Clinical Trials /

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

NCT03527264

Description:

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

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: BrUOG 355
  • NCT ID: NCT03527264

Conditions

  • Cervical Cancer

Interventions

DrugSynonymsArms
Nivolumab inductionCohort 1A
CisplatinCohort 1A
Nivolumab with chemoradiationCohort 1A
Nivolumab maintenanceCohort 2

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Cohort 1AExperimentalNivolumab during Chemo/RT with whole pelvic RT
  • Nivolumab induction
  • Cisplatin
  • Nivolumab with chemoradiation
Cohort 1BExperimentalNivolumab during Chemo/RT with extended field
  • Nivolumab induction
  • Cisplatin
  • Nivolumab with chemoradiation
Cohort 2ExperimentalChemoradiation followed by Nivolumab Maintenance
  • Nivolumab induction
  • Cisplatin
  • Nivolumab maintenance
Cohort 3ExperimentalNivolumab during chemoradiation and then as maintenance
  • Nivolumab induction
  • Cisplatin
  • Nivolumab with chemoradiation
  • Nivolumab maintenance

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Don Dizon

Trial Keywords

  • cervical cancer
  • Stage IB
  • Stage IIA
  • Stage IIB
  • Stage IIIA
  • Stage IIIB
  • Stage IVA

Last Updated