Trial · NCT03257267
Study of Cemiplimab in Adults With Cervical Cancer
NCT03257267, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2022-04-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Cemiplimab in Adults With Cervical Cancer. Trials, record NCT03257267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03257267
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cemiplimab in Adults With Cervical Cancer
- NCT number
- NCT03257267
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 608 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Squamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer
- Interventions
- Cemiplimab, Investigator Choice (IC) Chemotherapy
- First posted
- 2017-08-22
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2017-000350-19
- Results first posted
- 2022-04-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From first dose up to 90 following last dose (~42 months) | Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact. |
| Primary | Overall Survival (OS) in the SCC Population | From first dose up to 90 following last dose (~42 months) | Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact. |
| Secondary | Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months) | PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who did not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment. |
| Secondary | Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | From date of randomization up to 40 months | ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm) (\<1 centimeter \[cm\]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Response (DOR) Assessed Per RECIST 1.1 | Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months) | DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progressed while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate. |
| Secondary | Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days) | EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | From first dose up to 90 following last dose (~36 months) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A Treatment-emergent adverse event (TEAE) was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported. |
| Secondary | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | From first dose up to 90 following last dose (~36 months) | Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From first dose up to 90 following last dose (~42 months) | The full analysis set (FAS) included all randomized participants. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months) | The FAS included all randomized participants. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | From date of randomization up to 40 months | The FAS included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) Assessed Per RECIST 1.1 | Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months) | The FAS included all randomized participants with confirmed CR or PR. Here 'n' = number of evaluable participants at a specified timeframe. | Months | MEDIAN |
| SECONDARY | Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days) | The FAS included all randomized participants. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | From first dose up to 90 following last dose (~36 months) | The safety analysis set (SAF) included all randomized participants who received any study drug. Here 'n' = number of evaluable participants at a specified timeframe. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | From first dose up to 90 following last dose (~36 months) | The SAF included all randomized participants who received any study drug. Here 'n' = number of evaluable participants at a specified timeframe. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS) in the SCC Population | From first dose up to 90 following last dose (~42 months) | All randomized participants who presented SCC (Squamous cell carcinoma) histology. Here 'n' = the number of evaluable participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Cemiplimab | 11.7 | 95% Confidence Interval 9.6 to 13.4 | Months | |
| Overall Survival (OS) | Investigator Choice (IC) Chemotherapy | 8.5 | 95% Confidence Interval 7.5 to 9.6 | Months | |
| Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Cemiplimab | 2.8 | 95% Confidence Interval 2.6 to 3.9 | Months | |
| Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Investigator Choice (IC) Chemotherapy | 2.9 | 95% Confidence Interval 2.7 to 3.5 | Months | |
| Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | Cemiplimab | 52 | Participants | ||
| Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | Investigator Choice (IC) Chemotherapy | 19 | Participants | ||
| Duration of Response (DOR) Assessed Per RECIST 1.1 | Cemiplimab | 18.7 | 95% Confidence Interval 16.4 to NA | Months | |
| Duration of Response (DOR) Assessed Per RECIST 1.1 | Investigator Choice (IC) Chemotherapy | 7.2 | 95% Confidence Interval 5.1 to 9.9 | Months | |
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Cemiplimab | Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL | 0.46 | 95% Confidence Interval -2.715 to 3.642 | Score on a Scale |
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Investigator Choice (IC) Chemotherapy | Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL | -8.54 | 95% Confidence Interval -13.004 to -4.084 | Score on a Scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cemiplimab | 304 | |
| Overall Study | STARTED | Investigator Choice (IC) Chemotherapy | 304 | |
| Overall Study | Full Analysis Set (FAS) | Cemiplimab | 304 | |
| Overall Study | Full Analysis Set (FAS) | Investigator Choice (IC) Chemotherapy | 304 | |
| Overall Study | Safety Analysis Set (SAF) | Cemiplimab | 300 | |
| Overall Study | Safety Analysis Set (SAF) | Investigator Choice (IC) Chemotherapy | 290 | |
| Overall Study | Completed Treatment | Cemiplimab | 38 | |
| Overall Study | Completed Treatment | Investigator Choice (IC) Chemotherapy | 0 | |
| Overall Study | COMPLETED | Cemiplimab | 35 | |
| Overall Study | COMPLETED | Investigator Choice (IC) Chemotherapy | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events555
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Cemiplimab | 63 | 300 | 74 |
| other | Nausea | Gastrointestinal disorders | Chemotherapy* | 100 | 290 | 175 |
| other | Nausea | Gastrointestinal disorders | Chemotherapy to Cemiplimab* | 0 | 8 | 0 |
| other | Vomiting | Gastrointestinal disorders | Cemiplimab | 49 | 300 | 65 |
| other | Vomiting | Gastrointestinal disorders | Chemotherapy* | 66 | 290 | 101 |
| other | Vomiting | Gastrointestinal disorders | Chemotherapy to Cemiplimab* | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Cemiplimab | 46 | 300 | 50 |
| other | Constipation | Gastrointestinal disorders | Chemotherapy* | 58 | 290 | 64 |
| other | Constipation | Gastrointestinal disorders | Chemotherapy to Cemiplimab* | 1 | 8 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Cemiplimab | 35 | 300 | 61 |
1 to 10 of 555Source ClinicalTrials.gov
See all 555 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cemiplimab | 234 | 300 |
| Total, all-cause mortality | Chemotherapy* | 249 | 290 |
| Total, all-cause mortality | Chemotherapy to Cemiplimab* | 2 | 8 |
| Total, other adverse events | Cemiplimab | 239 | 300 |
| Total, other adverse events | Chemotherapy* | 253 | 290 |
| Total, other adverse events | Chemotherapy to Cemiplimab* | 4 | 8 |
| Total, serious adverse events | Cemiplimab | 100 | 300 |
| Total, serious adverse events | Chemotherapy* | 84 | 290 |
| Total, serious adverse events | Chemotherapy to Cemiplimab* | 1 | 8 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cemiplimab vs Investigator Choice (IC) Chemotherapy: Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03257267
GET https://conductscience.org/api/trials/v1/NCT03257267/results?page=2