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Slow enrollment
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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
| The Miriam Hospital | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
| Bristol-Myers Squibb |
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This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of the investigational drug in combination with radiation to learn whether the drug(s) works in treating a specific disease. In this study, researchers are studying three treatment arms, each using standard chemotherapy, with the drug cisplatin and radiation and the drug Nivolumab. Each treatment Arm will test the addition of Nivolumab at a different time point
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A | Experimental | Nivolumab during Chemo/RT with whole pelvic RT |
|
| Cohort 1B | Experimental | Nivolumab during Chemo/RT with extended field |
|
| Cohort 2 | Experimental | Chemoradiation followed by Nivolumab Maintenance |
|
| Cohort 3 | Experimental | Nivolumab during chemoradiation and then as maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab induction | Drug | 2 doses Nivolumab 240mg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Number of patients that are alive without disease progression at time of analysis. | From start of study treatment through date of study completion, an average of 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Patterns | Determination of the site of recurrence, loco-regional versus distant | From start of study treatment through date of study completion, an average of 2 years. |
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Inclusion Criteria:
Age ≥ 18 years.
ECOG performance status ≤2
Patients with histologically confirmed advanced cervical cancer (any cell type): FIGO Clinical stages IB, IIA, IIB, IIIA, IIIB, IVA.
Participants must have normal organ and marrow function as defined below:
Neuropathy (sensory and motor) ≤ CTCAE v4.0 grade 1
Patients with ureteral obstruction should undergo stent or nephrostomy tube placement prior to study entry. Any side effects or complications associated with stent placement that, in the opinion of the treating investigator, puts the patient at increased risk for treatment-related toxicity, must be resolved completely prior to study enrollment.
Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry (within 7 days prior to initiation of study treatment) and be practicing an effective form of contraception during study treatment and for 24 months (2 years) thereafter.
Women should not breast-feed while on this study
Patients must not be receiving any other investigational agent
Ability to understand and the willingness to sign a written informed consent document.
All patients with a history of hearing loss are required to have an audiogram within 28 days prior to initiating protocol therapy. If patient does not have a history of hearing loss this must be documented by treating physician.
Exclusion Criteria:
This study is for patients with cervical cancer, therefore all patients must be female
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| Name | Affiliation | Role |
|---|---|---|
| Don Dizon, MD | Brown University Oncology Research Group (BrUOG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States | ||
| Women and Infants Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1A | Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. |
| 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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 11, 2020 |
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| INDUSTRY |
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| Cisplatin | Drug | 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. |
|
| Radiation | Radiation | Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field |
|
| Nivolumab with chemoradiation | Drug | Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. |
|
| Nivolumab maintenance | Drug | Nivolumab 480 mg IV every 4 weeks for 2 years |
|
| Providence |
| Rhode Island |
| 02905 |
| United States |
| FG001 | Cohort 1B | Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. |
| FG002 | Cohort 2 | Chemoradiation followed by Nivolumab Maintenance Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years |
| FG003 | Cohort 3 | Nivolumab during chemoradiation and then as maintenance Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
Study was terminated prior to enrolling patients in cohort 2 & cohort 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1A | Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. |
| BG001 | Cohort 1B | Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. |
| BG002 | Cohort 2 | Chemoradiation followed by Nivolumab Maintenance Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years |
| BG003 | Cohort 3 | Nivolumab during chemoradiation and then as maintenance Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years |
| BG004 | 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 | Full Range | 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 | Number | 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 | Progression Free Survival | Number of patients that are alive without disease progression at time of analysis. | Posted | Count of Participants | Participants | From start of study treatment through date of study completion, an average of 2 years. |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Recurrence Patterns | Determination of the site of recurrence, loco-regional versus distant | Only 1 patient on cohort 1A had recurrence within 3 years of study entry. | Posted | Count of Participants | Participants | From start of study treatment through date of study completion, an average of 2 years. |
|
All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
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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 | Cohort 1A | Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Cohort 1B | Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| GERD | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Serum creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Don S. Dizon, MD | Brown Oncology Research Group | 4018633000 | BrUOG@Brown.edu |
| Feb 28, 2022 |
| Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D011827 | Radiation |
| D000077594 | Nivolumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D055585 | Physical Phenomena |
| 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 |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| >=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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|