Iparomlimab/Tuvonralimab with concurrent chemoradiation for locally advanced cervical cancer
A Clinical Study to Evaluate the Safety and Efficacy of Iparomlimab/Tuvonralimab Injection (QL1706, a Bifunctional Mabpair Product of Anti-PD-1 and Anti-CTLA-4 Antibodies) in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
This trial will test whether adding QL1706 (iparomlimab/tuvonralimab), a combined anti‑PD‑1/anti‑CTLA‑4 antibody pair, to standard concurrent cisplatin chemoradiation is safe and helpful for people with HPV‑related locally advanced cervical cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy, prednisone, Iparomlimab, Tuvonralimab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07232654 on ClinicalTrials.gov |
What this trial studies
This is a phase 2 interventional trial that gives QL1706 (a bifunctional anti‑PD‑1/CTLA‑4 antibody pair) alongside standard concurrent chemoradiation (weekly cisplatin, external beam radiotherapy, and brachytherapy) to patients with FIGO 2018 stage III–IVA, node‑positive, non‑metastatic cervical cancer. The protocol enrolls adult women with ECOG 0–1, histologically confirmed HPV‑related squamous, adenocarcinoma, or adenosquamous carcinoma, and at least one measurable lesion per RECIST 1.1. Key safety and efficacy endpoints include treatment tolerability and tumor response/clinical outcomes during and after combined therapy. Participants must have adequate organ function and be able to receive all treatments and follow‑up at the participating center in Beijing.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–75 with HPV‑related locally advanced (FIGO III–IVA), node‑positive, non‑metastatic cervical cancer, ECOG 0–1, measurable disease per RECIST 1.1, and adequate organ function.
Not a fit: Patients with distant metastatic disease (M1), poor performance status (ECOG >1), inadequate organ function, non‑HPV histology, or who cannot receive radiotherapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding this dual immune checkpoint approach to standard chemoradiation could improve tumor control and potentially increase survival for patients with locally advanced cervical cancer.
How similar studies have performed: Single‑agent PD‑1 inhibitors have shown benefit in recurrent/metastatic cervical cancer and combining immunotherapy with chemoradiation is an active area of research, while bifunctional anti‑PD‑1/CTLA‑4 therapies in this setting are relatively novel and less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Informed consent. * Female patients aged ≥18 years and ≤ 75 years at time of inform consent signature * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Expected survival ≥ 3 months * Patients must have histologically confirmed diagnosis of HPV-related cervical squamous, or adenocarcinoma, or adenosquamous carcinoma * FIGO 2018 stage T3a-4a (III-IVA), N1 (positive lymph node metastasis on CT/MRI with short-axis ≥1 cm, or PET-CT showing one or more lymph node metastases with SUVmax ≥2.5), M0 * Has at least one evaluable disease per RECIST 1.1 * Has adequate organ function * Hematology: ANC ≥1.5 ×10⁹/L; platelets ≥100 ×10⁹/L; hemoglobin ≥90 g/L (no blood transfusion or growth factor support within 7 days) * Renal: CrCl ≥50 mL/min (Cockcroft-Gault formula), urine protein \<2+ or 24h \<1.0 g * Hepatic: Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN * Coagulation: INR and APTT ≤1.5×ULN * Cardiac: LVEF ≥50% * Women of childbearing potential: a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, and the serum result will be considered definitive).If a female participant of childbearing potential engages in sexual activity with a male partner who is not surgically sterile, she must use an acceptable method of contraception starting from screening and agree to continue using the same contraception for 120 days after the last dose of study drug. Whether to discontinue contraception after this period should be discussed with the investigator * Willingness to comply with the study procedures before study entry Main Exclusion Criteria: * Cervical cancer of other histology (e.g., neuroendocrine carcinoma, sarcoma) * Evidence of distant metastasis * Prior total hysterectomy (subtotal or cervical-sparing surgery allowed) * Unable or unwilling to receive brachytherapy * Prior treatment with immune checkpoint inhibitors or other tumor immunotherapy * Systemic corticosteroid (\>10 mg/day prednisone or equivalent) or immunosuppressive therapy within 2 weeks (exceptions: inhaled/topical ≤10 mg/day, physiologic replacement ≤10 mg/day, premedication for hypersensitivity). * Immunomodulatory drugs within 2 weeks (e.g., thymosin, interferons, IL-2)
Where this trial is running
Beijing
- National Cancer Center/Cancer Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.