Cervical CancerPhase 2NCT03527264
BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer
A Phase 2 study testing Nivolumab induction, Cisplatin and Radiation in people with Cervical Cancer, run by Brown University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Nivolumab induction, Cisplatin and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2018to 13 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
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
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
- Being tested
- Nivolumab induction, Cisplatin, Radiation, Nivolumab with chemoradiation, Nivolumab maintenance
- Keywords
- cervical cancer, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IVA
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab inductionDrug
2 doses Nivolumab 240mg IV
CisplatinDrug
40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.
RadiationRadiation
Total dose of 45 Gy in 25 fractions at 180 cGy/fx
Whole pelvic or extended field
Nivolumab with chemoradiationDrug
Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
Nivolumab maintenanceDrug
Nivolumab 480 mg IV every 4 weeks for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | Nivolumab during Chemo/RT with whole pelvic RT Receives: Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab with chemoradiation |
| Cohort 1B | Experimental | Nivolumab during Chemo/RT with extended field Receives: Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab with chemoradiation |
| Cohort 2 | Experimental | Chemoradiation followed by Nivolumab Maintenance Receives: Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab maintenance |
| Cohort 3 | Experimental | Nivolumab during chemoradiation and then as maintenance Receives: Drug: Nivolumab induction; Drug: Cisplatin; Radiation: Radiation; Drug: Nivolumab with chemoradiation; Drug: Nivolumab maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Number of patients that are alive without disease progression at time of analysis.
Measured: From start of study treatment through date of study completion, an average of 2 years.
Secondary outcomes (1)
Recurrence Patterns
Determination of the site of recurrence, loco-regional versus distant
Measured: From start of study treatment through date of study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start8 Nov 2018
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Don Dizon, MD, Principal investigator, Brown University Oncology Research Group (BrUOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527264
- Sponsor's protocol ID
- BrUOG 355
- Status last verified
- Mar 2025
- First submitted
- 4 May 2018
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03527264
- Acronym / sponsor ID
- BrUOG 355
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IVA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island, Bristol-Myers Squibb
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 26 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: Nivolumab induction, Drug: Cisplatin, Radiation: Radiation, Drug: Nivolumab with chemoradiationNivolumab during Chemo/RT with whole pelvic RT |
| Cohort 1B | Experimental | Drug: Nivolumab induction, Drug: Cisplatin, Radiation: Radiation, Drug: Nivolumab with chemoradiationNivolumab during Chemo/RT with extended field |
| Cohort 2 | Experimental | Drug: Nivolumab induction, Drug: Cisplatin, Radiation: Radiation, Drug: Nivolumab maintenanceChemoradiation followed by Nivolumab Maintenance |
| Cohort 3 | Experimental | Drug: Nivolumab induction, Drug: Cisplatin, Radiation: Radiation, Drug: Nivolumab with chemoradiation, Drug: Nivolumab maintenanceNivolumab during chemoradiation and then as maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Neuropathy (sensory and motor) ≤ CTCAE v4.0 grade 1
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab induction2 doses Nivolumab 240mg IV | Drug | Cohort 1A, Cohort 1B, Cohort 2, Cohort 3 |
| Cisplatin40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. | Drug | Cohort 1A, Cohort 1B, Cohort 2, Cohort 3 |
| RadiationTotal dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field | Radiation | Cohort 1A, Cohort 1B, Cohort 2, Cohort 3 |
| Nivolumab with chemoradiationNivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. | Drug | Cohort 1A, Cohort 1B, Cohort 3 |
| Nivolumab maintenanceNivolumab 480 mg IV every 4 weeks for 2 years | Drug | Cohort 2, Cohort 3 |
Primary outcome
Progression Free Survival
Time frame: From start of study treatment through date of study completion, an average of 2 years.
Number of patients that are alive without disease progression at time of analysis.
1 secondary outcome
Recurrence Patterns
Time frame: From start of study treatment through date of study completion, an average of 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Dizon, MD principal investigator
Brown University Oncology Research Group (BrUOG)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab induction, Cisplatin and Radiation in people with Cervical Cancer, run by Brown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From start of study treatment through date of study completion, an average of 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.