| Primary | Percentage of Participants With Confirmed Best Objective Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 Assessed by Investigator | Confirmed BOR was defined as the percentage of participants who achieved confirmed complete responses (CR) or partial response (PR), according to RECIST version 1.1 assessed by the Investigator.CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)= Neither sufficient increase to qualify for progression of disease (PD) nor sufficient shrinkage to qualify for PR. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Confirmed CR=as at least two determinations of CR at least 4 weeks apart with no PD. Confirmed PR=as at least 2 determinations of PR or better (PR followed by PR or PR followed by CR), at least 4 weeks apart (not qualifying for a CR) with no PD in between. Percentage of Participants with confirmed BOR were reported. | Full analysis set includes all participants who received at least one non-zero dose of any study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Time from the first dose of study drug until occurrence of PD, death due to any cause (assessed up to 612 days) | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (AEs), Treatment-Related Grade >=3 TEAEs and Immune-related Treatment Emergent AEs (irTEAEs) | Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug.Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious and non-serious TEAEs. irAEs included AEs that matches a preferred term on the list of pre-selected MedDRA terms. AEs with relationship to study treatment are reported as Treatment-related AEs. Treatment related AEs with grade 3 or more is also reported. | Safety analysis set included all participants who received at least one non-zero dose of any study treatment. | Posted | | Count of Participants | | Participants | | Time from the first dose of study drug assessed up to (941 days) | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Progression free survival (PFS) is defined as the time (in months) from first treatment day to the date of the first documentation of objective progression of disease (PD) according to RECIST version 1.1 assessed by Investigator, or death due to any cause, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Full analysis set includes all participants who received at least one non-zero dose of any study treatment. | Posted | | Median | 95% Confidence Interval | Months | | Time from the first dose of study drug until occurrence of PD, death due to any cause (assessed up to 737 days) | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Duration of Response (DOR) | DOR is defined for participants with confirmed complete response (CR) or partial response (PR), as the time from first documentation of confirmed response to the date of first documentation of progression of disease (PD) according to RECIST version 1.1 (assessed by Investigator) or death due to any cause or tumor assessment. Duration of objective response was assessed using Kaplan-Meier analysis. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Full analysis set included all participants who receive at least one non-zero dose of any study treatment. Here "Overall number of participants analyzed" signifies those participants who had confirmed CR or PR. | Posted | | Median | 95% Confidence Interval | Months | | Time from the first dose of study drug until occurrence of PD, death due to any cause or last tumor assessment (assessed up to 612 days) | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Avelumab | Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed Avelumab concentration-time data. | Pharmacokinetic (PK) analysis set included all participants who receive at least one dose of avelumab and/or cetuximab, have no important events affecting PK, and provide at least one measurable post-dose concentration. Number of Participants Analyzed=participants evaluable for this outcome and Number analyzed=participants evaluated at specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | | Pre-dose, 2 hours after end of infusion on Day 1, 8, 22 and 29; Pre-dose, 30 minutes after the end of infusion on Day 43, 50, 64, 71; Pre-dose, 3 hours after end of infusion on Day 85, 99, 113, 127, 169, 253, and 337 | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Cetuximab | Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed cetuximab concentration-time data. | PK analysis set included all participants who receive at least one dose of avelumab and/or cetuximab, have no important events affecting PK, and provide at least one measurable post-dose concentration. Number analyzed=participants evaluated at specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 2 hours after end of infusion on Day 1, 8, 22 and 29; Pre-dose, 30 minutes after the end of infusion on Day 43, 50, 64, 71; Pre-dose, 3 hours after end of infusion on Day 85, 99, 113, 127, 169, 253, and 337 | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Serum Trough Concentration Levels (Ctrough) of Avelumab | Ctrough is the serum concentration observed immediately before next dosing. | PK analysis set included all participants who receive at least one dose of avelumab and/or cetuximab, have no important events affecting PK, and provide at least one measurable post-dose concentration. Number of Participants Analyzed=participants evaluable for this outcome and Number analyzed=participants evaluated at specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 99, Day 113, Day 127, Day 169, Day 253 and Day 337 | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Serum Trough Concentration Levels (Ctrough) of Cetuximab | Ctrough is the serum concentration observed immediately before next dosing. | PK analysis set included all participants who receive at least one dose of avelumab and/or cetuximab, have no important events affecting PK, and provide at least one measurable post-dose concentration. Number of Participants Analyzed=participants evaluable for this outcome and Number analyzed=participants evaluated at specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 99, Day 113, Day 127, Day 169, Day 253 and Day 337 | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the first treatment day to the date of death due to any cause. Overall survival was assessed using Kaplan-Meier analysis. | Full analysis set includes all participants who received at least one non-zero dose of any study treatment. | Posted | | Median | 95% Confidence Interval | Months | | Time from the first dose of study drug until occurrence of death due to any cause (assessed up to 941 days) | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) of Avelumab | The detection of antibodies to avelumab was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of avelumab were reported. | ADA analysis set included all participants who received at least 1 dose of avelumab and/or cetuximab and have at least 1 valid ADA result. | Posted | | Count of Participants | | Participants | | Pre-dose up to 149 days | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) of Cetuximab | The detection of antibodies to cetuximab was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of cetuximab were reported. | ADA analysis set included all participants who received at least 1 dose of avelumab and/or cetuximab and have at least 1 valid ADA result. | Posted | | Count of Participants | | Participants | | Pre-dose up to 149 days | | | | ID | Title | Description |
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| OG000 | Avelumab and Cetuximab | Participants received 800 milligrams Avelumab, 1250 milligrams per square meter (mg/m^2) gemcitabine on Day 1 and Day 8, cisplatin at a dose of 75 mg/m^2 on Day 1 along with 250 mg/m2 body surface area Cetuximab on Day 1 and 500 mg/m2 body surface area on Day 8 of each cycle as intravenous (IV) infusions up to maximum of 4 cycles (each cycle is of 3 weeks) until disease progression or unacceptable toxicities. In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles. Subsequently participants were administered with avelumab and cetuximab as IV infusion at the dose of 800 mg and 500 mg/m^2 respectively, every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities. |
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