Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: LOCALLY ADVANCED CERVICAL CANCERS

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07232654

QLMA-IIT-CC-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Arm 1

Experimental group

Description:

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.

Treatment:

Radiation: Brachytherapy and External Beam Radiotherapy

Drug: Iparomlimab/Tuvonralimab

Drug: Cisplatin

Arm 2

Experimental group

Description:

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.

Treatment:

Radiation: Brachytherapy and External Beam Radiotherapy

Drug: Iparomlimab/Tuvonralimab

Drug: Cisplatin