ASCERV Study: MRG003 Combined With QL1706 in Recurrent or Metastatic Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment.
- Who it may be relevant to
- Registry conditions: Recurrent or Metastatic Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Multicenter, Phase II Study of MRG003 Combined With QL1706 for Second-Line or Later Treatment of Recurrent or Metastatic Cervical Cancer (ASCERV Study)
Overview
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
- Drug Treatment
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.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: Up to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07542717 · ASCERV Study