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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab/Tuvonralimab | Drug | IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year PFS rate | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Up to approximately 24 months | |
| PFS | Up to approximately 24 months | |
| DCR |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin |
| Drug |
IV infusion |
|
| Brachytherapy and External Beam Radiotherapy | Radiation | Radiation |
|
| Up to approximately 24 months |
| DoR | Up to approximately 24 months |
| OS | Up to approximately 36 months |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011878 |
| Radiotherapy |
| D013812 | Therapeutics |