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

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Don Dizon
• Collaborators: Bristol-Myers Squibb; Rhode Island Hospital; The Miriam Hospital; Women and Infants Hospital of Rhode Island
• Treatments: Antibodies, Monoclonal; Cisplatin; Nivolumab

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