Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511813-39-00 | Registry Identifier | CTIS (EU) | |
| 2019-004770-25 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| Innate Pharma | INDUSTRY |
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This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer
Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All Participants will be followed for survival after progression is confirmed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | Experimental | Participants will receive intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 every one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
| Placebo Q2W + Cetuximab 400 mg/m^2 | Active Comparator | Participants will receieve IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monalizumab | Drug | Participants will receive IV infusion of monalizumab as stated in arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set | The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2). | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Full Analysis Set (FAS) | The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status (OPC HPV positive or HPV-unrelated), WHO/ECOG PS (0 or 1) and number of prior lines of therapy in R/M setting (1 or 2). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger B Cohen, MD | Abramson Cancer Center, Perelman Center for Advanced Medicine | Principal Investigator |
| Jérôme Fayette, MD | Centre Leon Berard | Principal Investigator |
| Dario Ruscica, MD | AstraZeneca, Cambridge, UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85719 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151963 | Derived | Nowojewski A, Wheal A, Dott W, Ruscica D, Ghiorghiu S, Valastro B. Implementation of the Study Participant Feedback Questionnaire to understand participant experience in a phase 3 oncology clinical trial. BMJ Open. 2025 Oct 28;15(10):e094596. doi: 10.1136/bmjopen-2024-094596. |
| Label | URL |
|---|---|
| Redacted Statistical Analysis Plan | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of the timelines, please refer to the disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
A total of 370 participants were randomized (All randomized participants [ARP] set) in this study of which 368 participants received treatment. The analyses presented in this report are based on a clinical efficacy data cut-off (DCO) date of 11May2022, and clinical safety DCO date of 01Sep2022.
The study was conducted at study sites located in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Republic of Korea, Russia, Spain, Switzerland, Taiwan, United Kingdom, and United States of America.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | Participants received intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 every 1 week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2021 | Oct 30, 2023 |
Parallel study. Participants will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab.
Not provided
Not provided
Double blinded study
| Cetuximab | Drug | Participants will receive IV infusion of cetuximab as stated in arm description. |
|
|
| Placebo | Other | Participants will receive IV infusion of placebo as stated in arm description. |
|
| Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment in HPV-unrelated Analysis Set | PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing non-TLs (NTLs) or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting. | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Progression-Free Survival Per RECIST 1.1 by Investigator Assessment in FAS | PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status, WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting. | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set | The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of complete response (CR) or partial response (PR) as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome. | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Percentage of Participants With OR Per RECIST 1.1 in FAS | The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of CR or PR as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome. | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set | The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique. | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Duration of Response Per RECIST 1.1 in FAS | The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique. | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | Day 1 through 21.4 months (maximum observed duration) |
| Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs | Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology and clinical chemistry. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | Day 1 through 21.4 months (maximum observed duration) |
| Number of Participants With Abnormal Vital Signs Reported as TEAEs | Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | Day 1 through 21.4 months (maximum observed duration) |
| Number of Participants With Electrocardiograms (ECGs) Reported as TEAEs | Participants with Abnormal ECGs reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | Day 1 through 21.4 months (maximum observed duration) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Research Site | Westwood | Kansas | 66205 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Las Vegas | Nevada | 89169 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Philadelphia | Pennsylvania | 19111 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Houston | Texas | 77090 | United States |
| Research Site | CABA | 1426 | Argentina |
| Research Site | CABA | C1012AAR | Argentina |
| Research Site | CABA | C1426ANZ | Argentina |
| Research Site | Camperdown | 2050 | Australia |
| Research Site | Elizabeth Vale | 5112 | Australia |
| Research Site | Heidelberg | 3084 | Australia |
| Research Site | Melbourne | 3000 | Australia |
| Research Site | Linz | 4010 | Austria |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Namur | 5000 | Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Belo Horizonte | 30110-022 | Brazil |
| Research Site | Porto Alegre | 90560-030 | Brazil |
| Research Site | Rio de Janeiro | 22271-110 | Brazil |
| Research Site | São Paulo | 01321-001 | Brazil |
| Research Site | São Paulo | 01327-001 | Brazil |
| Research Site | São Paulo | 01509-900 | Brazil |
| Research Site | São Paulo | 04543-000 | Brazil |
| Research Site | Panagyurishte | 4500 | Bulgaria |
| Research Site | Plovdiv | 4004 | Bulgaria |
| Research Site | Sofia | 1527 | Bulgaria |
| Research Site | Victoria | British Columbia | V8R 6V5 | Canada |
| Research Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Montreal | Quebec | H3T 1E2 | Canada |
| Research Site | Avignon | 84918 | France |
| Research Site | Bordeaux | 33000 | France |
| Research Site | Clermont-Ferrand | 63011 | France |
| Research Site | Dijon | 21079 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Marseille | 13005 | France |
| Research Site | Montpellier | 34298 | France |
| Research Site | Strasbourg | 67033 | France |
| Research Site | Berlin | 12203 | Germany |
| Research Site | Essen | 45122 | Germany |
| Research Site | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Ulm | 89081 | Germany |
| Research Site | Würzburg | 97070 | Germany |
| Research Site | Athens | 11528 | Greece |
| Research Site | Chaïdári | 124 62 | Greece |
| Research Site | Thessaloniki | 54645 | Greece |
| Research Site | Brescia | 25123 | Italy |
| Research Site | Candiolo | 10060 | Italy |
| Research Site | Florence | 50134 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Modena | 41124 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 811-1395 | Japan |
| Research Site | Hiroshima | 734-8551 | Japan |
| Research Site | Isehara-shi | 259-1193 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kobe | 650-0017 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Okayama | 700-8558 | Japan |
| Research Site | Sayama | 589-8511 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Yokohama | 236-0004 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Maastricht | 6229 HX | Netherlands |
| Research Site | Nijmegen | 6525 GA | Netherlands |
| Research Site | Manila | 1000 | Philippines |
| Research Site | Pasig | 1605 | Philippines |
| Research Site | Quezon City | 1112 | Philippines |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Bydgoszcz | 85-796 | Poland |
| Research Site | Poznan | 61-866 | Poland |
| Research Site | Coimbra | 3000-075 | Portugal |
| Research Site | Porto | 4099-001 | Portugal |
| Research Site | Porto | 4200-319 | Portugal |
| Research Site | Vila Nova de Gaia | 4434-502 | Portugal |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Moscow Region | 143081 | Russia |
| Research Site | Obninsk | 249036 | Russia |
| Research Site | Saint Petersburg | 191014 | Russia |
| Research Site | Saint Petersburg | 195271 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Busan | 49267 | South Korea |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Goyang-si | 10408 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 110-744 | South Korea |
| Research Site | Seoul | 138-736 | South Korea |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Valencia | 46014 | Spain |
| Research Site | Basel | 4031 | Switzerland |
| Research Site | Bern | 3010 | Switzerland |
| Research Site | Lausanne | CH-1011 | Switzerland |
| Research Site | Changhua | 500 | Taiwan |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Taipei | 235 | Taiwan |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Research Site | Sutton | SM2 5PT | United Kingdom |
| Redacted Study Protocol | View source |
| Redacted CSR synopsis | View source |
| Placebo Q2W + Cetuximab 400 mg/m^2 |
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population included all participants randomized up to the safety DCO date of 01Sep2022.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| BG001 | Placebo Q2W + Cetuximab 400 mg/m^2 | Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set | The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2). | The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either oropharyngeal cancer (OPC) HPV negative or non OPC regardless of the HPV status. | Posted | Median | 95% Confidence Interval | Months | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
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| Secondary | Overall Survival in Full Analysis Set (FAS) | The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status (OPC HPV positive or HPV-unrelated), WHO/ECOG PS (0 or 1) and number of prior lines of therapy in R/M setting (1 or 2). | The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). | Posted | Median | 95% Confidence Interval | Months | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
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| Secondary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment in HPV-unrelated Analysis Set | PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing non-TLs (NTLs) or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting. | The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either OPC HPV negative or non OPC regardless of the HPV status. | Posted | Median | 95% Confidence Interval | Months | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
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| Secondary | Progression-Free Survival Per RECIST 1.1 by Investigator Assessment in FAS | PFS per RECIST 1.1 as assessed by the investigator is defined as time from randomization until date of RECIST 1.1-defined radiological progressive disease (PD) or death regardless of whether participant withdraws from therapy or received subsequent anticancer therapy prior to progression. PD: at least 20% increase in sum of diameters of target lesions (TLs), taking as reference the smallest sum on study (nadir) and sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. PFS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status, WHO/ECOG PS (0/1) and no. of prior lines of therapy in R/M setting. | The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). | Posted | Median | 95% Confidence Interval | Months | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
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| Secondary | Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set | The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of complete response (CR) or partial response (PR) as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome. | The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either OPC HPV negative or non OPC regardless of the HPV status. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome. | Posted | Number | Percentage of Participants | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With OR Per RECIST 1.1 in FAS | The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of CR or PR as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome. | The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome. | Posted | Number | Percentage of Participants | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set | The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique. | The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either OPC HPV negative or non OPC regardless of the HPV status. The DoR is assessed for only those participants who had OR. | Posted | Median | Inter-Quartile Range | Months | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response Per RECIST 1.1 in FAS | The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique. | The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). The DoR is assessed for only those participants who had OR. | Posted | Median | Inter-Quartile Range | Months | Baseline (-28 to -1) through 17.5 months (maximum observed duration) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022). | Posted | Count of Participants | Participants | Day 1 through 21.4 months (maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs | Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology and clinical chemistry. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022). | Posted | Count of Participants | Participants | Day 1 through 21.4 months (maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Vital Signs Reported as TEAEs | Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022). | Posted | Count of Participants | Participants | Day 1 through 21.4 months (maximum observed duration) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Electrocardiograms (ECGs) Reported as TEAEs | Participants with Abnormal ECGs reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first. | The Safety Analysis Set (SAS) included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022). | Posted | Count of Participants | Participants | Day 1 through 21.4 months (maximum observed duration) |
|
Day 1 through 21.4 months (maximum observed duration)
All-Cause Mortality (ACM) reports data for ARP set; AE/SAE data is reported for SAS. Two participants died in follow-up period in each arm, after consent withdrawal from study, so number of deaths reported in ACM is different than of participant flow. TEAEs: Events from first dose of study drug (SD) up to 90 days after last dose of SD received or up to start date of any subsequent anticancer therapy following discontinuation of SD or final safety DCO of 01Sep22, whichever occurred first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 120 | 247 | 77 | 246 | 213 | 246 |
| EG001 | Placebo Q2W + Cetuximab 400 mg/m^2 | Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 61 | 123 | 27 | 122 | 111 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stevens-johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pachymeningitis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thoracic haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tracheal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
Study enrolment was discontinued after the planned initial interim futility analysis (IA1) due to unlikelihood of achieving statistical significance for OS in the primary endpoint (HPV-unrelated). Therefore, symptoms, function, health-related quality of life (HRQoL), European Organization for Research and Treatment of Cancer (EORTC) scale/item score, pharmacokinetic (PK) parameters, immunogenicity, human leukocyte antigen E (HLA-E), and NKp46+ expression outcomes were not evaluated.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2022 | Oct 30, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709515 | monalizumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| OG001 | Placebo Q2W + Cetuximab 400 mg/m^2 | Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
|
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
|
| OG001 | Placebo Q2W + Cetuximab 400 mg/m^2 | Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
|
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
|
|
|
| OG001 | Placebo Q2W + Cetuximab 400 mg/m^2 | Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| Placebo Q2W + Cetuximab 400 mg/m^2 |
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
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