A Study of Nivolumab and Nivolumab Combinations in Recurrent and Metastatic Colon 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 and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 May 2014 → 23 Oct 2024

Decision date (initial)

2024-10-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2024-516004-42-01

EudraCT number

2013-003939-30

ClinicalTrials.gov

NCT02060188

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

The purpose of this study is to examine if Nivolumab alone, Nivolumab in combination with Ipilimumab, Nivolumab in combination with anti-LAG3 agent (BMS-986016), or Nivolumab in combination with daratumumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.

Secondary objectives 3

1. To evaluate the IRRC-assessed objective response rate (ORR) of nivolumab monotherapy and nivolumab in combination with either ipilimumab or anti-LAG-3 antibody (BMS-986016) in dMMR/MSI-H mCRC;
2. the ORR of nivolumab combined with ipilimumab in subjects with metastatic non-MSI-H (pMMR) CRC;
3. the IRRC-ORR of nivolumab combined with daratumumab therapy in subjects with metastatic non- MSI-H (pMMR) mCRC.

Conditions and MedDRA coding

MSI Negative Colorectal Cancer

Regulatory references

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb’s data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. •Men and women ≥ 18 years of age
2. •ECOG performance status 0 to 1.
3. •Histologically confirmed colorectal cancer.
4. •Measurable disease by CT or MRI.
5. •Testing for MSI Status a. Subjects with microsatellite instability high (MSI-H) tumors will enroll in the MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort. b. Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H) will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.
6. •Adequate organ function as defined by study-specific laboratory tests
7. •Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP.
8. •Signed informed consent
9. •Willing and able to comply with study procedures -Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion criteria 5

1. •Active brain metastases or leptomeningeal metastases are not allowed.
2. •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co- stimulation or immune checkpoint pathways.
3. •Prior malignancy active within the previous 3 years except for locally curable cancers
4. •Subjects with active, known or suspected autoimmune disease.
5. •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators

Secondary endpoints 1

1. ORR in all MSI-H and non-MSI-H subjects based on IRRC

Investigational products

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

Test 6

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 Representative

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT Representative

Third parties 7

Locations

2 EU/EEA countries · 4 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 29 files

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

Application history

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