Clinical trial NCT03527264: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: cervical cancer
Stage IB
Stage IIA
Stage IIB
Stage IIIA
Stage IIIB
Stage IVA
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: The Miriam Hospital
name: Women and Infants Hospital of Rhode Island
name: Bristol-Myers Squibb
First posted: 2018-05-17
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Progression Free Survival
timeFrame: From start of study treatment through date of study completion, an average of 2 years.
Secondary outcomes:
measure: Recurrence Patterns
timeFrame: From start of study treatment through date of study completion, an average of 2 years.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Brown University Oncology Research Group (BrUOG)
name: Don Dizon, MD
role: PRINCIPAL_INVESTIGATOR
References: