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NCT06545682 · ClinicalTrials.gov registry record · Phase 1

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)

A Phase 1 study of Breast Cancer and Melanoma (Skin Cancer), sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
50
Enrollment target
1
Study location

NCT06545682: Recruiting Phase 1 study of Breast Cancer and Melanoma (Skin Cancer), sponsored by M.D. Anderson Cancer Center.

NCT06545682 is a Phase 1 study of Breast Cancer and Melanoma (Skin Cancer) that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06545682, a Phase 1 study of Breast Cancer and Melanoma (Skin Cancer), is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.

Primary Outcome

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Conditions Studied

Breast Cancer Melanoma (Skin Cancer) Brain Metastasases

Interventions

  • DRUG Alpelisib + Pembrolizumab

Study Locations (1)

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-10-15
Est. Completion 2029-08-03
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What NCT06545682 shows while recruiting

NCT06545682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Alpelisib + Pembrolizumab is the first listed.

NCT06545682 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06545682 about?

NCT06545682 is a clinical study titled "Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)". To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.

What is the current status of trial NCT06545682?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-10-15. Estimated completion is 2029-08-03.

What conditions does trial NCT06545682 study?

This clinical trial studies the following conditions: Breast Cancer, Melanoma (Skin Cancer), Brain Metastasases.

What interventions are being tested in trial NCT06545682?

The interventions under investigation include: Alpelisib + Pembrolizumab (DRUG).

Who is sponsoring clinical trial NCT06545682?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06545682 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

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 NCT06545682's enrollment target sits among peer trials

50 789th of 1224 higher than 410 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer 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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More recruiting context for NCT06545682

Source: ClinicalTrials.gov NCT06545682, the US trial registry maintained by the National Library of Medicine. NCT06545682 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.