Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol Myers Squibb International Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Jun 2017 → 8 Jan 2025

Decision date (initial)

2023-08-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2022-502909-15-00

EudraCT number

2016-001928-54

WHO UTN

U1111-1182-4341

ClinicalTrials.gov

NCT02985957

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

Evaluate objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 assessed by Blinded Independent Central Review (BICR) in subjects with mCRPC and measurable disease at baseline.
Assess Radiographic Progression Free Survival (rPFS) assessed by BICR in all treated subjects with mCRPC using RECIST V1.1 for soft tissue disease progression and PCWG2 for bone disease progression.

Secondary objectives 7

1. Assess radiographic/clinical Progression Free Survival (rcPFS)
2. Assess overall survival (OS)
3. Evaluate PSA response rate (PSA-RR)
4. Determine the safety and tolerability in all treated subjects
5. Estimate changes in pain as measured by the Brief Pain Inventory- Short Form (BPI-SF)
6. Estimate changes in cancer-related symptoms and quality of life (QoL) using the FACT-P questionnaire
7. Estimate changes in health status and health utility as measured by the 3-level EQ-5D-3L questionnaire

Conditions and MedDRA coding

Metastatic Castration-Resistant Prostate Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. ECOG performance status 0-1
2. Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
3. Ongoing androgen deprivation therapy (ADT) with a Gonadotropinreleasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)
4. For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

Exclusion criteria 6

1. Presence of visceral metastases in the liver
2. Active brain metastases or leptomeningeal metastases
3. Active, known, or suspected autoimmune disease or infection
4. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
5. For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab.
6. For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Objective Response Rate (ORR) in Cohort B, C, and Cohort D
2. Radiographic Progression-Free Survival (rPFS)

Secondary endpoints 14

1. Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C
2. Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D
3. Overall Survival (OS) in Cohort B, C
4. Overall Survival (OS) in Cohort D
5. Incidence of Adverse Events (AEs)
6. Incidence of Serious Adverse Events (SAEs)
7. Incidence of Adverse Events (AEs) leading to discontinuation
8. Incidence of Immune-mediated Adverse Events (IMAEs)
9. Incidence of deaths
10. Incidence of laboratory abnormalities: Hematology, Clinical Chemistry, Coagulation, Liver function, Thyroid function, Adrenal function, Renal function
11. Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF)
12. Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L)
13. Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire
14. Prostate Specfic Antigen (PSA) Response Rate

Investigational products

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

Test 6

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

Sponsor organisation

Bristol Myers Squibb International Corporation

Address

Terhulpsesteenweg 185

City

Watermaal-Bosvoorde

Postcode

1170

Country

Belgium

Scientific contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 14

Locations

1 EU/EEA country · 3 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 36 files

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

Application history

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