Clinical trial · Interventional
JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer
A Randomized, Controlled, Open-Label, Multi-center, Phase III Study 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine (GEM) | Drug | Gemcitabine | ALIAS |
| JSKN033 | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- JSKN033
- interventionNames
- Drug: JSKN033
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator
- description
- Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
- interventionNames
- Drug: Docetaxel
- Drug: Topotecan
- Drug: Gemcitabine (GEM)
- Drug: Pemetrexed
Primary outcomes (2)
- measure
- Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available