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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 : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : April 6, 2021
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

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE November 8, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • 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.
  • 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.
  • Progression free survival [ Time Frame: Through 3 years post study treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer
Official Title  ICMJE BrUOG 355: A Pilot Feasibility Study Incorporating Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1A
    Nivolumab during Chemo/RT with whole pelvic RT
    Interventions:
    • Drug: Nivolumab induction
    • Drug: Cisplatin
    • Radiation: Radiation
    • Drug: Nivolumab with chemoradiation
  • Experimental: Cohort 1B
    Nivolumab during Chemo/RT with extended field
    Interventions:
    • Drug: Nivolumab induction
    • Drug: Cisplatin
    • Radiation: Radiation
    • Drug: Nivolumab with chemoradiation
  • Experimental: Cohort 2
    Chemoradiation followed by Nivolumab Maintenance
    Interventions:
    • Drug: Nivolumab induction
    • Drug: Cisplatin
    • Radiation: Radiation
    • Drug: Nivolumab maintenance
  • Experimental: Cohort 3
    Nivolumab during chemoradiation and then as maintenance
    Interventions:
    • Drug: Nivolumab induction
    • Drug: Cisplatin
    • Radiation: Radiation
    • Drug: Nivolumab with chemoradiation
    • Drug: Nivolumab maintenance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 5, 2021)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
24
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527264
Other Study ID Numbers  ICMJE BrUOG 355
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Don Dizon, Brown University
Study Sponsor  ICMJE Don Dizon
Collaborators  ICMJE
  • Rhode Island Hospital
  • The Miriam Hospital
  • Women and Infants Hospital of Rhode Island
  • Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Don Dizon, MD Brown University Oncology Research Group (BrUOG)
PRS Account Brown University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP