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Study of Cemiplimab in Adults With Cervical Cancer
Phase 3 trial testing Cemiplimab in Squamous Cell Carcinoma (SCC) in 608 participants. Completed in 20 April 2023.
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 608 |
| Start date | 5 September 2017 |
| Primary completion | 15 March 2021 |
| Estimated completion | 20 April 2023 |
| Sites | 105 locations across Italy, Japan, Russia, Greece, Belgium, Taiwan, United Kingdom, Poland |
Regeneron Pharmaceuticals — full company profile →
18 and older, female only, with Squamous Cell Carcinoma (SCC) or Recurrent or Metastatic, Platinum-refractory 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.
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.
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 11.7 | 9.6 – 13.4 |
| Investigator Choice (IC) Chemotherapy | 8.5 | 7.5 – 9.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 2.8 | 2.6 – 3.9 |
| Investigator Choice (IC) Chemotherapy | 2.9 | 2.7 – 3.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 52 | |
| Investigator Choice (IC) Chemotherapy | 19 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 18.7 | 16.4 – NA |
| Investigator Choice (IC) Chemotherapy | 7.2 | 5.1 – 9.9 |
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
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 0.46 | -2.715 – 3.642 |
| Investigator Choice (IC) Chemotherapy | -8.54 | -13.004 – -4.084 |
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | -0.27 | -3.014 – 2.473 |
| Investigator Choice (IC) Chemotherapy | -8.86 | -12.517 – -5.196 |
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 initi
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 269 | |
| Investigator Choice (IC) Chemotherapy | 266 |
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 96 | |
| Investigator Choice (IC) Chemotherapy | 78 |
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 5 | |
| Investigator Choice (IC) Chemotherapy | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 84 | |
| Investigator Choice (IC) Chemotherapy | 137 |
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 47 | |
| Investigator Choice (IC) Chemotherapy | 32 |
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 12 | |
| Investigator Choice (IC) Chemotherapy | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 28 | |
| Investigator Choice (IC) Chemotherapy | 23 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cemiplimab | 10.9 | 8.9 – 12.9 |
| Investigator Choice (IC) Chemotherapy | 8.8 | 7.6 – 9.8 |
Time frame: From first dose up to 90 following last dose (~42 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cemiplimab | Chemotherapy* | Chemotherapy to Cemiplimab* |
|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Pyelonephritis | Infections and infestations | — | — | — |
| Autoimmune hepatitis | Hepatobiliary disorders | — | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — |
| Hydronephrosis | Renal and urinary disorders | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| Immune-mediated hepatitis | Hepatobiliary disorders | — | — | — |
| Cellulitis | Infections and infestations | — | — | — |
| Pyelonephritis acute | Infections and infestations | — | — | — |
| Pelvic abscess | Infections and infestations | — | — | — |
| Kidney infection | Infections and infestations | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Ileus | Gastrointestinal disorders | — | — | — |
| Reaction | System | Cemiplimab | Chemotherapy* | Chemotherapy to Cemiplimab* |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Asthenia | General disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Pelvic pain | Reproductive system and breast disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Vaginal haemorrhage | Reproductive system and breast disorders | — | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — | — |
| Hyperthyroidism | Endocrine disorders | — | — | — |
| Subcutaneous abscess | Infections and infestations | — | — | — |
Most-reported serious reactions: Urinary tract infection, Anaemia, Febrile neutropenia, Pyrexia, Pneumonia, Acute kidney injury, Pyelonephritis, Autoimmune hepatitis.
Data from ClinicalTrials.gov NCT03257267 adverse events section.
The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
8 peer-reviewed publications reference this trial (live from Europe PMC):
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