Trial · NCT06963905
Saci Nivo Rela for TNBC
NCT06963905, Phase 1, Phase 2, Recruiting, Yale University
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Saci Nivo Rela for TNBC. Trials, record NCT06963905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06963905
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Saci Nivo Rela for TNBC
- NCT number
- NCT06963905
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Yale University
- Conditions
- Metastatic Triple-negative Breast Cancer
- Interventions
- Relatlimab FDC + Nivolumab, Sacituzumab Govitecan (SG), Nivolumab
- First posted
- 2025-05-09
- Last updated
- 2026-05-22
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations | Three weeks post-Cycle 1 Day 1 (each cycle is 21 days) | 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. |
| Secondary | Time to response in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | Time to Response is defined as the time from the initiation of treatment to the first documentation of a complete response or partial response in patients with advanced TNBC in the second-line setting. This outcome measure will assess the efficacy of sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC, by measuring how quickly patients respond to the therapy.. |
| Secondary | Overall response rate in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | The Overall Response Rate is defined as the proportion of patients with advanced triple-negative breast cancer in the second-line setting who achieve either a complete response or partial response according to the RECIST version 1.1. The ORR will be assessed in patients receiving sacituzumab govitecan combined with nivolumab, or sacituzumab govitecan combined with nivolumab and relatlimab fixed-dose combination (FDC). This outcome measure aims to evaluate the preliminary efficacy of the treatment regimens. |
| Secondary | Duration of response in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | The Duration of Response is defined as the time from the first documentation of a complete response or partial response until the time of disease progression or death from any cause, whichever occurs first. This measure will be evaluated in patients with advanced TNBC in the second-line setting who respond to treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. The objective is to determine the sustainability of the responses induced by the treatment combinations. |
| Secondary | Clinical benefit rate in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | The Clinical Benefit Rate is defined as the proportion of patients who achieve a complete response, partial response, or stable disease for at least 6 months, according to RECIST version 1.1. This measure will be assessed in patients with advanced TNBC in the second-line setting undergoing treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. The CBR will help determine the overall efficacy and potential benefit of the treatment regimens. |
| Secondary | Progression free survival in patients treated with sacituzumab govitecan combinations | At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion | Progression-Free Survival is defined as the time from the start of treatment to the occurrence of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to the RECIST version 1.1. This outcome measure will evaluate the preliminary efficacy of the treatment regimens involving sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination (FDC) in patients with advanced triple-negative breast cancer (TNBC) in the second-line setting. The intent is to determine how effectively these treatment combinations can delay disease progression and extend the time patients remain progression-free. |
| Secondary | Incidence of adverse events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The incidence of adverse events will be assessed in patients with advanced triple-negative breast cancer in the second-line setting receiving treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab fixed-dose combination (FDC). Adverse events will be recorded and graded according to NCI CTCAE version 5.0. |
| Secondary | Frequency of serious adverse events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The frequency of serious adverse events will be monitored and documented in patients treated with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC. SAEs will be classified and graded according to the NCI CTCAE version 5.0 criteria. |
| Secondary | Incidence of Treatment-Emergent Adverse Events in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | Treatment-emergent adverse events will be defined and assessed as any adverse events that arise following the initiation of treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. TEAEs will be graded according to the NCI CTCAE version 5.0 criteria. |
| Secondary | Incidence of Adverse Events of Special Interest in patients treated with sacituzumab govitecan combinations | Days 1 and 8 of every 21-day cycle and at the last follow up visit, 30 days after the last treatment cycle or upon study completion | The incidence of adverse events of special interest will be recorded and evaluated in patients receiving treatment with sacituzumab govitecan combinations. AESIs will include specific adverse events deemed critical based on the known safety profile of the drugs, and will be graded according to the NCI CTCAE version 5.0 criteria. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06963905
GET https://conductscience.org/api/trials/v1/NCT06963905/registered