Phase 2 Study of Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory CD30 Positive T-cell Lymphoma
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What is the purpose of this trial?
This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of ~65%. Pembrolizumab and brentuximab will be administered for 16 cycles in patients with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. Dose adjustments for specific toxicities with either drugs are detailed in the protocol. Based on statistical analysis 43 subjects will need to be accrued to evaluate for disease response based on historical control.
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Principal Investigator
Sub-Investigators
- Adam Boruchov, MD
- Agatha Hecht
- Alessia Donadio, MD
- Alexis Walker
- Alfredo Axtmayer
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Brooke Chaves
- Caitlin Sullivan
- Carrie Fijal, MSN, AGPCNP-BC, OCN
- Catherine Wei, MD
- D. Barry Boyd, MD, MS
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Elizabeth Cappiello
- Emily Collier, MD
- Ethan Kohn
- Francesca Montanari, MD
- Francine Foss, MD
- Harold Tara Jr, MD
- Iris Isufi, MD
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jean Vollmer
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Kaitlin Brown
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Karishma Mehra, MBBS
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kelsey Martin, MD
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Larisa Fleysher
- Leena Rahmat
- M. Sung Lee, MD
- Madeline Santiago
- Matthew Austin, MD
- Michael Cohenuram, MD
- Michael Grant, MD
- Neal Fischbach, MD
- Nicholas Blondin, MD
- Pawan Karanam, MD
- Renee Moye
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Thomen, APRN
- Scott Huntington, MD, MPH, MSc
- Shalin Kothari, MD
- Sharynn Hall, MD, PhD
- Stacey LaRosa
- Stephen Lattanzi, MD
- Stuart Seropian, MD
- Su Hsien Lim, MD
- Sudhanshu Mulay, MD
- Syed Ali
- Syed Bilgrami, MBBS
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Zia Rahman, MD
- Last Updated11/14/2024
- Study HIC#2000029793