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Phase 1/2 Study of Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder - (ADAPT-BLADDER)

Funder: National Cancer Institute

Funding period
USD 657 K
Funding amount
Abstract
Project Summary: Over 81,000 new individuals are diagnosed each year with urothelial carcinoma (UC) of the bladder and 17,000 will die from their disease. Most have non-muscle invasive disease (NMIBC) at diagnosis. Despite standard treatment with the live, attenuated mycobacterial strain Bacillus Calmette-Guerin (BCG) instilled into the bladder, two-thirds of NMIBC patients will develop relapsed tumors after BCG treatment. While curative, cystectomy is associated with life-altering quality of life impact and is not feasible, or is refused, in many. Nonsurgical curative options for BCG-relapsing NMIBC patients are lacking. In metastatic UC, durable responses with low toxicity rates have been observed with checkpoint inhibitor (CPI) therapies aimed at the programmed cell death protein 1 (PD-1) / programmed death-ligand 1 (PD-L1) pathway leading to the FDA approval of five agents. Examining novel combination approaches including CPIs in BCG-relapsing NMIBC represents a natural next step. In this proposal, we plan to define the safety and clinical activity, assess the point-of-care diagnostic potential of several genomic biomarker platforms, and perform initial mechanistic investigations of novel combinations of CPI therapy with both BCG and radiation in the multi-arm, multi-stage ADAPT-BLADDER phase 1b/2 clinical trial, with the long-term goal of informing the design of future practice-changing phase 3 trials. Objectives: 1) To demonstrate safety and clinical efficacy of immunotherapy combination regimens in patients with BCG-relapsing NMIBC; 2) To identify conserved candidate genomic signatures associated with clinical benefit and/or treatment resistance to novel immunotherapy regimens in NMIBC patients with recurrent tumors after prior BCG therapy; 3) To demonstrate the existence of tumor antigen-specific T-cell responses and correlate such responses with clinical outcomes to novel immunotherapy regimens in NMIBC patients with recurrent tumors after prior BCG therapy. Methods: We will assess each objective prospectively through the multi-center phase 1 b / 2 ADAPT- BLADDER trial in over 170 patients with BCG-relapsing NMIBC. Specifically, we will document the safety of each regimen in phase 1 and clinical efficacy in phase 2. We will correlate baseline and post- treatment genomic biomarker signatures with clinical benefit. Lastly, we will interrogate the ability of personalized neoantigen peptide libraries to expand antigen-specific T-cell clones. We hypothesize that immunotherapy combination regimens will be safe and effective. Moreover, we anticipate the identification of point-of-care genomic biomarker signatures that can distinguish patients most likely to benefit; we expect to identify novel gene expression signatures predictive of therapy response and resistance; and we suspect the planned functional tumor immunology investigations will yield illuminating discoveries.

 
218
Projects
USD 142.0 M
Aggregated funding amount
USD 855 K
Average funding amount
Project list item
Geriatric Conditions and Treatment Burden in Older Adults with Non-Muscle-Invasive Bladder Cancer and Their Caregivers

National Institute on Aging to TULLIKA GARG

USD 135,849
2019 - 2021
Project list item
Transdifferentiation of fibroblasts to urothelial progenitors for definitive urothelial replacement therapy in non-muscle invasive bladder cancer

Bladder Cancer Advocacy Network to Philip A Beachy, Kris Butalid Prado

USD 300,000
2019 - 2021
Project list item
Targeting FGF in Bladder cancer after Neoadjuvant Immunotherapy and Surgery

American Association For Cancer Research to Joshua James Meeks

USD 25,000
2019 - 2020
Project list item
Biomarker-Based Tools for Treatment Response Decision Support of Bladder Cancer

National Cancer Institute to LUBOMIR M HADJIYSKI, AJJAI SHIVARAM ALVA

USD 653,319
2019 - 2024
Project list item
Combatting Bladder Cancer by Inducing Epithelial Turnover

National Cancer Institute to SOMAN N ABRAHAM

USD 203,510
2019 - 2021
Project list item
Development of an automated method to capture bladder cancer recurrence and progression for epidemiologic research

National Cancer Institute to KIM N DANFORTH

USD 172,270
2019 - 2021
Project list item
Defining the impact of intra-tumoral morphologic, immune and mutational heterogeneity in urothelial carcinoma

National Cancer Institute to HIKMAT AL-AHMADIE

USD 410,835
2019 - 2024
Project list item
A revolutionary shape memory alloy-based disposable device for bladder cancer removal

European Commission

USD 57,207
2019 - 2019
Project list item
Clonal evolution and molecular stratification of urothelial carcinoma in situ of the urinary bladder

German Research Foundation to Stefan Garczyk, Nadine Gaisa

 
2019 -
Project list item
The role of a new molecular driver in bladder cancer

National Cancer Institute to DALEY MORERA

USD 45,016
2018 - 2021
Project list item
Modulation of regulatory T cells in the bladder tumor environment by anti-PD-L1 immunotherapy

Bladder Cancer Advocacy Network to David Yoonsuk Oh, Lawrence Fong

USD 50,000
2018 - 2019
Project list item
Identifying DNA Biomarkers of Bacillus Calmette-Guerin (BCG) Resistance in Non-Muscle-Invasive Bladder Cancer

Canadian Institutes of Health Research to Jack Victor Warren Bacon, Alexander William Wyatt

USD 847
2018 - 2019
Project list item
Elucidating immunotherapy resistance mechanisms in non-T cell-inflamed bladder cancer

National Cancer Institute to RANDY F. SWEIS

USD 425,338
2018 - 2022
Project list item
DT-EGF Toxic Fusion Protein for the Treatment of Bladder Cancer

National Cancer Institute to MIKE GLODE, SHAWN PATRICK ZINNEN

USD 299,937
2018 - 2020
Project list item
Novel recombinant BCG for immunotherapy of bladder cancer

National Cancer Institute to BORIS SHOR

USD 290,014
2018 - 2020
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