Metastatic Colorectal Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as third or fourth treatment line in subjects with progressive measurable metastatic colorectal cancer (mCRC).
Interventions
BIOLOGICALBAX69 + infusional 5-FU/LV
Study Part 1: Safety Run-in * Administered weekly as part of a 4 week treatment cycle * Intravenous injection
BIOLOGICALBAX69 + panitumumab
Study Part 1: Safety Run-in * Administered weekly as part of a 4 week treatment cycle * Intravenous injection
BIOLOGICALBAX69 + 5-FU/LV
Study Part 2: Administered weekly as part of a 4 week treatment cycle •Intravenous injection
DRUGStandard of Care
* Investigator's choice * Dose according to drug label
Sponsors
Baxalta now part of Shire
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of a signed informed consent 2. Male and female subjects 18 years of age and older at the time of screening 3. Subjects who progressed after receiving at least 2, but no more than 3, prior SoC treatment lines 4. Anticipated life expectancy \>3 months at the time of screening 5. Weight between 40 kg and 180 kg 6. Histologically or cytologically confirmed diagnosis of CRC 7. Metastatic CRC not amenable to surgical resection 8. Known KRAS and NRAS mutation status (if unknown status for either of these genes, and no archival tissues is available, a fresh tumor biopsy will be made) 9. At least 1 measurable lesion as defined by RECIST v1.1 10. ECOG PS of 0-2 11. Adequate hematological function, defined as: 1. Platelet count ≥ 100,000/μL 2. Prothrombin time and activated partial thromboplastin time (aPTT) \< 1.5 times the upper limit of normal (ULN) 3. Absolute neutrophil count (ANC) ≥ 1,000/μL 4. Hemoglobin ≥ 9 g/dL, without the need for transfusion in the 2 weeks prior to screening 12. Adequate renal function, defined as serum creatinine ≤ 2.0 times ULN and creatinine clearance \> 50 mL/min 13. Adequate liver function, defined as: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN for subjects without liver metastases, or ≤ 5 times ULN in the presence of liver metastases 2. Bilirubin ≤ 2.0 times ULN, unless subject has known Gilbert's syndrome 14. Adequate venous access 15. For female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control measures, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or \[for male partner\] condom) throughout the course of the study and for at least 90 days after the last administration of BAX69. Other acceptable contraceptive measures include birth control pills/patches or intrauterine devices 16. For male subjects, the subject must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and \[for the female partner\] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of BAX69 17. Subject is willing and able to comply with the requirements of the protocol.
Exclusion criteria
1. Known central nervous system metastases 2. Prior malignancy(s) within the past 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin, locally advanced prostate cancer, ductal carcinoma in situ of breast, in situ cervical carcinoma and superficial bladder cancer 3. Prior treatment with panitumumab for subjects with KRAS and NRAS wt tumor 4. Residual AE from previous treatment \> Grade 1 5. Prior intolerance to fluoropyrimidine for subjects with KRAS or NRAS mut tumor 6. Myocardial infarction within 6 months prior to C1D1, and/or prior diagnoses of congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or long QT syndrome) 7. Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg confirmed upon repeated measures 8. LVEF \< 40% as determined by echocardiogram performed at screening or within 90 days prior to C1D1 9. QT/QTc interval \> 450 msec, as determined by screening ECG performed no earlier than 1 week before C1D1 10. Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within 4 weeks prior to C1D1. 11. Major surgery within 4 weeks prior to C1D1 12. Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints 13. Active infection involving IV antibiotics within 2 weeks prior to C1D1 14. Known history of, or active hepatitis B virus (HBV), hepatitis C virus (HCV) or active tuberculosis 15. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease 16. Subject has received a live vaccine within 4 weeks prior to C1D1 17. Known hypersensitivity to any component of recombinant protein production by CHO cells 18. Exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study 19. Subject is nursing or intends to begin nursing during the course of the study 20. Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study 21. Subject is a family member or employee of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Progression-Free Survival (PFS) | From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression | PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent. |
| Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT) | From start of study treatment up to 28 days | DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any \>= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of \<3 days duration; nausea and vomiting \<3 days duration; fatigue of \<7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to \<= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for \<= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | From start of study drug administration up to EOT (approximately 21 Months) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. TEAEs was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. |
| Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Day 28 of Cycle 2 followed by every 2 Cycles of 28 day Cycles: Day 56, Day 112, Day 168 and Day 224 | Number of participants with response evaluation according to RECIST v1.1 was evaluated according to complete response (CR): disappearance of all target and non-target lesions and no new lesions; partial response (PR): \>= 30 percent (%) decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; stable disease (SD): neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; progressive disease (PD): \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5 millimeter (mm) (compared to the previous minimum sum) or progression of a new lesion. |
| Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | From start of study drug administration up to end of treatment (EOT) (approximately 21 Months) | Number of participants with occurrence of binding and/or neutralizing anti-imalumab antibodies were reported. |
| Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline, 21 Months (EOT) up to follow-up | EORTC QLQ-C30 was a validated instrument used to measure QoL and assess symptoms and side effects of treatment and the impact on everyday life.The QLQ-C30 was composed of: A) 5 multi-item functioning scales(physical, role, social, emotional and cognitive), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a higher level of functioning and a better QoL. B) A global health status/QoL scale that was answered on a 7-point scale (1=Very Poor to 7=Excellent). Each score range from 0 to 100 with a higher score representing a better QoL. C) 9 symptom scales(fatigue, nausea/vomiting,pain,financial impact/difficulties,appetite loss,diarrhea, constipation,sleep disturbance/insomnia and dyspnea), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a greater degree of symptoms and a worse QoL. |
| Overall Survival | From start of study drug administration up to EOT (approximately 21 Months) | Overall survival was defined as the time from randomization until death due to any cause. Here, number of participants analyzed was based on the number of participants who underwent death. |
| Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | From start of study drug administration up to EOT (approximately 21 Months) | Infusion reaction was defined as any relevant sign or symptom occurring during or after imalumab infusion and considered by the investigator as an infusion reaction. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 21 centers in the United States, the United Kingdom and Spain between 15 June 2015 (first participant first visit) and 15 February 2017 (last participant last visit).
Pre-assignment details
Overall (part 1 and 2) 115 participants were screened, 85 participants were randomized and 79 participants were treated. In part 1, 17 participants were screened, 5 failed screening, 12 were randomized and treated. In part 2, 98 participants were screened, 17 failed screening and 8 did not start the study, 73 were randomized and 67 were treated.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 3 |
| Part 1: Imalumab 7.5 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 3 |
| Part 1: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 3 |
| Part 1: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 3 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m\^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m\^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 31 |
| Part 2: Standard of Care Mutant Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 16 |
| Part 2: Imalumab 10 mg/kg + Panitumumab Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 18 |
| Part 2: Standard of Care Wild Type Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. | 8 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other (Progressive disease) | 2 | 2 | 0 | 3 | 23 | 9 | 14 | 5 |
| Overall Study | Other (study terminated by sponsor) | 0 | 0 | 0 | 0 | 4 | 2 | 2 | 1 |
| Overall Study | Other (unspecified) | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 3 | 5 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Part 1: Imalumab 7.5 mg/kg + Panitumumab | Part 1: Imalumab 7.5 mg/kg + 5-FU/LV | Part 1: Imalumab 10 mg/kg + 5-FU/LV | Part 1: Imalumab 10 mg/kg + Panitumumab | Part 2: Imalumab 10 mg/kg + 5-FU/LV | Part 2: Standard of Care Mutant | Part 2: Imalumab 10 mg/kg + Panitumumab | Part 2: Standard of Care Wild Type |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 10 Participants | 4 Participants | 5 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 21 Participants | 12 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 2 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 26 Participants | 14 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 74 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 26 Participants | 14 Participants | 18 Participants | 6 Participants |
| Sex: Female, Male Female | 33 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 13 Participants | 5 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 52 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 18 Participants | 11 Participants | 11 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 10 / 29 | 7 / 13 | 4 / 18 | 2 / 7 |
| other Total, other adverse events | 2 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 28 / 29 | 12 / 13 | 17 / 18 | 7 / 7 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 1 / 3 | 2 / 3 | 15 / 29 | 8 / 13 | 7 / 18 | 2 / 7 |
Outcome results
Primary
Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT)
DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any \>= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of \<3 days duration; nausea and vomiting \<3 days duration; fatigue of \<7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to \<= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for \<= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03.
Time frame: From start of study treatment up to 28 days
Population: SAS included all participants who received at least 1 administration of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT) | 0 Participants |
| Part 2: Standard of Care Mutant | Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT) | 0 Participants |
| Part 2: Standard of Care Wild Type | Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT) | 0 Participants |
Primary
Part 2: Progression-Free Survival (PFS)
PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.
Time frame: From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression
Population: Full analysis set (FAS) included all participants who received at least 1 administration of study drug, and who had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Part 2: Progression-Free Survival (PFS) | 11.1 weeks |
| Part 2: Standard of Care Mutant | Part 2: Progression-Free Survival (PFS) | 8.3 weeks |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Part 2: Progression-Free Survival (PFS) | 9.3 weeks |
| Part 2: Standard of Care Wild Type | Part 2: Progression-Free Survival (PFS) | 7.3 weeks |
p-value: 0.24670% CI: [0.5, 1.1]Log Rank
p-value: 0.35470% CI: [0.5, 1.4]Log Rank
Secondary
Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30 was a validated instrument used to measure QoL and assess symptoms and side effects of treatment and the impact on everyday life.The QLQ-C30 was composed of: A) 5 multi-item functioning scales(physical, role, social, emotional and cognitive), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a higher level of functioning and a better QoL. B) A global health status/QoL scale that was answered on a 7-point scale (1=Very Poor to 7=Excellent). Each score range from 0 to 100 with a higher score representing a better QoL. C) 9 symptom scales(fatigue, nausea/vomiting,pain,financial impact/difficulties,appetite loss,diarrhea, constipation,sleep disturbance/insomnia and dyspnea), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a greater degree of symptoms and a worse QoL.
Time frame: Baseline, 21 Months (EOT) up to follow-up
Population: SAS included all participants who received at least 1 administration of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 33.34 score on a scale | Standard Deviation 47.143 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | -0.01 score on a scale | Standard Deviation 47.143 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 44.45 score on a scale | Standard Deviation 38.492 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 50 score on a scale | Standard Deviation 50 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | -25 score on a scale | Standard Deviation 35.355 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 79.67 score on a scale | Standard Deviation 26.274 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | 33.33 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -7 score on a scale | Standard Deviation 13.675 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 83.33 score on a scale | Standard Deviation 16.665 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | 8.33 score on a scale | Standard Deviation 35.355 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 77.78 score on a scale | Standard Deviation 25.458 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | -8.34 score on a scale | Standard Deviation 11.787 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 29.67 score on a scale | Standard Deviation 28.015 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 33.33 score on a scale | Standard Deviation 16.665 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 44.50 score on a scale | Standard Deviation 15.797 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | 16.67 score on a scale | Standard Deviation 23.568 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | 25 score on a scale | Standard Deviation 11.78 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 63.33 score on a scale | Standard Deviation 26.031 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 66.67 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 38.89 score on a scale | Standard Deviation 38.486 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 41.66 score on a scale | Standard Deviation 35.355 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 97.22 score on a scale | Standard Deviation 4.809 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 66.67 score on a scale | Standard Deviation 0 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 38.492 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 88.89 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 88.89 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 75.56 score on a scale | Standard Deviation 19.249 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 29.66 score on a scale | Standard Deviation 6.351 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 27.78 score on a scale | Standard Deviation 9.619 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 66.7 score on a scale | Standard Deviation 8.335 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 72.22 score on a scale | Standard Deviation 9.619 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 33.33 score on a scale | Standard Deviation 33.335 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | -16.67 score on a scale | Standard Deviation 16.67 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 91.67 score on a scale | Standard Deviation 8.335 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | 5.55 score on a scale | Standard Deviation 9.619 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -5.56 score on a scale | Standard Deviation 17.346 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 100 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | -5.56 score on a scale | Standard Deviation 4.812 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 88.89 score on a scale | Standard Deviation 7.696 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 77.78 score on a scale | Standard Deviation 9.619 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 22.22 score on a scale | Standard Deviation 38.492 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 16.67 score on a scale | Standard Deviation 16.665 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | -22.22 score on a scale | Standard Deviation 9.63 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 22.33 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 29.45 score on a scale | Standard Deviation 23.089 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | -11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 0 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | 33.34 score on a scale | Standard Deviation 33.335 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 5.56 score on a scale | Standard Deviation 9.624 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 33.33 score on a scale | Standard Deviation 0 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | -2.22 score on a scale | Standard Deviation 7.699 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 75 score on a scale | Standard Deviation 8.33 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 44.44 score on a scale | Standard Deviation 50.918 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 83.33 score on a scale | Standard Deviation 16.665 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 77.78 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 77.78 score on a scale | Standard Deviation 9.619 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | -16.67 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | -20 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | -33.33 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 16.67 score on a scale | Standard Deviation 16.665 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 66.67 score on a scale | Standard Deviation 16.665 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | -33.34 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 38.89 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 26 score on a scale | Standard Deviation 6.351 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 22.22 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | 0 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 44.34 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 44.44 score on a scale | Standard Deviation 19.249 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 80 score on a scale | Standard Deviation 6.67 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | 0 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | -16.66 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 66.67 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -41.66 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | 0 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 11.11 score on a scale | Standard Deviation 19.243 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 33.33 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 83.33 score on a scale | Standard Deviation 16.665 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 0 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | -33.33 score on a scale | — |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 0 score on a scale | — |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 18.39 score on a scale | Standard Deviation 30.324 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | 8.77 score on a scale | Standard Deviation 33.04 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 10.34 score on a scale | Standard Deviation 18.046 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 7.41 score on a scale | Standard Deviation 33.442 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 88.69 score on a scale | Standard Deviation 15.08 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 11.90 score on a scale | Standard Deviation 20.716 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | -1.85 score on a scale | Standard Deviation 15.003 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | 7.84 score on a scale | Standard Deviation 34.421 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 88.10 score on a scale | Standard Deviation 18.063 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 5.56 score on a scale | Standard Deviation 20.612 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | -1.75 score on a scale | Standard Deviation 25.996 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | -13.89 score on a scale | Standard Deviation 25.726 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | -13.16 score on a scale | Standard Deviation 23.293 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 17.24 score on a scale | Standard Deviation 26.157 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 78.45 score on a scale | Standard Deviation 18.67 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 5.55 score on a scale | Standard Deviation 21.39 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 68.10 score on a scale | Standard Deviation 18.51 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | -5 score on a scale | Standard Deviation 17.198 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -3.24 score on a scale | Standard Deviation 15.163 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 33.74 score on a scale | Standard Deviation 20.645 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 31.55 score on a scale | Standard Deviation 27.719 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 25 score on a scale | Standard Deviation 33.488 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | -12.04 score on a scale | Standard Deviation 24.122 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 78.87 score on a scale | Standard Deviation 18.494 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 23.46 score on a scale | Standard Deviation 28.964 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 13.10 score on a scale | Standard Deviation 22.843 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 9.28 score on a scale | Standard Deviation 19.828 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 74.41 score on a scale | Standard Deviation 24.63 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | 2.78 score on a scale | Standard Deviation 24.421 |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 9.26 score on a scale | Standard Deviation 29.826 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 20.51 score on a scale | Standard Deviation 25.599 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | -13.54 score on a scale | Standard Deviation 21.333 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 81.15 score on a scale | Standard Deviation 15.537 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | -21.04 score on a scale | Standard Deviation 23.489 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 73.08 score on a scale | Standard Deviation 30.076 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | -16.67 score on a scale | Standard Deviation 43.642 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 73.08 score on a scale | Standard Deviation 25.72 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -1.04 score on a scale | Standard Deviation 16.925 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 89.74 score on a scale | Standard Deviation 14.496 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | -27.08 score on a scale | Standard Deviation 30.779 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 80.77 score on a scale | Standard Deviation 24.387 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | -25 score on a scale | Standard Deviation 15.43 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 38.46 score on a scale | Standard Deviation 28.58 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 23.63 score on a scale | Standard Deviation 19.197 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 6.41 score on a scale | Standard Deviation 10.841 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | 14.58 score on a scale | Standard Deviation 20.773 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 23.08 score on a scale | Standard Deviation 30.074 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 12.50 score on a scale | Standard Deviation 21.362 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 62.18 score on a scale | Standard Deviation 25.371 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 16.67 score on a scale | Standard Deviation 30.861 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 20.51 score on a scale | Standard Deviation 25.599 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | 12.50 score on a scale | Standard Deviation 30.537 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 33.33 score on a scale | Standard Deviation 38.49 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 4.17 score on a scale | Standard Deviation 27.82 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 25.64 score on a scale | Standard Deviation 30.895 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 16.67 score on a scale | Standard Deviation 43.645 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 20.51 score on a scale | Standard Deviation 34.798 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | 8.33 score on a scale | Standard Deviation 38.834 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 25.64 score on a scale | Standard Deviation 33.758 |
| Part 2: Standard of Care Mutant | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | -12.50 score on a scale | Standard Deviation 24.801 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 17.149 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 93.14 score on a scale | Standard Deviation 10.306 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 29.63 score on a scale | Standard Deviation 19.041 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -2.78 score on a scale | Standard Deviation 16.792 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 7.41 score on a scale | Standard Deviation 11.746 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 66.18 score on a scale | Standard Deviation 22.529 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 17.65 score on a scale | Standard Deviation 26.66 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | 0 score on a scale | Standard Deviation 38.924 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 77.45 score on a scale | Standard Deviation 19.49 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | -10.42 score on a scale | Standard Deviation 17.81 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | -11.54 score on a scale | Standard Deviation 29.957 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 22.22 score on a scale | Standard Deviation 28.005 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 12.96 score on a scale | Standard Deviation 20.256 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | -11.11 score on a scale | Standard Deviation 16.411 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 6.41 score on a scale | Standard Deviation 19.882 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 76.85 score on a scale | Standard Deviation 19.078 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 73.53 score on a scale | Standard Deviation 29.498 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | -4.10 score on a scale | Standard Deviation 10.379 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 7.69 score on a scale | Standard Deviation 24.165 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 78.89 score on a scale | Standard Deviation 20.612 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | -5.56 score on a scale | Standard Deviation 12.976 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 22.22 score on a scale | Standard Deviation 25.566 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | -8.33 score on a scale | Standard Deviation 15.075 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | 5.13 score on a scale | Standard Deviation 30.72 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 17.95 score on a scale | Standard Deviation 17.296 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 2.56 score on a scale | Standard Deviation 34.591 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 14.81 score on a scale | Standard Deviation 26.127 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 19.61 score on a scale | Standard Deviation 23.743 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | 7.69 score on a scale | Standard Deviation 14.616 |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 3.44 score on a scale | Standard Deviation 21.919 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale (CFB) | -6.67 score on a scale | Standard Deviation 27.886 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (Baseline) | 35.71 score on a scale | Standard Deviation 29.546 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (CFB) | 10 score on a scale | Standard Deviation 14.906 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (Baseline) | 28.57 score on a scale | Standard Deviation 23.003 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (Baseline) | 14.28 score on a scale | Standard Deviation 17.816 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Nausea/vomiting symptom scale (Baseline) | 4.76 score on a scale | Standard Deviation 8.134 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (CFB) | 13.33 score on a scale | Standard Deviation 18.209 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (change from baseline (CFB)) | -11.67 score on a scale | Standard Deviation 9.502 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Appetite loss symptom scale (CFB) | 20 score on a scale | Standard Deviation 29.816 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Fatigue symptom scale (Baseline) | 41.24 score on a scale | Standard Deviation 21.943 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (CFB) | -10 score on a scale | Standard Deviation 19.004 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (Baseline) | 19.05 score on a scale | Standard Deviation 26.227 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Social functioning scale (Baseline) | 66.67 score on a scale | Standard Deviation 27.215 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (CFB) | -6.67 score on a scale | Standard Deviation 9.128 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Global Health Status (Baseline) | 59.52 score on a scale | Standard Deviation 19.501 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Constipation symptom scale (CFB) | 6.67 score on a scale | Standard Deviation 27.886 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cognitive functioning scale (Baseline) | 83.33 score on a scale | Standard Deviation 23.571 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (CFB) | -11.66 score on a scale | Standard Deviation 20.916 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Emotional functioning scale (Baseline) | 66.66 score on a scale | Standard Deviation 18.003 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (Baseline) | 23.81 score on a scale | Standard Deviation 25.198 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (CFB) | -10 score on a scale | Standard Deviation 14.91 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Role functioning scale (Baseline) | 66.67 score on a scale | Standard Deviation 25.459 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Financial impact symptom scale (CFB) | 20 score on a scale | Standard Deviation 18.259 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Diarrhea symptom scale (CFB) | 0 score on a scale | Standard Deviation 23.568 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (CFB) | -14.67 score on a scale | Standard Deviation 15.918 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Physical functioning scale (Baseline) | 70 score on a scale | Standard Deviation 17.95 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Sleep disturbance/insomnia symptom scale(Baseline) | 47.62 score on a scale | Standard Deviation 42.415 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (CFB) | 6.67 score on a scale | Standard Deviation 27.886 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Dyspnea symptom scale (Baseline) | 9.52 score on a scale | Standard Deviation 16.263 |
| Part 2: Standard of Care Wild Type | Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Pain symptom scale (CFB) | 13.33 score on a scale | Standard Deviation 18.258 |
Secondary
Number of Participants With Incidence of Infusion Reactions After Imalumab Administration
Infusion reaction was defined as any relevant sign or symptom occurring during or after imalumab infusion and considered by the investigator as an infusion reaction.
Time frame: From start of study drug administration up to EOT (approximately 21 Months)
Population: SAS included all participants who received at least 1 administration of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 1 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Incidence of Infusion Reactions After Imalumab Administration | 0 Participants |
Secondary
Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies
Number of participants with occurrence of binding and/or neutralizing anti-imalumab antibodies were reported.
Time frame: From start of study drug administration up to end of treatment (EOT) (approximately 21 Months)
Population: SAS included all participants who received at least 1 administration of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 1 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 1 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Binding antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | End of Study (Neutralizing antibody) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies | Baseline (Binding antibody) | 0 Participants |
Secondary
Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Number of participants with response evaluation according to RECIST v1.1 was evaluated according to complete response (CR): disappearance of all target and non-target lesions and no new lesions; partial response (PR): \>= 30 percent (%) decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; stable disease (SD): neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; progressive disease (PD): \>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \>=5 millimeter (mm) (compared to the previous minimum sum) or progression of a new lesion.
Time frame: Day 28 of Cycle 2 followed by every 2 Cycles of 28 day Cycles: Day 56, Day 112, Day 168 and Day 224
Population: FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 2 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 1 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 2 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 1 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 1 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 2 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 2 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 1 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 15 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 14 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 1 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 0 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 4 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 7 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 3 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 6 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 1 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 8 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Stable Disease (SD) | 2 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Progressive Disease (PD) | 4 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Partial Response (PR) | 1 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Complete Response (CR) | 0 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Best Overall Response: Not Evaluable (NE) | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. TEAEs was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
Time frame: From start of study drug administration up to EOT (approximately 21 Months)
Population: SAS included all participants who received at least 1 administration of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 1 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 3 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 1 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 3 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 1 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 3 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 2 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 3 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 15 Participants |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 28 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 8 Participants |
| Part 2: Standard of Care Mutant | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 13 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 17 Participants |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 7 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | SAEs | 2 Participants |
| Part 2: Standard of Care Wild Type | Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs) | TEAEs | 7 Participants |
Secondary
Overall Survival
Overall survival was defined as the time from randomization until death due to any cause. Here, number of participants analyzed was based on the number of participants who underwent death.
Time frame: From start of study drug administration up to EOT (approximately 21 Months)
Population: FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Overall Survival | 24.9 weeks |
| Part 2: Standard of Care Mutant | Overall Survival | 42.7 weeks |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Overall Survival | 42.7 weeks |
| Part 2: Standard of Care Wild Type | Overall Survival | 24.9 weeks |
| Part 2: Imalumab 10 mg/kg + 5-FU/LV | Overall Survival | 31.9 weeks |
| Part 2: Standard of Care Mutant | Overall Survival | 27.2 weeks |
| Part 2: Imalumab 10 mg/kg + Panitumumab | Overall Survival | 31.4 weeks |
| Part 2: Standard of Care Wild Type | Overall Survival | NA weeks |