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

Primary Purpose

Cervical Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nivolumab induction

Cisplatin

Radiation

Nivolumab with chemoradiation

Nivolumab maintenance

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IVA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Rhode Island Hospital
Women and Infants Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1A

Cohort 1B

Cohort 2

Cohort 3

Arm Description

Nivolumab during Chemo/RT with whole pelvic RT

Nivolumab during Chemo/RT with extended field

Chemoradiation followed by Nivolumab Maintenance

Nivolumab during chemoradiation and then as maintenance

Outcomes

Primary Outcome Measures

Progression Free Survival

Number of patients that are alive without disease progression at time of analysis.

Secondary Outcome Measures

Recurrence Patterns

Determination of the site of recurrence, loco-regional versus distant

Full Information

NCT ID

NCT03527264

First Posted

May 4, 2018

Last Updated

March 30, 2022

Sponsor

Brown University

Collaborators

Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island, Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03527264

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment

Study Start Date

November 8, 2018 (Actual)

Primary Completion Date

November 13, 2020 (Actual)

Study Completion Date

November 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brown University

Collaborators

Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island, Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1A

Arm Type

Experimental

Arm Description

Nivolumab during Chemo/RT with whole pelvic RT

Arm Title

Cohort 1B

Arm Type

Experimental

Arm Description

Nivolumab during Chemo/RT with extended field

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Chemoradiation followed by Nivolumab Maintenance

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Nivolumab during chemoradiation and then as maintenance

Intervention Type

Drug

Intervention Name(s)

Nivolumab induction

Intervention Description

2 doses Nivolumab 240mg IV

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field

Intervention Type

Drug

Intervention Name(s)

Nivolumab with chemoradiation

Intervention Description

Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.

Intervention Type

Drug

Intervention Name(s)

Nivolumab maintenance

Intervention Description

Nivolumab 480 mg IV every 4 weeks for 2 years

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

Number of patients that are alive without disease progression at time of analysis.

Time Frame

From start of study treatment through date of study completion.

Secondary Outcome Measure Information:

Title

Recurrence Patterns

Description

Determination of the site of recurrence, loco-regional versus distant

Time Frame

From start of study treatment through date of study completion.

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

This study is for patients with cervical cancer, therefore all patients must be female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Don Dizon, MD

Organizational Affiliation

Brown University Oncology Research Group (BrUOG)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Women and Infants Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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