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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.
Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib & Dostarlimab | Experimental | Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib & Dostarlimab combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response | Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Measured using Kaplan Meier Curves from time of treatment start until time of progression | 1 and 3 years |
| Overall Survival | Measured using Kaplan Meier Curves from diagnosis until time of death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trisha Wise-Draper, MD, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Niraparib & Dostarlimab | Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks. Niraparib: Niraparib & Dostarlimab combination Dostarlimab: Niraparib & Dostarlimab combination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Niraparib & Dostarlimab | Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks. Niraparib: Niraparib & Dostarlimab combination Dostarlimab: Niraparib & Dostarlimab combination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overall Response | Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab. | Posted | Count of Participants | Participants | 8 weeks |
|
|
Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Niraparib & Dostarlimab | Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks. Niraparib: Niraparib & Dostarlimab combination Dostarlimab: Niraparib & Dostarlimab combination |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trisha Wise-Draper M.D., Ph.D. | University of Cincinnati | (513) 558-2826 | wiseth@ucmail.uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2021 | Aug 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| C000719628 | dostarlimab |
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| Dostarlimab | Drug | Niraparib & Dostarlimab combination |
|
|
| Through study completion, an average of 10 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG | ECOG Performance Status, assessed by the PI or designee at clinical evaluation, measures a participant's ability to care for themselves and perform daily activities. Scores range from 0 (fully active) to 4 (completely disabled). Inclusion required ECOG 0 or 1 at registration. Lower scores (0-1) reflect better clinical outcomes and higher functional status. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Progression Free Survival | Measured using Kaplan Meier Curves from time of treatment start until time of progression | 10 eligible participants that received one prior line of treatment in the recurrent/metastatic setting, with all but one patient having previously failed a PD-1 or PD-L1 inhibitor | Posted | Median | 95% Confidence Interval | months | 1 and 3 years |
|
|
|
| Secondary | Overall Survival | Measured using Kaplan Meier Curves from diagnosis until time of death | 10 eligible participants that received one prior line of treatment in the recurrent/metastatic setting, with all but one patient having previously failed a PD-1 or PD-L1 inhibitor | Posted | Median | 95% Confidence Interval | months | Through study completion, an average of 10 months |
|
|
|
| 9 |
| 10 |
| 6 |
| 10 |
| 10 |
| 10 |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Oropharyngeal Hemorrhage | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Tracheal obstruction | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Tracheostomy site bleeding | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE version 5 | Systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE version 5 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE version 5 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Blurred vision | Eye disorders | CTCAE version 5 | Systematic Assessment |
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| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
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| Chills | General disorders | CTCAE version 5 | Systematic Assessment |
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| Cervical adenopathy | General disorders | CTCAE version 5 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE version 5 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE version 5 | Systematic Assessment |
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| Edema face | General disorders | CTCAE version 5 | Systematic Assessment |
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| Facial muscle weakness | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE version 5 | Systematic Assessment |
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| Flu like symptoms | General disorders | CTCAE version 5 | Systematic Assessment |
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| Flushing | Vascular disorders | CTCAE version 5 | Systematic Assessment |
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| Coughing up gastric contents | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Neck stiffness | General disorders | CTCAE version 5 | Systematic Assessment |
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| Cervical lymphadenopathy | General disorders | CTCAE version 5 | Systematic Assessment |
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| Lightheadedness | General disorders | CTCAE version 5 | Systematic Assessment |
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| Hallucinations | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE version 5 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | CTCAE version 5 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | CTCAE version 5 | Systematic Assessment |
|
| Jaw infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
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| BUN Increased | Investigations | CTCAE version 5 | Systematic Assessment |
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| Localized edema | General disorders | CTCAE version 5 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
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| Appetite change | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Right jaw cramps | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Difficulty Chewing | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Neck stiffness | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Neck edema | General disorders | CTCAE version 5 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Pain | General disorders | CTCAE version 5 | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE version 5 | Systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
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| Difficulty urinating | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
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| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Pendunculated lesion | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
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| Teeth extractions | Surgical and medical procedures | CTCAE version 5 | Systematic Assessment |
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| Thrush | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Thyroid stimulating hormone increased | Investigations | CTCAE version 5 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE version 5 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
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