Iparomlimab/Tuvonralimab with concurrent chemoradiation for locally advanced cervical cancer
Official title: 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
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT07232654 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy, prednisone, Iparomlimab, Tuvonralimab |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | November 11, 2025 |
| Main results expected | November 30, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07232654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
National Cancer Center/Cancer Hospital
Beijing, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer
In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.
-
Iparomlimab/Tuvonralimab with nab-paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer
This trial tests whether adding Iparomlimab/Tuvonralimab to nab-paclitaxel and cisplatin before surgery can shrink locally advanced cervical cancer and safely be given to adult women.
-
Neoadjuvant immunotherapy plus Nab-P-SOX for locally advanced gastric/GEJ cancer
This phase 2, single-arm study tests a pre-surgery treatment that combines a PD-1/CTLA-4 bispecific antibody with nab-paclitaxel, oxaliplatin, and S-1 in adults with HER2-negative, locally advanced gastric or GEJ cancer.
-
Cryoablation with liver-directed immunotherapy and targeted therapy for melanoma liver metastases
This trial tests a combination therapy including cryoablation, hepatic artery delivery of QL1706, intravenous dacarbazine, and oral lenvatinib to treat liver metastases from malignant melanoma in adults.
-
HAIC plus QL1706 and bevacizumab as first-line therapy for unresectable HER2-negative intrahepatic cholangiocarcinoma
This study tests a liver-directed chemotherapy plus immune therapy and a blood vessel blocker to see if it helps people with unresectable intrahepatic cholangiocarcinoma.
-
Iparomlimab and Tuvonralimab with SBRT and Lenvatinib for Potentially Resectable Intermediate-Stage HCC
This trial tests whether adding two antibodies together with SBRT and lenvatinib can improve outcomes for adults with potentially resectable intermediate-stage hepatocellular carcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.