A study of Chemo only versus Chemo plus Nivo with or without BMS986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS986205 in Patients with MIBC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Dec 2018 → 15 Apr 2026

Decision date (initial)

2024-06-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512158-12-00

EudraCT number

2017-004692-31

WHO UTN

U1111-1206-8521

ClinicalTrials.gov

NCT03661320

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Therapy, Efficacy, Pharmacodynamic, Pharmacogenomic

To compare the pCR rate of neoadjuvant nivolumab + GC to neoadjuvant GC alone in all randomized participants (Arm B vs. Arm A).

To compare EFS of neoadjuvant nivolumab + GC followed by continued nivolumab after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs. Arm A).

Secondary objectives 3

1. To compare overall survival (OS) of neoadjuvant nivolumab + GC followed by continued nivolumab therapy after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs Arm A).
2. To describe the safety and tolerability of nivolumab and nivolumab in combination with GC chemotherapy.
3. Secondary (Descriptive):To compare efficacy endpoints descriptively in all concurrently randomized patients (Arm C vs Arm B and Arm A).

Conditions and MedDRA coding

Bladder Cancer Muscle-Invasive Bladder Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component.
2. Participant must be deemed eligible for RC by his/her oncologist and/or urologist, and must agree to undergo RC after completion of neoadjuvant therapy.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria 3

1. Clinical evidence of positive LN (≥ 10 mm in short axis) or metastatic bladder cancer
2. Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted
3. Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone
2. Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo
3. Event-Free Survival (EFS) of SOC Chemo after RC
4. Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC

Secondary endpoints 5

1. Overall Survival (OS)
2. Incidence of Adverse Events (AE)
3. Incidence of Serious Adverse Events (SAE)
4. Incidence of Laboratory abnormalities
5. pCR rate, EFS, and OS as defined

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

mg-gsm-ct

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

mg-gsm-ct

Third parties 15

Locations

11 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 112 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications