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

Cervical Cancer Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03527264
• Other study ID #: BrUOG 355
• Status: Terminated
• Phase: Phase 2
• Start date: November 8, 2018
• Est. completion date: November 13, 2020

Study information

• Verified date: March 2022
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 13, 2020
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Nivolumab induction
2 doses Nivolumab 240mg IV
• 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.
• Nivolumab maintenance
Nivolumab 480 mg IV every 4 weeks for 2 years

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
Brown University	Bristol-Myers Squibb, Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Number of patients that are alive without disease progression at time of analysis.	From start of study treatment through date of study completion.
Secondary	Recurrence Patterns	Determination of the site of recurrence, loco-regional versus distant	From start of study treatment through date of study completion.