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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

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)
Assessment method [1] 0 0
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.
Timepoint [1] 0 0
Up to 2 years 1 month
Primary outcome [2] 0 0
Overall Survival (OS)
Assessment method [2] 0 0
OS is defined as the time from the date of randomization to the date of participant's death due to any cause.
Timepoint [2] 0 0
Up to 4 years 4 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by BICR
Assessment method [1] 0 0
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria.
Timepoint [1] 0 0
Up to 4 years 4 months
Secondary outcome [2] 0 0
Progression Free Survival as Assessed by Investigator
Assessment method [2] 0 0
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, 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
Assessment method [3] 0 0
ORR is defined as the percentage of randomized participants achieving PR or CR, 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
Assessment method [4] 0 0
DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR 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
Assessment method [5] 0 0
DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR 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)
Assessment method [6] 0 0
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent systemic anticancer therapy, based on investigator assessment or death, whichever comes first.
Timepoint [6] 0 0
Up to 4 years 4 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR) as Assessed by BICR
Assessment method [7] 0 0
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as defined by BICR using RECIST v1.1.
Timepoint [7] 0 0
Up to 4 years 4 months
Secondary outcome [8] 0 0
Disease Control Rate as Assessed by Investigator
Assessment method [8] 0 0
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as assessed by investigator.
Timepoint [8] 0 0
Up to 4 years 4 months
Secondary outcome [9] 0 0
Time to Treatment Failure
Assessment method [9] 0 0
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy.
Timepoint [9] 0 0
Up to 4 years 4 months
Secondary outcome [10] 0 0
Curative Resection (R0) Rate
Assessment method [10] 0 0
Curative resection (R0) rate is defined as the percentage of randomized participants who underwent curative surgery.
Timepoint [10] 0 0
Up to 4 years 4 months
Secondary outcome [11] 0 0
Number of Participants with Adverse Events (AEs) by Severity
Assessment method [11] 0 0
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Timepoint [11] 0 0
Up to 4 years 4 months
Secondary outcome [12] 0 0
Number of Participants with Abnormalities in Laboratory Values
Assessment method [12] 0 0
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
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
Assessment method [13] 0 0
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
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
Assessment method [14] 0 0
Time to worsening in symptoms and functioning as measured by EORTC QLQ-C30 score will be reported. The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
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
Assessment method [15] 0 0
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.
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
Assessment method [16] 0 0
Time to worsening in symptoms and functioning as measured by EORTC QLQ-CR29 will be reported. EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. Change from baseline in the EORTC QLQ-CR29 score will be reported.
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
Assessment method [17] 0 0
EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much. Higher scores indicates severe symptoms.
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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Belgium
State/province [17] 0 0
Anderlecht
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Belgium
State/province [20] 0 0
Haine Saint Paul La Louviere
Country [21] 0 0
Belgium
State/province [21] 0 0
Kortrijk
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Brazil
State/province [23] 0 0
Barretos
Country [24] 0 0
Brazil
State/province [24] 0 0
Caxias do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
Jau
Country [26] 0 0
Brazil
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Sao Jose do Rio Preto
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
Vitoria
Country [29] 0 0
China
State/province [29] 0 0
Beijing
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China
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Chengdu
Country [31] 0 0
China
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Ganzhou
Country [32] 0 0
China
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Guangzhou
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China
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Hangzhou
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China
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Huizhou
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China
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Lanzhou
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China
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Nanchang
Country [37] 0 0
China
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Shanghai
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China
State/province [38] 0 0
Tianjin
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China
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Wuhan
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France
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Avignon Cedex 9
Country [41] 0 0
France
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Pessac
Country [42] 0 0
France
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Poitiers Cedex
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
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Frankfurt am Main
Country [45] 0 0
Germany
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Munich
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Hong Kong
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Shatin
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Hungary
State/province [47] 0 0
Eger
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India
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Delhi
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India
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Hyderabad
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India
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Kolkata
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India
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Mumbai
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India
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Pune
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India
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Vellore
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Israel
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Beer Yaakov
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Tel Aviv Yafo
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Pisa
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Italy
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Rozzano
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Italy
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Udine
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Japan
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Chiba
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Japan
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Chuo Ku
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Japan
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Kashiwa
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Japan
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Nagoya Shi
Country [69] 0 0
Japan
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Osaka City
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Japan
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Osaka Sayama shi
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Japan
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Osaka-Shi
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Japan
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Suita-shi
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Japan
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Malaysia
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Georgetown
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Malaysia
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Ipoh
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Putrajaya
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Netherlands
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Amersfoort
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Tilburg
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Poland
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Biala Podlaska
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Bialystok
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Brzozow
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Gdansk
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Gliwice
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Lodz
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Olsztyn
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Opole
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Poland
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Warszawa
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Puerto Rico
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San Juan
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Romania
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Brasov
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Romania
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Bucuresti
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Romania
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Craiova
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Gothenburg
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Songkhla
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Turkey
State/province [116] 0 0
Ankara
Country [117] 0 0
Turkey
State/province [117] 0 0
Istanbul
Country [118] 0 0
Turkey
State/province [118] 0 0
Konya
Country [119] 0 0
Turkey
State/province [119] 0 0
Sakarya
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Hull
Country [121] 0 0
United Kingdom
State/province [121] 0 0
London
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Northwood

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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
Email 0 0
Participate-In-This-Study1@its.jnj.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06750094