Recurrent or Metastatic Cervical Cancer
Conditions
Brief summary
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.
Interventions
DRUGJSKN033
JSKN033 should be administered subcutaneously
DRUGDocetaxel
Docetaxel
DRUGTopotecan
Topotecan
Gemcitabine
DRUGPemetrexed
Pemetrexed
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntary participation and written informed consent. * ≥18 years; * ECOG performance status score of 0 or 1. * Expected survival of more than 3 months. * Histologically or cytologically confirmed recurrent or metastatic cervical cancer. * At least one measurable lesion in the baseline. * Adequate organ function. * Provide primary or metastatic tumor samples. * Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.
Exclusion criteria
* Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma. * Other-malignancy diagnosed within 3 years prior to randomization. * Active central nervous system metastases. * Baseline imaging showing tumor invasion, compression of, or arising from vital organs. * Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates. * Inadequate washout from prior therapy before randomization. * Risk factors for ILD. * Significant cardiovascular or cerebrovascular disease. * Clinically-significant gastrointestinal abnormalities. * History of genital-tract fistula. * Uncontrolled pleural effusion. * Active or prior autoimmune-disease . * Uncontrolled infection. * Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1. * History of ≥Grade 3 immune-related adverse events irAEs. * Previous allogeneic bone-marrow or solid organ transplantation. * Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent. * Pregnant or lactating female participants, or women planning pregnancy during the study. * Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 27 months | OS was defined as the time from randomization until the date of death from any cause |
| Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1 | Up to approximately 27 months | PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1 | Up to approximately 27 months | DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first |
| Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1 | Up to approximately 27 months | DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD) |
| PFS evaluated by the Investigator as per RECIST 1.1 | Up to approximately 27 months | PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first |
| ORR evaluated by the Investigator as per RECIST 1.1 | Up to approximately 27 months | ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) |
| DoR evaluated by the Investigator as per RECIST 1.1 | Up to approximately 27 months | DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first |
| DCR evaluated by the Investigator as per RECIST 1.1 | Up to approximately 27 months | DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD) |
| Number and Severity of Treatment-emergent Adverse Events (TEAEs) | Up to approximately 27 months | The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc. |
| Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24) | Up to approximately 27 months | Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24). All scores are transformed to a 0-100 scale; higher scores indicate worse outcomes for symptom scales, except for sexual activity and sexual enjoyment items where higher scores indicate better outcomes. |
| Plasma Concentrations of JSKN003 | Up to approximately 27 months | Measurement of plasma concentrations of JSKN003. |
| Plasma Concentration of Total Antibody | Up to approximately 27 months | Measurement of plasma concentration of total antibody. |
| Plasma Concentration of Free Payload | Up to approximately 27 months | Measurement of plasma concentration of free payload. |
| Plasma Concentration of Envotumab | Up to approximately 27 months | Measurement of plasma concentration of envotumab. |
| Incidence and Titer of Anti-Drug Antibodies | Up to approximately 27 months | Assessment of the incidence and titer of anti-drug antibodies, as applicable. |
| Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Up to approximately 27 months | Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). All scores are transformed to a 0-100 scale. Higher scores represent better function/global quality-of-life status for functional and global health scales, and worse symptom burden for symptom scales. |
| Incidence and Titer of Neutralizing Antibodies | Up to approximately 27 months | Assessment of the incidence and titer of neutralizing antibodies, as applicable. |
| Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1 | Up to approximately 27 months | ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) |
Countries
China
Contacts
CONTACTXiaohua Wu, Doctor
Outcome results
None listed