Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC

NCT07232654 | Recruiting Phase 2

• 1 other identifier: QLMA-IIT-CC-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

LOCALLY ADVANCED CERVICAL CANCERS

Keywords

QL1706; Concurrent Chemoradiation Therapy; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• 2-year PFS rate

  up to 24 months

Secondary Outcomes (5)

• ORR

  Up to approximately 24 months

• PFS

  Up to approximately 24 months

• DCR

  Up to approximately 24 months

• DoR

  Up to approximately 24 months

• OS

  Up to approximately 36 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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: Iparomlimab/Tuvonralimab; Drug: Cisplatin; Radiation: Brachytherapy and External Beam Radiotherapy

Arm 2

EXPERIMENTAL

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: Iparomlimab/Tuvonralimab; Drug: Cisplatin; Radiation: Brachytherapy and External Beam Radiotherapy

Interventions

Iparomlimab/Tuvonralimab DRUG

IV infusion

Arm 1; Arm 2

Cisplatin DRUG

IV infusion

Arm 1; Arm 2

Brachytherapy and External Beam Radiotherapy RADIATION

Radiation

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

National Cancer Center/Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-10

Locations

CN (1)