Not provided
Not provided
Not provided
Not provided
Interim analysis was negative
Not provided
Not provided
Not provided
Not provided
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Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.
This is a multicenter, open-label, Phase II, randomized, controlled study to determine the efficacy, safety, and other indicators of clinical and biological activity of the combination of danvatirsen and pembrolizumab as first-line treatment for R/M HNSCC.
After providing informed consent, patients will be assessed for eligibility during the screening phase of the study. All patients must be willing and able to provide a formalin fixed paraffin-embedded (FFPE) archival or fresh tumor sample collected during the screening period; a fresh biopsy is preferred if safe and feasible to obtain and consented to by the patient. Following the screening period, eligible patients will be randomized in a 2:1 ratio to danvatirsen + pembrolizumab or pembrolizumab monotherapy, respectively. Patients will receive treatment in 21-day cycles. Patients assigned to the pembrolizumab monotherapy arm will receive treatment until a criterion for discontinuation is met or a maximum of 24 months of treatment. Patients assigned to combination therapy will receive both treatments until a criterion for discontinuation is met or the patient has received a maximum of 24 months of treatment, after which they may remain on danvatirsen monotherapy.
Patients in both treatment arms will have radiologic tumor assessments every 6 weeks (±1 week), regardless of treatment delays, until objective disease progression, initiation of new anticancer treatment, death, withdrawal of consent, or end of study, whichever occurs first.
All patients who discontinue study treatment for any reason will have a safety follow-up visit 30 days (+7 days) after the last dose of study treatment and a follow-up for AEs 90 days (+7 days) after the last dose of pembrolizumab. Patients will be followed for survival at 12 week (±7 days) intervals until death or withdrawal of consent, whichever occurs first. Survival follow-up will continue until at least 15 months after the last patient is randomized in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danvatirsen plus pembrolizumab | Experimental | Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. |
|
| Pembrolizumab | Active Comparator | Pembrolizumab IV every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danvatirsen | Drug | Danvatirsen is a STAT3 targeting drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed ORR | Determine the ORR (Partial response [PR] + CR defined according to RECIST v1.1) as determined by the Investigator for the combination of danvatirsen and pembrolizumab compared with pembrolizumab alone | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as Assessed by CTCAE v5.0 | Adverse Events are assessed and graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0. | Up to 18 months |
| DOR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Nabil Saba, MD | Emory University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85719 | United States | ||
| University of California Irvine (UCI) |
From May 2023 through May 2025, 94 patients were screened, 69 met the eligibility criteria and were randomized. Of the 69 patients that started the treatment period (45 danvatirsen combination arm/24 pembrolizumab arm), 3 patients in the pembrolizumab arm discontinued the study before receiving treatment. 66 patients in total received treatment (45 danvatirsen combination/21 pembrolizumab)
Enrollment was open from May 2023 through May 2025. Patients were recruited from community based practices, research institutions and universities located in the United States, United Kingdom and South Korea.
An early assessment of response in patients with CPS ≥1 and <20 was performed and the response rate in this subgroup did not pass the minimum prespecified efficacy level, subsequently eligibility was restricted to patients with CPS ≥20.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Danvatirsen Plus Pembrolizumab | Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 | May 8, 2025 | Oct 1, 2025 |
Not provided
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Not provided
Not provided
Not provided
Not provided
| Pembrolizumab | Drug | Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 |
|
|
Duration of Response by RECIST v1.1
| Up to 18months |
| DCR & CR Rate | Disease control rate and complete response rate by RECIST v1.1 | Up to 18months |
| ORR in Tumors With CPS ≥20 and ≥ 50 | Overall response rate per RECIST v1.1 in tumors with CPS< 20, CPS ≥ 20 and CPS ≥ 50 | Up to 18months |
| DOR in Tumors With CPS ≥20 and ≥50 | Duration of response by RECIST v1.1 in tumors with CPS ≥ 20 and ≥50 | Up to 18months |
| PFS | Progression-free survival by RECIST v1.1, defined as the time from randomization to the first documentation of progressive disease (PD) or death from any cause, whichever comes first | Up to 18months |
| OS | Overall survival, defined as time from randomization to death from any cause | Up to 30months |
| Maximum Plasma Concentration | Maximum concentration recorded [Cmax]of danvatirsen at defined timepoints in the combination regimen | Up to 18 months |
| Trough Concentration | Trough concentration [Ctrough] of danvatirsen at defined timepoints in the combination regimen | Up to 18 months |
| Area Under the Plasma Concentration-time Curve | Area under the plasma concentration-time curve over the dosing interval [AUCtau] of danvatirsen at defined timepoints in the combination regimen | Up to 18 months |
| Time to Maximum Plasma Concentration | Time to maximum plasma concentration [Tmax]) after single and multiple doses at defined timepoints in the combination regimen | Up to 18 months |
| Immunogenicity of Danvatirsen | Anti-danvatirsen antibody titers at defined timepoints in the combination regimen | Up to 18 months |
| Irvine |
| California |
| 92617 |
| United States |
| TMPN Hunt Cancer Care | Torrance | California | 90505 | United States |
| University of California Los Angeles | Westwood, Los Angeles | California | 90024 | United States |
| University of Colorado Hospital (UCH) Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | United States |
| AMR Kansas City Oncology | Merriam | Kansas | 66204 | United States |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| University of Maryland Baltimore, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | United States |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45229 | United States |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | United States |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29605 | United States |
| UT Southwestern Medical Center/Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Kosin University College of Medicine - Kosin University Gospel Hospital (KUGH) | Busan | 602-702 | South Korea |
| Gyeongsang National University Hospital | Jinju | 52727 | South Korea |
| Korea University Medical Center (KUMC) | Seoul | 02841 | South Korea |
| The Catholic University of Korea - Eunpyeong St. Mary's Hospital | Seoul | South Korea |
| Saint James's University Hospital (SJUH) - St James's Institute of Oncology | Leeds | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Liverpool | United Kingdom |
| Barts Health MHS Trust (Barts and The London NHS Trust) - St Bartholomew's (Barts) Hospital | London | EC1A 7BE | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| East and North Hertfordshire NHS Trust, Lister Hospital | Northwood | HA6 2RN | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| FG001 | Pembrolizumab | Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 |
|
| COMPLETED | A total of 48 patients completed treatment per the protocol. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Danvatirsen Plus Pembrolizumab | Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 |
| BG001 | Pembrolizumab | Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| PD-L1 Combined Positive Score (CPS) | All patients were required to have a positive PD-L1 expression determined by a test approved by FDA or the national regulatory agency of the country in which the patient resided to be eligible for enrollment. The PD-L1 measurement was provided as a Combined Positive Score (CPS). The higher the CPS number, the more tumor/immune cells expressing PD-L1. Patients were stratified by their CPS value (<=19 and >=20). The patients with a CPS>= 20 were further categorized. | Count of Participants | Participants |
| |||||||||||||||||
| Human Papillomavirus (HPV) | HPV status as reported by study sites | Count of Participants | Participants |
| |||||||||||||||||
| Eastern Cooperative Group Performance Status (ECOG | An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the trial. | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed ORR | Determine the ORR (Partial response [PR] + CR defined according to RECIST v1.1) as determined by the Investigator for the combination of danvatirsen and pembrolizumab compared with pembrolizumab alone | Will include all patients who receive at least 1 dose of study treatment based on the treatment assigned at randomization. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events as Assessed by CTCAE v5.0 | Adverse Events are assessed and graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0. | The Safety Analysis will include all patients who receive at least 1 dose of study treatment based on the actual treatment received. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR | Duration of Response by RECIST v1.1 | Will include all patients who receive at least 1 dose of study treatment and whose best overall response was a CR or PR. | Posted | Median | 95% Confidence Interval | Months | Up to 18months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DCR & CR Rate | Disease control rate and complete response rate by RECIST v1.1 | Will include all patients that received at least 1 dose of study treatment. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. DCR and CR rates will be determined in all patients and within patients with a CPS >=20 | Posted | Count of Participants | Participants | Up to 18months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR in Tumors With CPS ≥20 and ≥ 50 | Overall response rate per RECIST v1.1 in tumors with CPS< 20, CPS ≥ 20 and CPS ≥ 50 | Will include all patients who receive at least 1 dose of study treatment based on the treatment assigned at randomization. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. ORR will be determined in patients with a CPS< 20, CPS >=20 and CPS>=50. | Posted | Count of Participants | Participants | Up to 18months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR in Tumors With CPS ≥20 and ≥50 | Duration of response by RECIST v1.1 in tumors with CPS ≥ 20 and ≥50 | Includes only patients that achieved a CR or PR. DOR is defined as the date of the patient's first best overall response of CR or PR to the earliest date of documented progression or to death if no prior evidence of disease progression. | Posted | Median | 95% Confidence Interval | Months | Up to 18months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS | Progression-free survival by RECIST v1.1, defined as the time from randomization to the first documentation of progressive disease (PD) or death from any cause, whichever comes first | PFS will be determined in all patients and in patients with a CPS>=20 who receive at least 1 dose of study treatment.45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 18months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS | Overall survival, defined as time from randomization to death from any cause | Data were not collected due to study termination prior to participants' assessment at the pre-specified time points | Posted | Up to 30months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration | Maximum concentration recorded [Cmax]of danvatirsen at defined timepoints in the combination regimen | An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur. | Posted | Up to 18 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Concentration | Trough concentration [Ctrough] of danvatirsen at defined timepoints in the combination regimen | An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur. | Posted | Up to 18 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve | Area under the plasma concentration-time curve over the dosing interval [AUCtau] of danvatirsen at defined timepoints in the combination regimen | An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur. | Posted | Up to 18 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration | Time to maximum plasma concentration [Tmax]) after single and multiple doses at defined timepoints in the combination regimen | An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur. | Posted | Up to 18 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity of Danvatirsen | Anti-danvatirsen antibody titers at defined timepoints in the combination regimen | An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the ADA analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur. | Posted | Up to 18 months |
|
|
Approximately 25 months
AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
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 | Danvatirsen Plus Pembrolizumab | Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 | 8 | 45 | 25 | 45 | 44 | 45 |
| EG001 | Pembrolizumab | Pembrolizumab IV every 3 weeks after the Danvatirsen dose. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 | 4 | 21 | 6 | 21 | 18 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukaemoid reaction | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Wrong product administered | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tracheal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
All data is owned by the Sponsor. Sponsor shall have right to first publication of the results of the Study. PI may publish after 18 months of study termination if no publication by the sponsor. Sponsor may have up to 120 days to review the publication and has the right for confidential information to be removed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Flamingo Therapeutics | 484 482 0007 | clinical@flamingotx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2025 | Oct 1, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000610954 | danvatirsen |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| 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 |
|
| United States |
|
| United Kingdom |
|
| >=20 |
|
| 20-49 |
|
| >=50 |
|
| Negative |
|
| Unknown |
|
| ECOG = 1 |
|
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