CheckMate 032:CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 032

2024-516540-25-00 Protocol CA209-032 Phase I and Phase II (Integrated) - Other Ended

Start 11 Dec 2013 · End 19 Nov 2024 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol CA209-032

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ended
Participants planned 1,703
Countries 1
Sites 2

Advanced or metastatic solid tumors: 1) Triple Negative Breast Cancer (TNBC) 2) Gastric Cancer (GC) 3) Pancreatic Cancer (PC) 4) Small Cell Lung Cancer (SCLC). 5) Bladder Cancer (BC) 6) Ovarian Cancer (OC)

To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC), Bladder Cancer (BC) and Ovarian Cancer (OC).

Key facts

Sponsor
Bristol Myers Squibb International Corporation
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
11 Dec 2013 → 19 Nov 2024
Decision date (initial)
2024-09-12
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
No

External identifiers

EU CT number
2024-516540-25-00
EudraCT number
2013-002844-10
ClinicalTrials.gov
NCT01928394

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To investigate the safety and efficacy of Nivolumab as a single agent or
in combination with Ipilimumab in 6 tumor types - triple-negative breast
cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC),
and small cell lung cancer (SCLC), Bladder Cancer (BC) and Ovarian
Cancer (OC).

Secondary objectives 5

  1. BOR (Best Overall Response)
  2. DOR (Duration of Response)
  3. Safety
  4. PFS (Performance Free Survival)
  5. OS (Overall Survival)

Conditions and MedDRA coding

Advanced or metastatic solid tumors: 1) Triple Negative Breast Cancer (TNBC) 2) Gastric Cancer (GC) 3) Pancreatic Cancer (PC) 4) Small Cell Lung Cancer (SCLC). 5) Bladder Cancer (BC) 6) Ovarian Cancer (OC)

VersionLevelCodeTermSystem organ class
20.0 PT 10006187 Breast cancer 100000004864
21.0 LLT 10033604 Pancreatic cancer 10029104
20.0 PT 10033128 Ovarian cancer 100000004864
21.1 PT 10017758 Gastric cancer 100000004864
21.1 PT 10041067 Small cell lung cancer 100000004864
20.0 PT 10005003 Bladder cancer 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types: Triple Negative Breast Cancer
  2. Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Gastric Cancer
  3. Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Pancreatic Cancer
  4. Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Small Cell Lung Cancer
  5. Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Ovarian Carcinoma
  6. Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:Bladder Cancer
  7. Subjects must have measurable disease
  8. ECOG of 0 or 1.

Exclusion criteria 4

  1. Active brain metastases or leptomeningeal metastases
  2. Subjects with active, known or suspected autoimmune disease
  3. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
  4. Prior therapy with experimental anti-tumor vaccines; any T cell costimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti- PD-L2, anti-CD137, or anti-CTLA-4 antibody, including ipilimumab; or other medicines specifically targeting T cell is also prohibited

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Objective response rate (ORR) in all assigned subjects as determined by the investigators. ORR is defined as the number of subjects with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects

Secondary endpoints 3

  1. Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment
  2. Progression Free Survival (PFS)
  3. Overall Survival (OS)

Investigational products

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

Test 3

OPDIVO 10 mg/mL concentrate for solution for infusion.

PRD2941375 · Product

Active substance
Nivolumab
Substance synonyms
BMS936558, ABP 206
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Authorisation status
Authorised
ATC code
L01FF01 — -
Marketing authorisation
EU/1/15/1014/002
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ipilimumab

PRD191357 · Product

Active substance
Ipilimumab
Other product name
MDX-010
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Authorisation status
Not Authorised
MA holder
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation
No
Orphan designation
No

Ipilimumab

PRD191358 · Product

Active substance
Ipilimumab
Other product name
MDX-010
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Authorisation status
Not Authorised
MA holder
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

26 Total trials 26 Ended
Commercial
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 19

OrganisationCity, countryDuties
Myriad RBM Inc.
ORG-100045698
 Austin, United States Other
Nordic Bioscience A/S
ORG-100009315
 Herlev, Denmark Other
Foundation Medicine Inc.
ORG-100040457
 Cambridge, United States Other
Accenture Solutions Private Limited
ORG-100032592
 Chennai, India Data management
Neogenomics Laboratories Inc.
ORG-100041804
 Aliso Viejo, United States Other
Accenture Services Pvt. Ltd.
ORL-000000127
 Bengaluru, India Other
Cellcarta Naperville LLC
ORG-100042145
 Naperville, United States Other
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Other
Q2 Solutions
ORL-000000243
 West Lothian, United Kingdom Other
Htg Molecular Diagnostics Inc.
ORG-100046509
 Tucson, United States Other
Myriad Genetics Inc.
ORG-100046746
 Salt Lake City, United States Other
Azenta Germany GmbH
ORG-100022621
 Griesheim, Germany Other
Parexel International Corporation
ORL-000006899
 Billerica, MA, United States Other
Labcorp | Center for Molecular Biology and Pathology
ORL-000005147
 Durham, United States Other
Memorial Sloan Kettering Cancer Center
ORG-100029687
 New York, United States Other
PPD Development LP
ORG-100011560
 Richmond, United States Other
Mosaic Laboratories LLC
ORG-100042385
 Lake Forest, United States Other
Accenture Services Pvt. Ltd.
ORL-000000126
 Bengaluru, India Other, Data management
Icon Laboratory Services Inc.
ORG-100037135
 Farmingdale, United States Other

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 83 2
Rest of world
United States, United Kingdom
 — 1,620 —

Investigational sites

Germany

2 sites · Ended
Universitaetsklinikum Bonn AöR
Haemato- Onkologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Heidelberg AöR
Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2013-12-11 2024-11-18 2014-01-08 2017-09-01

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

TitleSubmission dateStatusType
2024-516540-25-00_Final results
SUM-106936
 2025-11-18T15:31:57 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
2024-516540-25-00_plain langauge summary 2025-11-18T15:33:21 Submitted Laypersons Summary of Results
2024-516540-25-00_plain language summary_German 2025-12-10T16:39:35 Submitted Laypersons Summary of Results

Documents 27 files

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

TypeTitleVersion
Laypersons summary of results (for publication) 2024-516540-25-00_plain langauge summary N/A
Laypersons summary of results (for publication) 2024-516540-25-00_plain language summary_German 1
Protocol (for publication) D1_Protocol 2024-516540-25-00_Redacted 10
Protocol (for publication) D1_Protocol Administrative Letter_Redacted 8
Recruitment arrangements (for publication) K1_Recruitment and Informed Consent Procedures Form_blank statement_DE 1
Subject information and informed consent form (for publication) L1_ICF Addendum V02_DE_unredacted 02
Subject information and informed consent form (for publication) L1_ICF Addendum V03_DE_unredacted 03
Subject information and informed consent form (for publication) L1_ICF Addendum V04_DE_unredacted 04
Subject information and informed consent form (for publication) L1_ICF Addendum V05_DE_unredacted 05
Subject information and informed consent form (for publication) L1_ICF Addendum V06_DE_unredacted 06
Subject information and informed consent form (for publication) L1_ICF Addendum V07_DE_unredacted 07
Subject information and informed consent form (for publication) L1_ICF Addendum V08_DE_unredacted 08
Subject information and informed consent form (for publication) L1_ICF Addendum V09_DE_unredacted 09
Subject information and informed consent form (for publication) L1_ICF Addendum V10_DE_unredacted 10
Subject information and informed consent form (for publication) L1_ICF Addendum V11_DE_unredacted 11
Subject information and informed consent form (for publication) L1_ICF Addendum V12_DE_unredacted 12
Subject information and informed consent form (for publication) L1_ICF Addendum V13_DE_unredacted 13
Subject information and informed consent form (for publication) L1_ICF Addendum V14_DE_unredacted 14
Subject information and informed consent form (for publication) L1_ICF Addendum V15_DE_unredacted 1
Subject information and informed consent form (for publication) L1_ICF beyond Progression_DE_unredacted 1
Subject information and informed consent form (for publication) L1_ICF Main_TC_DE_unredacted 13
Summary of results (for publication) 2024-516540-25-00_Final results PART I N/A
Summary of results (for publication) 2024-516540-25-00_Final results PART II N/A
Summary of results (for publication) 2024-516540-25-00_Final results PART III N/A
Summary of results (for publication) 2024-516540-25-00_Final results PART IV N/A
Summary of results (for publication) 2024-516540-25-00_Final results PART V N/A
Synopsis of the protocol (for publication) D1_Protocol Synopsis_EN_2024-516540-25-00 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-29 Germany Acceptable
2024-09-12
 2024-09-12
2 SUBSTANTIAL MODIFICATION SM-1 2024-11-07 Germany Acceptable
2024-11-20
 2024-11-22

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