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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: Recruiting Phase 1 study of Metastatic Triple-Negative Breast Cancer, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure is the incidence of dose-limiting toxicities (DLTs) observed three weeks after the first cycle of treatment with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination in patients with advanced triple-negative breast cancer in the second-line setting. The assessment will include the frequency and severity of DLTs to evaluate the safety and tolerability of the treatment regimens.
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 |
What NCT06963905 shows while recruiting
NCT06963905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 80-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (25% lower).
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 a single indexed study location in 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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