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

NCT03527264 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: BrUOG 355
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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, an average of 2 years.

Secondary Outcomes (1)

• Recurrence Patterns

  From start of study treatment through date of study completion, an average of 2 years.

Study Arms (4)

Cohort 1A

EXPERIMENTAL

Nivolumab during Chemo/RT with whole pelvic RT

Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab with chemoradiation

Cohort 1B

EXPERIMENTAL

Nivolumab during Chemo/RT with extended field

Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab with chemoradiation

Cohort 2

EXPERIMENTAL

Chemoradiation followed by Nivolumab Maintenance

Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab maintenance

Cohort 3

EXPERIMENTAL

Nivolumab during chemoradiation and then as maintenance

Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab with chemoradiation; Drug: Nivolumab maintenance

Interventions

Nivolumab induction DRUG

2 doses Nivolumab 240mg IV

Cohort 1A; Cohort 1B; Cohort 2; Cohort 3

Cisplatin DRUG

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

Cohort 1A; Cohort 1B; Cohort 2; Cohort 3

Radiation RADIATION

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

Cohort 1A; Cohort 1B; Cohort 2; Cohort 3

Nivolumab with chemoradiation DRUG

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

Cohort 1A; Cohort 1B; Cohort 3

Nivolumab maintenance DRUG

Nivolumab 480 mg IV every 4 weeks for 2 years

Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is for patients with cervical cancer, therefore all patients must be female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Radiation; Nivolumab; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Results Point of Contact

• Title: Don S. Dizon, MD
• Organization: Brown Oncology Research Group

BrUOG@Brown.edu

4018633000

Study Officials

• Don Dizon, MD

  Brown University Oncology Research Group (BrUOG)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 17, 2018
• Study Start: November 8, 2018
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: April 4, 2025
• Results First Posted: April 26, 2022

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)