than 505 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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Source: ClinicalTrials.gov NCT05741164, the US trial registry maintained by the National Library of Medicine. NCT05741164 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.