Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC

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 study is 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.

Study Overview

• Status: Recruiting
• Conditions: LOCALLY ADVANCED CERVICAL CANCERS
• Intervention / Treatment: Drug: Cisplatin; Drug: Iparomlimab/Tuvonralimab; Radiation: Brachytherapy and External Beam Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • National Cancer Center/Cancer Hospital
    • Contact: Iparomlimab/Tuvonralimab injection plus CCRT in LACC; Phone Number: 010-67781331; Email: cancergcp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Participants will receive 1 cycle of Iparomlimab/Tuvonralimab induction therapy followed by concurrent chemotherapy and radiotherapy. Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.	Drug: Cisplatin; IV infusion; Drug: Iparomlimab/Tuvonralimab; IV infusion; Radiation: Brachytherapy and External Beam Radiotherapy; Radiation
Experimental: Arm 2; Participants will receive Iparomlimab/Tuvonralimab combined with concurrent chemotherapy and radiotherapy. Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.	Drug: Cisplatin; IV infusion; Drug: Iparomlimab/Tuvonralimab; IV infusion; Radiation: Brachytherapy and External Beam Radiotherapy; Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year PFS rate	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
OS	Up to approximately 36 months
ORR	Up to approximately 24 months
PFS	Up to approximately 24 months
DCR	Up to approximately 24 months
DoR	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Cervical cancer; Concurrent Chemoradiation Therapy; QL1706
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Therapeutics; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Cisplatin; Brachytherapy
• Other Study ID Numbers: QLMA-IIT-CC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No