Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
Active, enrolledPhase 2Results postedLast updated 8 September 2025
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Cervical Adenocarcinoma in 26 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, female only, with Cervical Adenocarcinoma or Cervical Adenosquamous Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Tumor Response as Assessed by RECIST 1.1 CriteriaPrimary· The average of study treatment time was 3.8 months.
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1.
Group
Value
95% CI
Treatment (Nivolumab)
4
0.9 – 100
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4Primary· Within 100 days of last protocol treatment
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Leukopenia
Group
Value
95% CI
Treatment (Nivolumab)
1
Thrombocytopenia
Group
Value
95% CI
Treatment (Nivolumab)
1
Neutropenia
Group
Value
95% CI
Treatment (Nivolumab)
1
Anemia
Group
Value
95% CI
Treatment (Nivolumab)
3
Other Investigations
Group
Value
95% CI
Treatment (Nivolumab)
4
Endocrine Disorders
Group
Value
95% CI
Treatment (Nivolumab)
1
Gastrointestinal disorders
Group
Value
95% CI
Treatment (Nivolumab)
5
General disorders & administration site conditions
Group
Value
95% CI
Treatment (Nivolumab)
1
Progression-free SurvivalSecondary· Time from study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up.
Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1.
Group
Value
95% CI
Treatment (Nivolumab)
3.5
1.9 – 5.1
Overall SurvivalSecondary· Time from study entry to time of death or the date of last contact, up to 5 years of follow-up
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Group
Value
95% CI
Treatment (Nivolumab)
14.5
8.3 – 26.8
Adverse events — posted to ClinicalTrials.gov
Time frame: All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Nivolumab)
Serious: 12/25 (48%)
Deaths: 19/25
Serious adverse events (13 terms)
Reaction
System
Treatment (Nivolumab)
Abdominal Pain
Gastrointestinal disorders
—
Tumor Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Hypothyroidism
Endocrine disorders
—
Colonic Obstruction
Gastrointestinal disorders
—
Colitis
Gastrointestinal disorders
—
Bile Duct Stenosis
Hepatobiliary disorders
—
Kidney Infection
Infections and infestations
—
Serum Amylase Increased
Investigations
—
Alanine Aminotransferase Increased
Investigations
—
Dehydration
Metabolism and nutrition disorders
—
Vaginal Hemorrhage
Reproductive system and breast disorders
—
Pelvic Pain
Reproductive system and breast disorders
—
Thromboembolic Event
Vascular disorders
—
Other adverse events (109 terms — click to expand)
This phase II trial studies the side effects and how well nivolumab works in treating patients with cervical cancer that has grown, come back, or spread to other places in the body. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 8 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02257528.