Metastatic Triple-negative Breast CancerPhase 1/2SIMONENCT06963905
Saci Nivo Rela for TNBC
A Phase 1/2 study testing Relatlimab FDC + Nivolumab, Sacituzumab Govitecan (SG) and Nivolumab in people with Metastatic Triple-negative Breast Cancer, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Triple-negative Breast Cancer
- What is being tested?
- Relatlimab FDC + Nivolumab, Sacituzumab Govitecan (SG) and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2025to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be competent and able to comprehend, sign, and date an IRB approved ICF before the performance of any study specific procedures or tests.
- Participants 18 years or older.
- Pathologically documented breast cancer that:
- Is defined as unresectable/metastatic disease.
- Is Human Epidermal Growth Factor Receptor 2 (HER2)-negative, defined as HER2- immunohistochemistry (IHC) 0, 1+ or 2+ ISH negative, and estrogen receptor (ER)- and progesterone receptor (PgR)- negative, both defined as IHC <10%
- Any PD-L1 status measured by IHC via CPS by IHC (defined by the number of PD-L1 staining cells [tumor cells, lymphocytes, macrophages] divided by the total number of viable tumor cells, multiplied by 100) via FDA-approved SP263 assay.
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- Has been treated with up to one line of systemic cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. If recurrence occurred within six months of (neo)adjuvant chemotherapy, (neo)adjuvant chemotherapy would count as one line of therapy.
- Prior immune checkpoint inhibition with systemic chemotherapy is required in either neo(adjuvant) or metastatic settings
- Prior targeted therapies (e.g., olaparib, or others upon discussion with study sponsor-investigator) do not count as systemic cytotoxic chemotherapy lines and are unlimited prior to enrolment.
- Documented radiologic progression (during or after most recent treatment) or intolerance to prior line of therapy regardless of prior response with subsequent medical need for change of therapy.
- Must have an adequate archival tumor sample <3 years old available for exploratory analyses. If archival tissue is not available or inadequate for assessment (e.g., decalcified bone, cytology, or other), a new tissue biopsy is required on enrolment.
- Presence or absence of measurable lesion-based Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 are both allowed.
- ECOG PS 0 or 1.
- Left ventricular ejection fraction (LVEF) ≥50% within 6 months prior to enrolment.
- Adequate laboratory parameters (table 1) within 14 days from C1D1
- Adequate contraception when indicated (table 2), such as:
- Evidence of post-menopausal status or negative serum pregnancy test for participants of childbearing potential who are sexually active with a non-sterilized male partner.
- For participants of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of study drugs.
- Participants of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- Participants of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in table 3, from the time of screening and must agree to continue using such precautions for seven months after the last dose of study drugs.
- Female participants must refrain from breastfeeding while on study and for seven months after the last dose of study drugs.
- Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least seven months after the final study drug administration. Preservation of ova may be considered prior to enrolment in this study.
- Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the participant's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.
- Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use a condom from screening to five months after the final dose of study drugs.
- Male participants should refrain from fathering a child or freezing or donating sperm from the time of enrolment, throughout the study, and for five months after the last dose of study drugs. Preservation of sperm should be considered prior to enrolment in this study.
Who cannot join
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Participants who are pregnant or lactating.
- Participants of childbearing potential or fertile men unwilling to use effective contraception.
- Certain prior comorbidities, such as:
- Concomitant metastatic disease from other primary tumors.
- Known history of unstable angina, MI, or CHF present within six months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
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- History of myocarditis.
- Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within six months of randomization.
- History of (non-infectious) pneumonitis or interstitial pulmonary disease that required steroids for more than 28 consecutive days or has current pneumonitis or interstitial pulmonary disease.
- Prior history of GI perforation within six months of randomization.
- Has an uncontrolled infection requiring current IV antibiotics, antivirals, or antifungals.
- Has known human immunodeficiency virus (HIV) infection with detectable viral load or CD4 count < 200 cells per cubic millimeter or active hepatitis B (HBsAg positive) or C (HCV positive RNA) infection.
- Any active autoimmune, connective tissue or inflammatory disorders that required active immunomodulatory or corticosteroid treatments in the two years prior to study enrolment. Participants with active autoimmune diseases may enroll with the following conditions: type 1 diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
- Certain central nervous system conditions, such as:
- Has currently untreated spinal cord compression.
- Has clinically active central nervous system metastases, defined as symptomatic, or requiring therapy with corticosteroids to control associated symptoms.
- Participants with clinically asymptomatic brain metastases not requiring corticosteroids and seizure-free for more than 30 days with or without prior local therapy administration (surgery and/or radiation therapy) may be included in the study.
- Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the investigator (e.g., grade 2 chemotherapy-induced neuropathy, fatigue, residual endocrinopathies from use of immunotherapy such as hypothyroidism/hyperthyroidism, type 1 diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)).
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
- Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Participants must not have had prior treatment with relatlimab or any other LAG-3 targeted agent, as well as no prior SG or other TROP2-ADCs..
- Substance abuse, medical conditions, social, familial, or geographical factors that would, in the opinion of the investigator, increase the safety risk to the participant or interfere with the participant's participation in the clinical study or evaluation of the clinical study results despite best use of locally and community available resources.
- Adequate washout period from prior therapies before C1D1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Carl Brown, 2037854095, carl.brown@yale.edu
About this study
Official title: Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for Patients With Metastatic Triple Negative Breast Cancer
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.
Read the detailed description
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. Patients will be followed up for up to two years. Their safety will be monitored, and tumor response will be regularly evaluated by RECIST 1.1 criteria every nine weeks. The primary endpoint includes safety as the incidence of dose-limiting toxicities (DLT) in three weeks after C1D1. Secondary endpoints include overall response rate (defined as either complete response or partial response), duration of response, clinical benefit rate, progression free survival, and safety (TEAE) with sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus nivolumab + relatlimab FDC. Exploratory endpoints include overall survival, and biomarkers of prediction of response will be also evaluated. There will be a 135-day (+7 days) follow-up visit after the last study treatment administration or before starting a new anticancer treatment, whichever occurs first, followed by long-term/survival chart review follow-up every three months (±14 days) from the date of the 135-day (+7 days) follow-up visit for two years.
- Conditions
- Metastatic Triple-negative Breast Cancer
- Being tested
- Relatlimab FDC + Nivolumab, Sacituzumab Govitecan (SG), Nivolumab
- Keywords
- sacituzumab govitecan, PD-L1, cytotoxic chemotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relatlimab FDC + NivolumabDrug
Relatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W
Sacituzumab Govitecan (SG)Drug
10 mg/kg IV D1 \& D8 every 21-day cycles (Dose level 1); 7.5 mg/kg IV D1 \& D8 every 21-day cycles (Dose level -1); 5 mg/kg IV D1 \& D8 every 21-day cycles 21-day cycles (Dose level -2)
NivolumabDrug
360mg IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab Receives: Drug: Relatlimab FDC + Nivolumab; Drug: Sacituzumab Govitecan (SG) |
| Arm B | Active comparator | Sacituzumab Govitecan plus nivolumab Receives: Drug: Sacituzumab Govitecan (SG); Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations
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.
Measured: Three weeks post-Cycle 1 Day 1 (each cycle is 21 days)
Secondary outcomes (14)
Time to response in patients treated with sacituzumab govitecan combinations
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..
Measured: 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
Overall response rate in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Duration of response in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Clinical benefit rate in patients treated with sacituzumab govitecan combinations
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.
Measured: 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 in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Incidence of adverse events in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Frequency of serious adverse events in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Incidence of Treatment-Emergent Adverse Events in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Incidence of Adverse Events of Special Interest in patients treated with sacituzumab govitecan combinations
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.
Measured: 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
Incidence of Immune-Mediated Adverse Events in patients treated with sacituzumab govitecan combinations
The occurrence of immune-mediated adverse events will be monitored in patients treated with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC. imAEs will be assessed and graded according to NCI CTCAE version 5.0 criteria to describe the immune-related safety profile of the treatment regimens.
Measured: 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
Rate of Treatment Discontinuation Due to Adverse Events in patients treated with sacituzumab govitecan combinations
The rate at which patients discontinue treatment due to adverse events will be assessed. This measure will monitor the proportion of patients with advanced TNBC in the second-line setting who cease treatment with sacituzumab govitecan combinations due to AEs. AEs leading to discontinuation will be documented and graded according to NCI CTCAE version 5.0 criteria.
Measured: 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
Changes in ECOG Performance Status in patients treated with sacituzumab govitecan combinations
The changes in Eastern Cooperative Oncology Group (ECOG) Performance Status will be evaluated at baseline and periodically during treatment to assess the impact of sacituzumab govitecan combinations on patients' functional status. The ECOG Performance Status scale will be utilized to categorize patient performance levels.
Measured: 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
Electrocardiogram abnormalities in patients treated with sacituzumab govitecan combinations
Electrocardiogram (ECG) assessments will be conducted to monitor for any treatment-related cardiac abnormalities in patients receiving sacituzumab govitecan combinations. Any significant ECG changes and their clinical relevance will be documented.
Measured: Days 1 and 8 of every 21-day cycle
Echocardiogram findings in patients treated with sacituzumab govitecan combinations
Echocardiogram (ECHO) assessments will be performed to evaluate cardiac function and detect any cardiotoxicity associated with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. ECHO findings will be analyzed for any significant changes from baseline.
Measured: Days 1 and 8 of every 21-day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start29 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Adriana Kahn, Yale University
- Investigators
- Adriana Kahn, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963905
- Sponsor's protocol ID
- 2000037105
- Acronym
- SIMONE
- Status last verified
- May 2026
- First submitted
- 2 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for Patients With Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06963905
- Acronym / sponsor ID
- SIMONE / 2000037105
- Conditions
- Metastatic Triple-negative Breast Cancer
- Keywords
- sacituzumab govitecan, PD-L1, cytotoxic chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Patients will be followed up for up to two years. Their safety will be monitored, and tumor response will be regularly evaluated by RECIST 1.1 criteria every nine weeks. The primary endpoint includes safety as the incidence of dose-limiting toxicities (DLT) in three weeks after C1D1. Secondary endpoints include overall response rate (defined as either complete response or partial response), duration of response, clinical benefit rate, progression free survival, and safety (TEAE) with sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus nivolumab + relatlimab FDC. Exploratory endpoints include overall survival, and biomarkers of prediction of response will be also evaluated. There will be a 135-day (+7 days) follow-up visit after the last study treatment administration or before starting a new anticancer treatment, whichever occurs first, followed by long-term/survival chart review follow-up every three months (±14 days) from the date of the 135-day (+7 days) follow-up visit for two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Relatlimab FDC + Nivolumab, Drug: Sacituzumab Govitecan (SG)Sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab |
| Arm B | Active comparator | Drug: Sacituzumab Govitecan (SG), Drug: NivolumabSacituzumab Govitecan plus nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Must be competent and able to comprehend, sign, and date an IRB approved ICF before the performance of any study specific procedures or tests.
- Participants 18 years or older.
- Pathologically documented breast cancer that:
- Documented radiologic progression (during or after most recent treatment) or intolerance to prior line of therapy regardless of prior response with subsequent medical need for change of therapy.
- Must have an adequate archival tumor sample <3 years old available for exploratory analyses. If archival tissue is not available or inadequate for assessment (e.g., decalcified bone, cytology, or other), a new tissue biopsy is required on enrolment.
Key exclusion criteria (24 listed)
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Participants who are pregnant or lactating.
- Participants of childbearing potential or fertile men unwilling to use effective contraception.
- Certain prior comorbidities, such as:
- Certain central nervous system conditions, such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relatlimab FDC + NivolumabRelatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W | Drug | Arm A |
| Sacituzumab Govitecan (SG)10 mg/kg IV D1 \& D8 every 21-day cycles (Dose level 1); 7.5 mg/kg IV D1 \& D8 every 21-day cycles (Dose level -1); 5 mg/kg IV D1 \& D8 every 21-day cycles 21-day cycles (Dose level -2) | Drug | Arm A, Arm B |
| Nivolumab360mg IV Q3W | Drug | Arm B |
Primary outcome
Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations
Time frame: 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.
14 secondary outcomes
Time to response in patients treated with sacituzumab govitecan combinations
Time frame: 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
Overall response rate in patients treated with sacituzumab govitecan combinations
Time frame: 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
Duration of response in patients treated with sacituzumab govitecan combinations
Time frame: 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
Clinical benefit rate in patients treated with sacituzumab govitecan combinations
Time frame: 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 in patients treated with sacituzumab govitecan combinations
Time frame: 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
Incidence of adverse events in patients treated with sacituzumab govitecan combinations
Time frame: 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
Frequency of serious adverse events in patients treated with sacituzumab govitecan combinations
Time frame: 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
Incidence of Treatment-Emergent Adverse Events in patients treated with sacituzumab govitecan combinations
Time frame: 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
Incidence of Adverse Events of Special Interest in patients treated with sacituzumab govitecan combinations
Time frame: 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
Incidence of Immune-Mediated Adverse Events in patients treated with sacituzumab govitecan combinations
Time frame: 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
Rate of Treatment Discontinuation Due to Adverse Events in patients treated with sacituzumab govitecan combinations
Time frame: 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
Changes in ECOG Performance Status in patients treated with sacituzumab govitecan combinations
Time frame: 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
Electrocardiogram abnormalities in patients treated with sacituzumab govitecan combinations
Time frame: Days 1 and 8 of every 21-day cycle
Echocardiogram findings in patients treated with sacituzumab govitecan combinations
Time frame: Days 1 and 8 of every 21-day cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriana Kahn, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Relatlimab FDC + Nivolumab, Sacituzumab Govitecan (SG) and Nivolumab in people with Metastatic Triple-negative Breast Cancer, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Kane (773-369-6904, Laura.Kane@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations (time frame: Three weeks post-Cycle 1 Day 1 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.