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Terminated by the sponsor
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To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to checkpoint inhibitor therapy in locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.
This is a Phase 1/2, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of SNS-301 delivered intradermally in addition to pembrolizumab in patients with locally advanced unresectable or metastatic/recurrent SCCHN. The trial population consists of patients with locally advanced unresectable or metastatic/recurrent SCCHN who are currently receiving checkpoint inhibitor (CPI) therapy (Cohort A) or are naïve to CPI therapy (Cohort B). Patients who are currently receiving CPI therapy must have a best response of stable disease (SD) or first evidence of progressive disease (PD) after a minimum of 12 weeks of treatment with a CPI. Patients receiving a CPI other than pembrolizumab will be switched over to pembrolizumab at the time of entering this study. Patients receiving pembrolizumab in the first line setting must be PD-L1 positive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNS-301 added to pembrolizumab | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNS-301 | Drug | Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab | Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0 | 12 weeks |
| Objective Response Rate by RECIST and iRECIST | Objective response rate based on best objective response during the study. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | 12 weeks |
| Duration of Response by RECIST 1.1 and iRECIST | Duration of response calculated from date of first response to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | 12 weeks |
| Disease Control Rate by RECIST 1.1 and iRECIST | Disease control rate calculated as the proportion of patients with stable disease or better. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. |
| Measure | Description | Time Frame |
|---|---|---|
| Antigen-specific Response | Measure levels at pretreatment, changes during treatment and at progression or end of study | 12 weeks |
| TCR Sequencing | Determine TCR diversity pretreatment, changes during treatment and at progression or end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Related Expression | Determine immune expression pretreatment, changes during treatment and at progression | 12 weeks |
| Tumor Specific Oncoproteins | Determine expression pretreatment, during treatment and at progression |
Inclusion Criteria:
Signed informed consent.
Be 18 years of age or older.
Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent SCCHN and meet the criteria of either Cohort A or B.
Cohort A: Patients with Ongoing CPI Therapy
Cohort B: Patients without Previous CPI Therapy
Have measurable disease by RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.
Have a life expectancy of ≥ 3 months.
Be willing to provide a pre-treatment tissue sample (archived or fresh).
Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment. For male patients: Agree that during the period specified above, men will not father a child. Male patients must remain abstinent, must be surgically sterile during the treatment period and for at least 180 days after the last dose of study treatment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramzi Melhem, MD | Sensei Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94143 | United States | ||
| Christiana Care |
Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.
Beginning 9 months and ending 36 months following article publication.
Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.
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Participants were required to provide archival biopsy material or have a fresh biopsy prior to dosing.
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| ID | Title | Description |
|---|---|---|
| FG000 | SNS-301 Added to Pembrolizumab |
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2020 | Aug 1, 2022 |
Not provided
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Open label
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| Pembrolizumab | Drug | Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. |
|
|
| 12 weeks |
| Progression Free Survival by RECIST 1.1 and iRECIST | Progression free survival calculated from the date of start of treatment to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | 12 weeks |
| Overall Survival | Overall survival calculated from date of treatment to date of death. | 36 months |
| 12 weeks |
| Immune Gene Transcript Profiling | Determine gene signature pretreatment, during treatment and at progression | 12 weeks |
| Profiling of Pro-inflammatory/Immunosuppressive Molecules | Measure levels at pretreatment, changes during treatment and at progression or end of study | 12 weeks |
| 12 weeks |
| ASPH Expression | Determine pretreatment expression, changes during treatment and at progression | 12 weeks |
| Cytokine/Chemokine Profiling | Determine cytokine/chemokine profile pretreatment, changes during treatment and at progression | 12 weeks |
| ctDNA | Determine ctDNA profile pretreatment, changes during treatment and at progression | 12 weeks |
| Newark |
| Delaware |
| 19713 |
| United States |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Alliance for Multispeciality Research | Kansas City | Missouri | 64114 | United States |
| Mt. Sinai | New York | New York | 10029 | United States |
| New Orleans Clinical Research | Knoxville | Tennessee | 37920 | United States |
| Clear Lake Specialties | Webster | Texas | 77598 | United States |
| University of Wisconsin | Madison | Wisconsin | 53715 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD |
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. |
| BG001 | SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy |
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. |
| 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, 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 |
|
| 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 | Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab | Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0 | Posted | Count of Participants | Participants | 12 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Objective Response Rate by RECIST and iRECIST | Objective response rate based on best objective response during the study. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | Posted | Count of Participants | Participants | 12 weeks |
| ||||||||||||||||||||||||||||||||
| Primary | Duration of Response by RECIST 1.1 and iRECIST | Duration of response calculated from date of first response to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | A total of 18 patients were evaluable in patients who had previous pembrolizumab group and 1 patient was evaluable in the CPI naive group. One patient had a partial response with a DOR of 48.3 weeks. All other patients had stable disease or has progressive disease at the 12 week timeframe. | Posted | Median | 95% Confidence Interval | weeks | 12 weeks |
| ||||||||||||||||||||||||||||||
| Primary | Disease Control Rate by RECIST 1.1 and iRECIST | Disease control rate calculated as the proportion of patients with stable disease or better. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | Posted | Number | participants | 12 weeks |
| ||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival by RECIST 1.1 and iRECIST | Progression free survival calculated from the date of start of treatment to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | 19/25 patients were evaluable for this assessment. | Posted | Count of Participants | Participants | 12 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Overall Survival | Overall survival calculated from date of treatment to date of death. | Study stopped prematurely; no patients were assessed at 36 months thus no data collected. At the time of termination, four deaths occurred in the patients previously receiving pembrolizumab group and no deaths in the CPI naive group. | Posted | 36 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Antigen-specific Response | Measure levels at pretreatment, changes during treatment and at progression or end of study | 16/25 patients were evaluable for this assessment. | Posted | Number | ASPH antigen-specific responders | 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | TCR Sequencing | Determine TCR diversity pretreatment, changes during treatment and at progression or end of study | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Immune Gene Transcript Profiling | Determine gene signature pretreatment, during treatment and at progression | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Profiling of Pro-inflammatory/Immunosuppressive Molecules | Measure levels at pretreatment, changes during treatment and at progression or end of study | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Immune Related Expression | Determine immune expression pretreatment, changes during treatment and at progression | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Tumor Specific Oncoproteins | Determine expression pretreatment, during treatment and at progression | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | ASPH Expression | Determine pretreatment expression, changes during treatment and at progression | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Cytokine/Chemokine Profiling | Determine cytokine/chemokine profile pretreatment, changes during treatment and at progression | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | ctDNA | Determine ctDNA profile pretreatment, changes during treatment and at progression | Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated. | Posted | 12 weeks |
|
AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
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 | SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD |
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. | 3 | 21 | 5 | 21 | 16 | 21 |
| EG001 | SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy |
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. | 0 | 4 | 1 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mouth hemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mass | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram QT prolongation | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The study stopped prematurely for lack of efficacy 25 patients were enrolled. Lab analyzes were not performed.
Submission of data for publication/presentation will be reviewed, coordinated and approved by Sensei in collaboration with the Investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alice Drumheller | Sensei Bio | 2404548027 | adrumheller@senseibio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2021 | Aug 1, 2022 | 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 |
|---|---|
| C582435 | pembrolizumab |
Not provided
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 |
|
|
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| OG001 | SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy |
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. |
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SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months. Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months. |
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