Saci Nivo Rela for TNBC

NCT06963905 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2000037105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Triple-negative Breast Cancer

Keywords

sacituzumab govitecan; PD-L1; cytotoxic chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab

Drug: Relatlimab FDC + Nivolumab; Drug: Sacituzumab Govitecan (SG)

Arm B

ACTIVE COMPARATOR

Sacituzumab Govitecan plus nivolumab

Drug: Sacituzumab Govitecan (SG); Drug: Nivolumab

Interventions

Relatlimab FDC + Nivolumab DRUG

Relatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W

Arm A

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)

Arm A; Arm B

Nivolumab DRUG

360mg IV Q3W

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Yale University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Nivolumab; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Adriana Kahn, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kane

CONTACT

773-369-6904; Laura.Kane@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 9, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)