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BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer
Phase 2 trial testing Nivolumab induction in Cervical Cancer in 4 participants. Terminated before completion.
| Lead sponsor | Brown University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 8 November 2018 |
| Primary completion | 13 November 2020 |
| Estimated completion | 13 November 2020 |
| Sites | 2 locations across United States |
Brown University
18 and older, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients that are alive without disease progression at time of analysis.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A | 2 | |
| Cohort 1B | 1 |
Determination of the site of recurrence, loco-regional versus distant
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1A | 1 | |
| Cohort 1B | 0 | |
| Cohort 1A | 0 | |
| Cohort 1B | 0 |
Time frame: All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1A | Cohort 1B |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Generalized muscle weakness | General disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Suicidal ideation | Psychiatric disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Reaction | System | Cohort 1A | Cohort 1B |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Fatigue | General disorders | — | — |
| Dizziness | Psychiatric disorders | — | — |
| Weight loss | Investigations | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Chills | General disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Lipase increased | Investigations | — | — |
| Pelvic pain | Reproductive system and breast disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Rectal hemorrhage | Gastrointestinal disorders | — | — |
| Allergic reaction | Immune system disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Hypoalbuminemia | Investigations | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| GERD | Gastrointestinal disorders | — | — |
| Serum amylase increased | Investigations | — | — |
| Serum creatinine increased | Investigations | — | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — | — |
| Fever | General disorders | — | — |
| Cough | General disorders | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Nausea, Vomiting, Fatigue, Generalized muscle weakness, Sepsis, Suicidal ideation, Hypotension.
Data from ClinicalTrials.gov NCT03527264 adverse events section.
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
8 peer-reviewed publications reference this trial (live from Europe PMC):
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