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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This research is being performed to treat patient for head and neck cancer patients who have not received prior chemotherapy.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug or combination of interventions is being studied.
Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or advanced head and neck cancer (head and neck cancer that has come back or is incurable) but is considered investigational for head and neck cancer patients who have not received prior chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) then Radioimmunotherapy (IMRT+N) then adjuvant N | Experimental | Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1. Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses). Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab is a type of immunotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Laryngectomy-free Survival (LFS) | LFS defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, or death due to any cause. Participants alive with intact larynx and hypopharynx are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LFS. | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Radiologic Response | Best radiologic response on treatment was evaluated per RECIST 1.1 criteria. For target lesions: complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Non-CR/Non-PD defined as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. |
Not provided
Inclusion Criteria:
Subject must have histologically or cytologically confirmed, resectable or unresectable, Stage III or Stage IV locoregionally advanced squamous cell carcinoma of the larynx or hypopharynx, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition
Willing to provide tissue from diagnostic biopsy and blood samples before, during, and after treatment
Any smoking history is permitted
Patients must have HPV negative disease. Those patients with a supraglottic primary are required to undergo HPV testing with p16 immunohistochemistry and/or confirmatory HPV PCR or ISH testing to rule out oropharyngeal origin with laryngeal extension
Age 18 years or older
ECOG performance status ≤ 1 (Karnofsky ≥ 80%, see Appendix A)
Participant must have normal organ and marrow function as defined below within 21 days prior to study registration:
Ability to understand and the willingness to sign a written informed consent document
Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception. WOCBP should plan to use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of nivolumab
Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Haddad, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Institute | Atlanta | Georgia | 30308 | United States | ||
| Dana Farber Cancer Institute |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
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Enrollment period: December 19, 2019 to November 3, 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1. Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses). Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2020 |
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| Cisplatin | Drug | Cisplatin is a chemotherapy drug. |
|
|
| Docetaxel | Drug | Docetaxel is a chemotherapy drug. |
|
|
| Intensity-modulated radiotherapy | Radiation | IMRT is definitive treatment for head and neck cancer. |
|
|
| Disease evaluation following the completion of the induction phase of treatment on cycle 3 day 43-63. |
| Median Censoring Time for Overall Survival (OS) | Overall Survival (OS) is defined as the time from study entry to death or censored at date last known alive. Given limited sample size and zero events, the Kaplan-Meier method was not used for the estimate of OS. The empirical median is provided which represents median time to date last known alive (all 6 participants were censored). | Participants were observed for OS up to 23.2 months. |
| Median Laryngo-esophageal Dysfunction-free Survival (LEDFS) | LEDFS is defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, non-functioning larynx and/or hypopharynx (inability to swallow, speak, and/or breath on own), or death from any cause. Participants alive with intact and functioning larynx and hypopharynx and esophagus are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LEDFS. | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were observed for LEDFS up to 18.9 months. |
| EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The emotional functional (EF) scale has 3 items (v3 items 21-24). Scores are standardized to range from 0-100. Higher scores indicate better emotional health. | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. |
| Number of Participants With Grade 3-5 Treatment-related Adverse Events | All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 The number of treated participants experiencing at least one of these adverse events as defined during the time of observation was counted. | AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. |
| EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The fatigue scale has 3 items (v3 items 10,12,18). Scores are standardized to range from 0-100. Higher scores indicate more symptomatology. | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The Tisch Cancer Institute | New York | New York | 10029 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N | Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1. Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses). Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence. |
| 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 |
|
| 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 | Median Laryngectomy-free Survival (LFS) | LFS defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, or death due to any cause. Participants alive with intact larynx and hypopharynx are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LFS. | Posted | Median | Full Range | months | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Best Radiologic Response | Best radiologic response on treatment was evaluated per RECIST 1.1 criteria. For target lesions: complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Non-CR/Non-PD defined as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. | Posted | Count of Participants | Participants | Disease evaluation following the completion of the induction phase of treatment on cycle 3 day 43-63. |
| |||||||||||||||||||||||||||||
| Secondary | Median Censoring Time for Overall Survival (OS) | Overall Survival (OS) is defined as the time from study entry to death or censored at date last known alive. Given limited sample size and zero events, the Kaplan-Meier method was not used for the estimate of OS. The empirical median is provided which represents median time to date last known alive (all 6 participants were censored). | Posted | Median | Full Range | months | Participants were observed for OS up to 23.2 months. |
| ||||||||||||||||||||||||||||
| Secondary | Median Laryngo-esophageal Dysfunction-free Survival (LEDFS) | LEDFS is defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, non-functioning larynx and/or hypopharynx (inability to swallow, speak, and/or breath on own), or death from any cause. Participants alive with intact and functioning larynx and hypopharynx and esophagus are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LEDFS. | Posted | Median | Full Range | months | Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were observed for LEDFS up to 18.9 months. |
| ||||||||||||||||||||||||||||
| Secondary | EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The emotional functional (EF) scale has 3 items (v3 items 21-24). Scores are standardized to range from 0-100. Higher scores indicate better emotional health. | The evaluable population represents participants with the QLQ-C30 completed at both assessment times. | Posted | Median | Full Range | units on a scale | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3-5 Treatment-related Adverse Events | All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 The number of treated participants experiencing at least one of these adverse events as defined during the time of observation was counted. | Posted | Count of Participants | Participants | AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. |
| |||||||||||||||||||||||||||||
| Secondary | EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The fatigue scale has 3 items (v3 items 10,12,18). Scores are standardized to range from 0-100. Higher scores indicate more symptomatology. | The evaluable population represents participants with the QLQ-C30 completed at both assessment times. | Posted | Median | Full Range | units on a scale | At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment. |
|
AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
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 | Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy | Docetaxel will be administered per standard institutional every 3 weeks Nivolumab will be administered intravenously every 3 weeks Cisplatin will be administered intravenously every 3 weeks Radioimmunotherapy will be conducted 3 weeks after the last cycle of TPN (docetaxel, cisplatin and nivolumab) Nivolumab: Nivolumab is a type of immunotherapy that tries to enhance participants own immune system to fight cancer Cisplatin: Cisplatin is a chemotherapy medication used to treat a number of cancers Docetaxel: Docetaxel (Taxotere®) is a chemotherapy drug. It is used to treat many types of cancer including head and neck Radioimmunotherapy: Radiation Therapy to shrink or kill tumors. | 0 | 6 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorders - Other | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
This study terminated early due to weak accrual and therefore no inference is possible.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Haddad, MD | Dana-Farber Cancer Institute | 617.632.3090 | Robert_Haddad@dfci.harvard.edu |
| Sep 12, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|