A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Conditions

Muscle-Invasive Bladder Cancer, Urinary Bladder Neoplasms

Brief summary

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Lara PN, Villanueva L, Ibanez C, Erman M, Lee JL, Heinrich D, Lipatov ON, Gedye C, Gokmen E, Acevedo A, Semenov A, Park SH, Gafanov RA, Kose F, Jones M, Du X, Munteanu M, Perini R, Choueiri TK, Motzer RJ.

2024-07-2514 citations

10.1186/s12885-023-10971-7

Pembrolizumab plus epacadostat in patients with recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE-669/ECHO-304): a phase 3, randomized, open-label study.

Cho BC, Braña I, Cirauqui B, Aksoy S, Couture F, Hong RL, Miller WH, Chaves-Conde M, Teixeira M, Leopold L, Munteanu M, Ge JY, Swaby RF, Hughes BGM.

2024-07-259 citations

10.1186/s12885-023-11316-0

Pembrolizumab plus either epacadostat or placebo for cisplatin-ineligible urothelial carcinoma: results from the ECHO-307/KEYNOTE-672 study.

Necchi A, Van der Heijden MS, Trukhin D, Peer A, Gurney H, Alekseev BY, Parnis FX, Leibowitz R, De Santis M, Grivas P, Clark J, Munteanu M, Kataria R, Jia C, Balar AV, de Wit R.

2024-07-255 citations

10.1186/s12885-023-10727-3

PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy.

Grivas P, Koshkin VS, Chu X, Cole S, Jain RK, Dreicer R, Cetnar JP, Sundi D, Gartrell BA, Galsky MD, Woo B, Li-Ning-Tapia E, Hahn NM, Carducci MA.

2023-12-2722 citations

10.1016/j.euo.2023.11.022

Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial

Matthew D. Galsky, Siamak Daneshmand, Sudeh Izadmehr, Edgar Gonzalez‐Kozlova, Kevin Chan et al. (40 authors)

Nature Medicine2023-10-02109 citations

10.1038/s41591-023-02568-1

PrE0807: A phase Ib feasibility trial of neoadjuvant nivolumab (N) without or with lirilumab (L) in cisplatin-ineligible patients (pts) with muscle-invasive bladder cancer (MIBC).

Petros Grivas, Jun Yin, Vadim S. Koshkin, Suzanne Cole, Rohit Jain et al. (13 authors)

Journal of Clinical Oncology2021-05-2017 citations

10.1200/jco.2021.39.15_suppl.4518

A phase III randomized study of neoadjuvant chemotherapy (NAC) alone or in combination with nivolumab (NIVO) ± linrodostat mesylate, followed by adjuvant postsurgical NIVO ± linrodostat, in cisplatin-eligible muscle invasive bladder cancer (MIBC).

Guru Sonpavde, Andrea Necchi, Shilpa Gupta, Gary D. Steinberg, Juergen E. Gschwend et al. (12 authors)

Journal of Clinical Oncology2020-05-202 citations

10.1200/jco.2020.38.15_suppl.tps5091

Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial.

Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E.

2020-03-05359 citations

10.1016/s0140-6736(20)30415-3

ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer

Guru Sonpavde, Andrea Necchi, Shilpa Gupta, Gary D. Steinberg, Juergen E. Gschwend et al. (12 authors)

Future Oncology2019-12-1190 citations

10.2217/fon-2019-0611

A phase 3 randomized study of neoadjuvant chemotherapy (NAC) alone or in combination with nivolumab (NIVO) ± BMS-986205 in cisplatin-eligible muscle invasive bladder cancer (MIBC).

Guru Sonpavde, Andrea Necchi, Shilpa Gupta, Gary D. Steinberg, Juergen E. Gschwend et al. (12 authors)

Journal of Clinical Oncology2019-05-209 citations

10.1200/jco.2019.37.15_suppl.tps4587

Interventions

BIOLOGICALNivolumab

Specified dose on specified days

DRUGGemcitabine

Specified dose on specified days

DRUGCisplatin

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria

* Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer * Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Design outcomes

Primary

Measure	Time frame	Description
Pathological Complete Response (pCR) rate, in all randomized participants	Approximately 43 months	Arm B vs. Arm A
Event-Free Survival (EFS), in all randomized participants	Approximately 36 months	Arm B vs. Arm A

Secondary

Measure	Time frame	Description
Overall Survival (OS) in all randomized participants	Approximately 60 months	Arm B vs. Arm A
Incidence of Adverse Events (AE) in participants who received at least one treatment dose	Approximately 60 months	—
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose	Approximately 60 months	—
Incidence of deaths in participants who received at least one treatment dose	Approximately 60 months	—
Incidence of laboratory abnormalities in participants who received at least one treatment dose	Approximately 60 months	—
pCR rate, descriptively in all concurrently randomized participants	Approximately 43 months	Arm C vs. Arm B and Arm A
EFS, descriptively in all concurrently randomized participants	Approximately 36 months	Arm C vs. Arm B and Arm A
OS, descriptively in all concurrently randomized participants	Approximately 60 months	Arm C vs. Arm B and Arm A

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Finland, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Conditions

Brief summary

Related papers

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Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

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Outcome results