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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05328908




Registration number
NCT05328908
Ethics application status
Date submitted
14/03/2022
Date registered
14/04/2022
Date last updated
1/03/2024

Titles & IDs
Public title
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
Scientific title
A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer
Secondary ID [1] 0 0
2021-004285-35
Secondary ID [2] 0 0
CA224-123
Universal Trial Number (UTN)
Trial acronym
RELATIVITY-123
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab-relatlimab FDC
Treatment: Drugs - Regorafenib
Treatment: Drugs - TAS-102

Experimental: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC) -

Active Comparator: Arm B: Investigator's Choice - Treatment with Regorafenib or TAS-102


Treatment: Drugs: Nivolumab-relatlimab FDC
Specified dose on specified days

Treatment: Drugs: Regorafenib
Specified dose on specified days

Treatment: Drugs: TAS-102
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) = 1
Timepoint [1] 0 0
Up to 5 years after last participant randomized
Primary outcome [2] 0 0
OS in all randomized participants
Timepoint [2] 0 0
Up to 5 years after last participant randomized
Secondary outcome [1] 0 0
Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in randomized participants with PD-L1 CPS = 1
Timepoint [1] 0 0
Up to 5 years after last participant randomized
Secondary outcome [2] 0 0
ORR by BICR per RECIST v1.1 in all randomized participants
Timepoint [2] 0 0
Up to 5 years after last participant randomized
Secondary outcome [3] 0 0
Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS = 1
Timepoint [3] 0 0
Up to 5 years after last participant randomized
Secondary outcome [4] 0 0
PFS by BICR per RECIST v1.1 in all randomized participants
Timepoint [4] 0 0
Up to 5 years after last participant randomized
Secondary outcome [5] 0 0
Duration of response (DoR) by BICR per RECIST v1.1 in responders with PD-L1 CPS = 1
Timepoint [5] 0 0
Up to 5 years after last participant randomized
Secondary outcome [6] 0 0
DoR by BICR per RECIST v1.1 in all responders
Timepoint [6] 0 0
Up to 5 years after last participant randomized
Secondary outcome [7] 0 0
Number of participants with adverse events (AEs)
Timepoint [7] 0 0
Up to 135 days after participant's last dose
Secondary outcome [8] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [8] 0 0
Up to 135 days after participant's last dose
Secondary outcome [9] 0 0
Number of participants with immune-mediated adverse events (IMAEs)
Timepoint [9] 0 0
Up to 135 days after participant's last dose
Secondary outcome [10] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [10] 0 0
Up to 135 day's after participant's last dose
Secondary outcome [11] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [11] 0 0
Up to 135 days after participant's last dose
Secondary outcome [12] 0 0
Time Until Definitive Deterioration-Physical Function (TUDD-PF): The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS = 1
Timepoint [12] 0 0
Up to follow up visit 2 (approximately 135 days after last dose)
Secondary outcome [13] 0 0
TUDD-PF: The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in all randomized participants
Timepoint [13] 0 0
Up to follow up visit 2 (approximately 135 days after last dose)
Secondary outcome [14] 0 0
TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in randomized participants with PD-L1 CPS = 1
Timepoint [14] 0 0
Up to follow up visit 2 (approximately 135 days after last dose)
Secondary outcome [15] 0 0
TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in all randomized participants
Timepoint [15] 0 0
Up to follow up visit 2 (approximately 135 days after last dose)
Secondary outcome [16] 0 0
PFS by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS = 1
Timepoint [16] 0 0
Up to 5 years after last participant randomized
Secondary outcome [17] 0 0
PFS by investigator per RECIST v1.1 in all randomized participants
Timepoint [17] 0 0
Up to 5 years after last participant randomized
Secondary outcome [18] 0 0
ORR by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS = 1
Timepoint [18] 0 0
Up to 5 years after last participant randomized
Secondary outcome [19] 0 0
ORR by investigator per RECIST v1.1 in all randomized participants
Timepoint [19] 0 0
Up to 5 years after last participant randomized
Secondary outcome [20] 0 0
DoR by investigator per RECIST v1.1 in responders with PD-L1 CPS = 1
Timepoint [20] 0 0
Up to 5 years after last participant randomized
Secondary outcome [21] 0 0
DoR by investigator per RECIST v1.1 in all randomized participants
Timepoint [21] 0 0
Up to 5 years after last participant randomized

Eligibility
Key inclusion criteria
Inclusion Criteria

- Histological confirmed previously treated colorectal cancer with adenocarcinoma
histology with metastatic or recurrent unresectable disease at study entry.

- Participants must have:.

i) progressed during or within approximately 3 months following the last
administration of approved standard therapies (at least 1, but not more than 4 prior
lines of therapies in the metastatic setting), which must include a fluoropyrimidine,
oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS
wild-type), if available in the respective country, or;.

ii) been intolerant to prior systemic chemotherapy regimens if there is documented evidence
of clinically significant intolerance despite adequate supportive measures.

- Must have sufficient tumor tissue & evaluable PD-L1 expression to meet the study
requirements.

- Must have measurable disease per RECIST v1.1. Participants with lesions in a
previously irradiated field as the sole site of measurable disease will be permitted
to enroll provided the lesion(s) have demonstrated clear progression and can be
measured accurately.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Prior treatment with either an immunotherapy or with regorafenib or with TAS-102.

- Untreated central nervous system (CNS) metastases, participants are eligible if CNS
metastases have been treated and participants have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment).

- History of refractory hypertension not controlled with anti-hypertensive therapy,
myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary
syndrome within 6 months prior to dosing, Class II congestive heart failure (as per
the New York Heart Association Functional Classification), interstitial lung
disease/pneumonitis or an active, known or suspected autoimmune disease.

- Confirmed tumor microsatellite instable high/deficient mismatch repair (MSI-H/dMMR)
status as per local standard testing; MSI/MMR test results from initial diagnosis are
acceptable.

- Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2028
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0098 - Wagga Wagga
Recruitment hospital [2] 0 0
Local Institution - 0114 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0001 - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - 0010 - Clayton
Recruitment hospital [5] 0 0
Local Institution - 0021 - Melbourne
Recruitment hospital [6] 0 0
Local Institution - 0027 - Murdoch
Recruitment postcode(s) [1] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Connecticut
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Idaho
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Indiana
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Buenos Aires
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B
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Argentina
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Ciudad Autónoma Buenos Aires
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Rio Grande
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Graz
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Klagenfurt Am Woerthersee
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Goyang-si, Gyeonggi-do
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Seongnamsi Bundanggu
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MZ
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Pl-mz
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Kraków
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Warszawa
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San Juan
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Bern
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KHH
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TNN
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TPE
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Taiwan
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Tainan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate relatlimab in combination with nivolumab,
administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as
BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient
mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1
but no more than 4 prior lines of therapy for metastatic disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05328908
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries