Abstract 2944
Background
The addition of docetaxel (Dx) to androgen deprivation therapy (ADT), as first-line in patients (pt) with high-volume metastatic hormone-sensitive prostate cancer (hvHSPC) has demonstrated to increase time to biochemical, radiographic and clinical progression (bPFS, rPFS, cPFS), as well as overall survival (OS) in two different trials. We hypothesized that early addition of immunotherapy (I/O) or other new drugs to ADT+Dx could improve outcomes. A MAMS has been designed to optimize resources and recruitment, by concurrently comparing different new strategies, and selecting the most effective(s) for a final phase III trial.
Trial design
PROSTRATEGY is a randomized MAMS trial in pt with hvHSPC, comparing ADT+Dx (control arm: ADT + 6 cycles of Dx 75 mg/m2 + GCSF), to ADT+DX+Nivo (ADT+Dx followed by Nivolumab 3 mg/Kg/2w x 12 mo), or ADT+Ipi+Dx+Nivo (ADT + 2 cycles of Ipilimumab 3 mg/Kg/3w, followed by 3 cycles of Dx + GCSF, 2 cycles of Ipilimumab, 3 cycles of Dx + GCSF, and then Nivolumab 3 mg/Kg/2w x 12 mo). Randomization rate (ADT+Dx/experimental arms) is 2/1. The design allows that additional experimental arms with ADT+DX + other potential active drugs could also be incorporated in the future to the study. According to a priori established criteria based on cPFS, those arms considered not sufficiently effective at any of the 3 planned intermediate stages, will be closed. Those arms that meet the intermediate endpoints will remain in the study, and will be compared to ADT-DX in a seamless phase III trial, with OS (HR = 0.75) as a primary end-point. The pilot phase with the first 120 pt of the first stage of the trial has been started in 30 centres in Spain funded by Bristol-Myers Squibb. The aim is to assess safety of I/O arms, and to estimate and compare outcomes based on RECIST, iRECIST and PCWG3 criteria of efficacy. Collaboration with other cooperative groups is also planned after the pilot phase.
Clinical trial identification
2017-004377-13.
Editorial acknowledgement
Legal entity responsible for the study
SOGUG: Spanish Oncology Genito-Urinary Group.
Funding
Bristol-Myers Squibb.
Disclosure
J.A. Arranz Arija: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: Astellas-Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Bayer; Advisory / Consultancy: Ipsen; Research grant / Funding (institution): Pierre-Fabre. B. P. Valderrama: Honoraria (self), Advisory / Consultancy: Pierre-Fabre; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Bayer; Advisory / Consultancy: Sanofi-Aventis; Advisory / Consultancy: MSD Oncology; Travel / Accommodation / Expenses: Janssen-Cilag; Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: EUSA Pharma. T. Alonso Gordoa: Advisory / Consultancy: Bristol-Myers-Squibb; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy, Research grant / Funding (self): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi-Aventis; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony: Janssen-Cilag; Speaker Bureau / Expert testimony: Novartis. E. Gallardo Diaz: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Rovi; Honoraria (self), Advisory / Consultancy: Daiichi; Honoraria (self), Advisory / Consultancy: Sankyo; Advisory / Consultancy: Techdow; Honoraria (self): Leo Pharma; Honoraria (self): Menarini; Travel / Accommodation / Expenses: Pierre-Fabre; Travel / Accommodation / Expenses: Ferrer; Travel / Accommodation / Expenses: GSK. J.M. Sepulveda Sanchez: Advisory / Consultancy, Travel / Accommodation / Expenses: AbbVie; Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Catalysis; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas Pharma; Travel / Accommodation / Expenses: Ipsen. J.M. Piulats: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Research grant / Funding (self): MSD Oncology; Advisory / Consultancy, Research grant / Funding (self): Merck-Serono; Advisory / Consultancy: Novartis; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Janssen-Cilag; Advisory / Consultancy: Clovis; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas Pharma; Advisory / Consultancy: Roche; Advisory / Consultancy: BeiGene; Advisory / Consultancy: VCN Bioscience; Travel / Accommodation / Expenses: Ipsen; Research grant / Funding (institution): Pfizer; Research grant / Funding (self): Incyte. M.J. Mendez Vidal: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Bayer Healthcare; Honoraria (self), Advisory / Consultancy: Sanofi-Aventis; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer. N. Sala González: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Sanofi. S. Vazquez Estevez: Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Astellas Pharma; Advisory / Consultancy: Janssen-Cilag; Advisory / Consultancy: MSD Oncology; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy: Eisai; Honoraria (institution), Advisory / Consultancy: Sanofi-Aventis; Honoraria (self): Lilly. M. Lázaro Quintela: Advisory / Consultancy: Bristol-Myers-Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre-Fabre; Advisory / Consultancy: Bayer; Honoraria (self): Lilly; Honoraria (self), Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self): Novartis; Honoraria (self): Vifor. M.A. Climent Duran: Honoraria (self), Advisory / Consultancy: Bristol-Myers-Squibb; Honoraria (self), Travel / Accommodation / Expenses: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen-Cilag; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self): Sanofi-Aventis; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy: Pierre-Fabre. J. Puente: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi-Aventis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Janssen-Cilag; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen; Advisory / Consultancy: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy: EUSA Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD Oncology; Travel / Accommodation / Expenses: Pierre-Fabre. J. García Sánchez: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy: EUSA Pharma; Travel / Accommodation / Expenses: Bristol-Myers-Squibb; Travel / Accommodation / Expenses: MSD Oncology; Travel / Accommodation / Expenses: Pfizer. J. Carles: Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Aragon Pharmaceuticals; Research grant / Funding (institution): Arog Pharmaceuticals, Inc.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas Pharma; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca AB; Research grant / Funding (institution): Aveo Pharmaceuticals, Inc.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bayer AG; Research grant / Funding (institution): Blueprint Medicines Corporation; Research grant / Funding (institution): BN Immunotherapeuticals, Inc.; Research grant / Funding (institution): Boehringer Ingelheim España SA; Research grant / Funding (institution): Bristol-Myers-Squibb International Corporation; Research grant / Funding (institution): Clovis Oncology, Inc.; Research grant / Funding (institution): Cougar Biotechnology, Inc.; Research grant / Funding (institution): Deciphera Pharmaceuticals LLC; Research grant / Funding (institution): Exerelixis Inc.; Research grant / Funding (institution): F. Hoffmann-La Roche Ltd.; Research grant / Funding (institution): Genentech, INC; Research grant / Funding (institution): GlaxoSmithKline SA; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Janssen-Cilag International NV; Research grant / Funding (institution): Karyopharm Therapeutics Inc.; Research grant / Funding (institution): Laboratoires Leurquin Mediolanum SAS; Research grant / Funding (institution): Lilly SA; Research grant / Funding (institution): Medimmune; Travel / Accommodation / Expenses: Millennium Pharmaceuticals Inc.; Research grant / Funding (institution): Nanobiotix S.A.; Research grant / Funding (institution): Novartis Pharmaceutical SA; Research grant / Funding (institution): Pfizer SLU; Research grant / Funding (self): Puma Biotechnology, Inc.; Advisory / Consultancy, Research grant / Funding (institution): Sanofi-Aventis S.A.; Speaker Bureau / Expert testimony: SFJ Pharma Ltd.II; Research grant / Funding (institution): Teva Pharma SLU; Advisory / Consultancy: Bristol-Myers-Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Johnson and Johnson; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony: Asofarma. All other authors have declared no conflicts of interest.
Resources from the same session
2262 - Real world experience of Nivolumab therapy in Metastatic Renal Cancer patients: a 3 year multi-centre review
Presenter: Joanna Hack
Session: Poster Display session 3
Resources:
Abstract
4441 - “A pilot study of tremelimumab (treme) with or without cryoablation (cryo) in patients (pts) in metastatic renal cell carcinoma (mRCC).”
Presenter: Matthew Campbell
Session: Poster Display session 3
Resources:
Abstract
2613 - Lenvatinib (Len) alone or in combination with Everolimus (Eve) in heavily pretreated patients (pts) with metastatic renal cell carcinoma (mRCC) after immune checkpoint inhibitors (ICI) and VEGFR-targeted therapies: A single-institution experience
Presenter: Andrew Wiele
Session: Poster Display session 3
Resources:
Abstract
3249 - Weight loss is an underestimated adverse event with cabozantinib in patients with metastastic renal cell carcinoma (mRCC).
Presenter: Emeline Colomba
Session: Poster Display session 3
Resources:
Abstract
2405 - Impact of corticosteroids on nivolumab activity in metastatic clear cell renal cell carcinoma.
Presenter: Felix Lefort
Session: Poster Display session 3
Resources:
Abstract
4020 - Skeletal muscle loss as an adverse event during Cabozantinib treatment in patients with metastatic renal cell carcinoma
Presenter: Carolina Alves Costa Silva
Session: Poster Display session 3
Resources:
Abstract
2407 - Long term relative survival (RS) in patients with primary metastatic kidney cancer (primary mRCC): an analysis of 2,167 patients from the Austrian National Cancer Registry (ANCR).
Presenter: Monika Hackl
Session: Poster Display session 3
Resources:
Abstract
2470 - Advanced renal cell carcinoma: first results from the prospective research platform CARAT for patients with mRCC in Germany
Presenter: Peter Goebell
Session: Poster Display session 3
Resources:
Abstract
1533 - Are immune checkpoint inhibitors a valid option for papillary Renal Cell Carcinoma? Transcriptomic characterization of the immune infiltrate
Presenter: Manon De Vries-brilland
Session: Poster Display session 3
Resources:
Abstract
3367 - Treatment-Free Survival, With and Without Toxicity, as a Novel Outcome Applied to Immuno-Oncology Agents in Advanced Renal Cell Carcinoma
Presenter: Meredith Regan
Session: Poster Display session 3
Resources:
Abstract