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BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer

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ClinicalTrials.gov Identifier: NCT03527264
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Women and Infants Hospital of Rhode Island
Bristol-Myers Squibb
Information provided by (Responsible Party):
Don Dizon, Brown University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Nivolumab induction Drug: Cisplatin Radiation: Radiation Drug: Nivolumab with chemoradiation Drug: Nivolumab maintenance Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BrUOG 355: A Pilot Feasibility Study Incorporating Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Cohort 1A
Nivolumab during Chemo/RT with whole pelvic RT
Drug: Nivolumab induction
2 doses Nivolumab 240mg IV

Drug: Cisplatin
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


Drug: Nivolumab with chemoradiation
Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.

Experimental: Cohort 1B
Nivolumab during Chemo/RT with extended field
Drug: Nivolumab induction
2 doses Nivolumab 240mg IV

Drug: Cisplatin
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


Drug: Nivolumab with chemoradiation
Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.

Experimental: Cohort 2
Chemoradiation followed by Nivolumab Maintenance
Drug: Nivolumab induction
2 doses Nivolumab 240mg IV

Drug: Cisplatin
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


Drug: Nivolumab maintenance
Nivolumab 480 mg IV every 4 weeks for 2 years

Experimental: Cohort 3
Nivolumab during chemoradiation and then as maintenance
Drug: Nivolumab induction
2 doses Nivolumab 240mg IV

Drug: Cisplatin
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


Drug: Nivolumab with chemoradiation
Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.

Drug: Nivolumab maintenance
Nivolumab 480 mg IV every 4 weeks for 2 years




Primary Outcome Measures :
  1. Feasibility of the incorporation of nivolumab with weekly cisplatin and extended field (EFRT) or whole pelvic radiation therapy (WPRT) in women with cervical cancer. [ Time Frame: Treatment time period, which may be up to approximately 7 months ]
    Acute Treatment-related toxicities that occur during and within six months of study treatment will be summarized by maximum grade and by term using CTCAE v4.0. Acute toxicities will be used to determine the feasibility within each cohort.

  2. Feasibility of the regimen through assessment of acute toxicities. [ Time Frame: 30 days post treatment ]
    Acute Treatment-related toxicities that occur during and within six months of study treatment will be summarized by maximum grade and by term using CTCAE v4.0. Acute toxicities will be used to determine the feasibility within each cohort.

  3. Progression free survival [ Time Frame: Through 3 years post study treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is for patients with cervical cancer, therefore all patients must be female
Accepts Healthy Volunteers:   No
Criteria

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:

    1. absolute neutrophil count ≥1,500/mcL
    2. platelets ≥100,000/mcL
    3. total bilirubin within normal institutional limits
    4. AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
    5. creatinine Within normal institutional limits
  • 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:

  • Participants with visceral metastases, including brain metastases.
  • Uncontrolled intercurrent illness
  • Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy
  • Patients who have circumstances that will not permit completion of this study or the required follow-up as per the treating physician
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years (2 years for invasive breast cancer). However, patients with a malignancy that is non-likely to require treatment, as per the treating physician, in the next 2 years, such as a completely resected, early stage breast cancer, are eligible. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Prior treatment with immunotherapy for any cancer, including immune checkpoint inhibitors or anti-CTLA4 agents
  • Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields as documented by treating physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527264


Contacts
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Contact: Roxanne Wood, BA 4018633000 Roxanne_Wood@brown.edu

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Roxanne Wood, BA    401-863-3000    Roxanne_Wood@brown.edu   
Contact: Amy Webber, BA    4018633000    Amy_Webber@brown.edu   
Principal Investigator: Don Dizon, MD         
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Roxanne Wood, BA    401-863-3000    Roxanne_Wood@brown.edu   
Contact: Amy Webber, BA    4018633000    Amy_Webber@brown.edu   
Principal Investigator: Cara Mathews, MD         
Sponsors and Collaborators
Don Dizon
Rhode Island Hospital
The Miriam Hospital
Women and Infants Hospital of Rhode Island
Bristol-Myers Squibb
Investigators
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Principal Investigator: Don Dizon, MD Brown University Oncology Research Group (BrUOG)
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Responsible Party: Don Dizon, Principal Investigator: Sponsor-Investigator, Brown University
ClinicalTrials.gov Identifier: NCT03527264    
Other Study ID Numbers: BrUOG 355
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Don Dizon, Brown University:
cervical cancer
Stage IB
Stage IIA
Stage IIB
Stage IIIA
Stage IIIB
Stage IVA
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Nivolumab
Antineoplastic Agents
Antineoplastic Agents, Immunological