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NCT06963905 · ClinicalTrials.gov registry record · Phase 1
Saci Nivo Rela for TNBC
A Phase 1 study of Metastatic Triple-Negative Breast Cancer, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06963905 is a Phase 1 study of Metastatic Triple-Negative Breast Cancer that is actively recruiting participants, run by Yale University. The registered enrollment target is 60 participants, below the 80-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06963905, a Phase 1 study of Metastatic Triple-Negative Breast Cancer, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, open-label, phase Ib study to assess safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with any programmed cell death-ligand 1 (PD-L1) status metastatic, triple negative breast cancer on routine testing with one prior line of cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. The study treatment will be continued until the progression of disease, unacceptable toxicity, death, or withdrawal of consent for any reason.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Sacituzumab Govitecan (SG)
- DRUG Relatlimab FDC + Nivolumab
Study Locations (1)
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-12-29 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06963905
The ClinicalTrials.gov registry entry for NCT06963905 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (25% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT06963905 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT06963905 about?
NCT06963905 is a clinical study titled "Saci Nivo Rela for TNBC". This is a randomized, open-label, phase Ib study to assess safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with any programmed cell death-ligand 1 (PD-L1) status metastatic, triple negative bre...
What is the current status of trial NCT06963905?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-12-29. Estimated completion is 2030-12.
What conditions does trial NCT06963905 study?
This clinical trial studies the following conditions: Metastatic Triple-Negative Breast Cancer.
What interventions are being tested in trial NCT06963905?
The interventions under investigation include: Nivolumab (DRUG), Sacituzumab Govitecan (SG) (DRUG), Relatlimab FDC + Nivolumab (DRUG).
Who is sponsoring clinical trial NCT06963905?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06963905 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.