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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06750094




Registration number
NCT06750094
Ethics application status
Date submitted
20/12/2024
Date registered
27/12/2024
Date last updated
27/12/2024

Titles & IDs
Public title
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
Scientific title
A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
Secondary ID [1] 0 0
61186372COR3002
Secondary ID [2] 0 0
61186372COR3002
Universal Trial Number (UTN)
Trial acronym
OrigAMI-3
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: Other - Amivantamab
Treatment: Other - Cetuximab
Treatment: Other - Bevacizumab
Treatment: Drugs - 5-fluorouracil
Treatment: Drugs - Leucovorin calcium/Levoleucovorin
Treatment: Drugs - Irinotecan

Experimental: Arm A: Amivantamab + FOLFIRI - Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium \[folinic acid\] or levoleucovorin, and irinotecan) as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

Active comparator: Arm B: Cetuximab or Bevacizumab + FOLFIRI - Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.


Treatment: Other: Amivantamab
Amivantamab will be administered.

Treatment: Other: Cetuximab
Cetuximab will be administered.

Treatment: Other: Bevacizumab
Bevacizumab will be administered.

Treatment: Drugs: 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.

Treatment: Drugs: Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

Treatment: Drugs: Irinotecan
Irinotecan will be administered as chemotherapy regimen.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to 2 years 1 month
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 4 years 4 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by BICR
Timepoint [1] 0 0
Up to 4 years 4 months
Secondary outcome [2] 0 0
Progression Free Survival as Assessed by Investigator
Timepoint [2] 0 0
Up to 4 years 4 months
Secondary outcome [3] 0 0
Objective Response Rate as Assessed by Investigator
Timepoint [3] 0 0
Up to 4 years 4 months
Secondary outcome [4] 0 0
Duration of Response (DoR) as Assessed by BICR
Timepoint [4] 0 0
Up to 4 years 4 months
Secondary outcome [5] 0 0
Duration of Response as Assessed by Investigator
Timepoint [5] 0 0
Up to 4 years 4 months
Secondary outcome [6] 0 0
Progression Free Survival After Subsequent Therapy (PFS2)
Timepoint [6] 0 0
Up to 4 years 4 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR) as Assessed by BICR
Timepoint [7] 0 0
Up to 4 years 4 months
Secondary outcome [8] 0 0
Disease Control Rate as Assessed by Investigator
Timepoint [8] 0 0
Up to 4 years 4 months
Secondary outcome [9] 0 0
Time to Treatment Failure
Timepoint [9] 0 0
Up to 4 years 4 months
Secondary outcome [10] 0 0
Curative Resection (R0) Rate
Timepoint [10] 0 0
Up to 4 years 4 months
Secondary outcome [11] 0 0
Number of Participants with Adverse Events (AEs) by Severity
Timepoint [11] 0 0
Up to 4 years 4 months
Secondary outcome [12] 0 0
Number of Participants with Abnormalities in Laboratory Values
Timepoint [12] 0 0
Up to 4 years 4 months
Secondary outcome [13] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Timepoint [13] 0 0
From baseline up to 4 years 4 months
Secondary outcome [14] 0 0
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Timepoint [14] 0 0
Up to 4 years 4 months
Secondary outcome [15] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C29) Score
Timepoint [15] 0 0
From baseline up to 4 years 4 months
Secondary outcome [16] 0 0
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C29 Score
Timepoint [16] 0 0
Up to 4 years 4 months
Secondary outcome [17] 0 0
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Timepoint [17] 0 0
Up to 4 years 4 months

Eligibility
Key inclusion criteria
* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
* Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local testing
* Must agree to the submission of fresh or archival tumor tissue post-progression from the most recent therapy, if clinically feasible
* Have measurable disease according to RECIST v1.1
* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
* Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
* Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
* Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/04/2029
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital - South Woodville
Recruitment hospital [4] 0 0
Western Health Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
5011 - South Woodville
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
Malaysia
State/province [3] 0 0
Kuala Lumpur
Country [4] 0 0
Malaysia
State/province [4] 0 0
Kuching
Country [5] 0 0
Puerto Rico
State/province [5] 0 0
Barrio Monacillos
Country [6] 0 0
Taiwan
State/province [6] 0 0
Kaohsiung
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT06750094
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06750094