TY - JOUR
T1 - A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an in situ vaccine for cisplatin-ineligible MIBC
T2 - The RAD VACCINE MIBC trial
AU - Satkunasivam, Raj
AU - Lim, Kelvin
AU - Teh, Bin S.
AU - Guzman, Jonathan
AU - Zhang, Jun
AU - Farach, Andrew
AU - Chen, Shu Hsia
AU - Wallis, Christopher J.D.
AU - Efstathiou, Eleni
AU - Esnaola, Nestor F.
AU - Sonpavde, Guru P.
N1 - Funding Information:
Investigator sponsored research grant for drug (sasanlimab), Pfizer, Inc. Clinician Trialist Award, Houston Methodist Academic Institute, Houston Methodist Hospital R Satkunasivam: consultant for Intuitive Surgical, Inc.; research funding from Pfizer, Bristol-Myers Squibb, Anchiano, QED Therapeutics, Merck, CoImmune, Natera. J Zhang: honoraria and consulting/advisory role for Genentech. SH Chen: consulting/advisory role for Ansun Biopharma; patents/royalties/other intellectual property from Ansun Biopharma for self and an immediate family member. C Wallis: consulting fees from Janssen Oncology, SESEN Bio, Precision Point Specialty LLC; honoraria from EMD Serono, Haymarket Media, Healing and Cancer Foundation, Knight Therapeutics, Tolmar Pharmaceuticals Canada. E Efstathiou: consulting/advisory role for Sanofi, Janssen Oncology, Tokai Pharmaceuticals, AstraZeneca, Myovant Sci- ences, Bayer; honoraria for Sanofi, Janssen-Cilag, Astella Pharma, Takeda, Merck, Pfizer; research funding from Janssen-Cilag. NF Esnaola: consulting/advisory role for AngioDyanmics. GP Sonpavde: consulting/advisory role for Genetech, Merck, Eisai, As-traZeneca, Janssen, Bristol Myers Squibb, Exelixis, EMD Serono, Astella Pharma, Bicycle Therapeutics, Pfizer, Seattle Genetics, Gilead Sciences, Scholar Rock, G1 Therapeutics, Loxo/Lilly, Infinity Pharmaceuticals; speakers’ bureau for Physicians’ Education Resource, OncLive, Research to Practice, Medscape; travel, accommodations, expenses from Bristol Myers Squibb; honoraria for UpToDate; research funding for author’s institution from Janssen, Sanofi, AstraZeneca, Gilead Sciences, QED Therapeutics, Bristol Myers Squibb, Predicine, EMD Serono; has an immediate family member employed for Myriad Genetics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Publisher Copyright:
© 2022 Future Medicine Ltd.
PY - 2022/8
Y1 - 2022/8
N2 - The utilization of neoadjuvant immune checkpoint inhibitor therapy, specifically anti-PD-1/L1 agents, prior to radical cystectomy is an emerging paradigm in muscle-invasive bladder cancer (MIBC).
In situ vaccination represents a strategy to manipulate the tumor in order to augment the immune response toward improved local and distant cancer control. The authors describe the study rationale, design and objectives for RAD VACCINE MIBC, a single-arm, single-institution, phase II trial evaluating the efficacy and safety of combination neoadjuvant sasanlimab (humanized IgG monoclonal antibody that targets PD-1) with stereotactic body radiotherapy as an
in situ vaccine in cisplatin-ineligible patients with MIBC. The results from this trial will establish the safety profile of this combination strategy and evaluate pathologic complete response rates.
AB - The utilization of neoadjuvant immune checkpoint inhibitor therapy, specifically anti-PD-1/L1 agents, prior to radical cystectomy is an emerging paradigm in muscle-invasive bladder cancer (MIBC).
In situ vaccination represents a strategy to manipulate the tumor in order to augment the immune response toward improved local and distant cancer control. The authors describe the study rationale, design and objectives for RAD VACCINE MIBC, a single-arm, single-institution, phase II trial evaluating the efficacy and safety of combination neoadjuvant sasanlimab (humanized IgG monoclonal antibody that targets PD-1) with stereotactic body radiotherapy as an
in situ vaccine in cisplatin-ineligible patients with MIBC. The results from this trial will establish the safety profile of this combination strategy and evaluate pathologic complete response rates.
KW - PD-1 inhibitor
KW - immune checkpoint inhibition
KW - immune checkpoint inhibitor
KW - immunoradiation
KW - muscle-invasive bladder cancer
KW - muscle-invasive urothelial carcinoma
KW - sasanlimab
KW - stereotactic body radiation therapy
KW - urothelial bladder carcinoma
KW - urothelial carcinoma
KW - Immune Checkpoint Inhibitors/therapeutic use
KW - Humans
KW - Antibodies, Monoclonal, Humanized/therapeutic use
KW - Radiosurgery
KW - Cisplatin
KW - Cystectomy
KW - Vaccines/therapeutic use
KW - Neoadjuvant Therapy
KW - Combined Modality Therapy/adverse effects
KW - Clinical Trials, Phase II as Topic
KW - Urinary Bladder Neoplasms/therapy
UR - http://www.scopus.com/inward/record.url?scp=85134854946&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85134854946&partnerID=8YFLogxK
U2 - 10.2217/fon-2022-0380
DO - 10.2217/fon-2022-0380
M3 - Review article
C2 - 35703113
AN - SCOPUS:85134854946
SN - 1479-6694
VL - 18
SP - 2771
EP - 2781
JO - Future Oncology
JF - Future Oncology
IS - 25
ER -