Recurrent or Metastatic Cervical Cancer
Conditions
Keywords
Metastatic Cervical Cancer, MRG003, QL1706, Second-Line or Later Treatment
Brief summary
This is a single-arm, multicenter, phase II study designed to evaluate the efficacy and safety of MRG003, an anti-EGFR antibody-drug conjugate, in combination with QL1706, a PD-1/CTLA-4 bispecific antibody, in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based therapy.
Detailed description
Patients with recurrent or metastatic cervical cancer who have progressed after at least one line of platinum-based chemotherapy will receive:
Interventions
DRUGTreatment
MRG003 \[Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)\]: 2.0 mg/kg IV infusion, Day 1, every 3 weeks QL1706 \[Iparomlimab and tuvonralimab, a bifunctional anti-programmed death-1/cytotoxic T-lymphocyte antigen-4 antibody\]: 5 mg/kg IV infusion, Day 1, every 3 weeks Each treatment cycle is 21 days. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or death.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥18 years Histologically confirmed recurrent or metastatic cervical cancer (squamous, adenocarcinoma, or adenosquamous) Progression after ≥1 line of platinum-based therapy At least one measurable lesion per RECIST v1.1 ECOG performance status 0-1 Life expectancy ≥12 weeks Adequate organ function Recovery from prior treatment toxicities (≤ Grade 1) Agreement to use effective contraception Signed informed consent
Exclusion criteria
Active malignancy within 5 years (except certain cured cancers) Active CNS metastases Significant cardiovascular disease Uncontrolled comorbidities Active hepatitis B/C or uncontrolled HIV infection Interstitial lung disease or pneumonitis Prior EGFR-targeted therapy Prior T-cell co-stimulatory pathway agents Recent live vaccination Use of strong CYP3A4 inhibitors/inducers Pregnancy or breastfeeding Any condition deemed unsuitable by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 24 months | Proportion of patients achieving CR or PR per RECIST v1.1 |
Outcome results
None listed