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

Conditions:Cervical Cancer, Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Age Range:18 - Any
Start Date:November 8, 2018
End Date:December 2023
Contact:Kayla Rosati, EdM

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BrUOG 355: A Pilot Feasibility Study Incorporating Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer

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

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)

- 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
We found this trial at
Providence, Rhode Island 02905
Phone: 401-863-3000
Providence, RI
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593 Eddy Street
Providence, Rhode Island 02903
Principal Investigator: Don Dizon, MD
Phone: 401-863-3000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
Providence, RI
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