Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer
Volunteers
Health Professionals
What is the purpose of this trial?
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 programmed cell death-ligand 1 (PD-L1) positive (defined by combined positive score >10), metastatic, triple negative breast cancer on routine testing with one prior line of cytotoxic chemotherapy with pembrolizumab 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.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Anca Bulgaru, MD
- Andrea Brennan, PA
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS, MD
- Benjamin Newton, MD
- Carlotta C. Evans, APRN
- Claire Aurilio
- Clarice Grens, APRN
- D. Barry Boyd, MD, MS
- Elan Gorshein, DO, JD, MPH
- Elizabeth Gaa, APRN
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham, APRN
- Ian Krop, MD, PhD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Jing Du, MD, PhD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katelyn Scott, APRN
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kathryn Mason, APRN
- Kert Sabbath, MD, FACP
- Lajos Pusztai, MD, DPhil
- Larisa Fleysher, APRN
- Laura Sabourin
- Madeline Santiago
- Mariya Rozenblit, MD
- Maryam Lustberg, MD, MPH
- Matthew Austin, MD
- Melissa Gambaccini, APRN, AOCNP, FNPC, APRN
- Michael DiGiovanna, MD, PhD
- Michael Grant, MD
- Michelle Corso, APRN
- Neal Fischbach, MD
- Pawan Karanam, MD
- Rebecca Vanasse-Passas, MD
- Robert Legare, MD
- Sara Anastasio, APRN, RN
- Sarah Carlson, PA
- Sarah Thomen, APRN
- Sarah Elizabeth Schellhorn, MD
- Sharynn Hall, MD, PhD
- Stacey LaRosa, APRN
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy, APRN
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated03/22/2026
- Study IRB#2000037105