Cervical CancerPhase 2NCT06986057

Iparomlimab and Tuvonralimab Combined With Platinum-Based Chemotherapy for Neoadjuvant Treatment of Cervical Cancer

A Phase 2 study testing Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy in people with Cervical Cancer and Neoadjuvant Therapy, run by Shandong Tumor Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Cervical Cancer, Neoadjuvant Therapy
What is being tested?: Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: No sites listed yet
Study dates: 31 May 2025to 31 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntary signing of written Informed Consent Form (ICF).
Age ≥18 years and ≤75 years at enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) with clinical staging by FIGO 2018 criteria: IB3, IIA2, IIB, or IIIC (parametrial invasion without reaching the pelvic wall, no vaginal lower third involvement).
No prior systemic or local antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy) for cervical cancer prior to the first dose of study treatment.
Agreement to undergo radical hysterectomy with no surgical contraindications as judged by the investigator.

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At least one untreated measurable lesion according to RECIST v1.1.
Consent to provide tumor tissue and peripheral blood samples during the screening period and study procedures for related research.
Adequate organ function:
Hematology (no blood components or growth factor support within 7 days before study treatment): i. Absolute neutrophil count (ANC) ≥1.5×10⁹/L (1,500/mm³); ii. Platelet count ≥100×10⁹/L (100,000/mm³); iii. Hemoglobin ≥90 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula); ii. Urine protein <2+ or 24-hour urine protein <1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Albumin (ALB) ≥28 g/L. d) Coagulation: i. INR and APTT ≤1.5×ULN (stable anticoagulation therapy allowed if parameters remain within therapeutic range).
Cardiac: i. Left ventricular ejection fraction (LVEF) ≥50%.
Fertile women must have a negative urine or serum pregnancy test within 3 days before first dose. If urine test is inconclusive, serum testing is required. Contraception must be used from screening until 120 days post-treatment. Barrier methods or hormonal contraceptives (e.g., pills) are required.
Fertile women: Not surgically sterilized (e.g., bilateral tubal ligation) or premenopausal (≥12 months amenorrhea with FSH in postmenopausal range).
Effective contraception: Methods with <1% failure rate (e.g., hormonal contraceptives).
Willingness and ability to comply with scheduled visits, protocols, labs, and study requirements.
Expected survival ≥6 months.

Who cannot join

Histopathological type other than cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, sarcoma).
History of other malignancies within 3 years prior to enrollment, excluding localized malignancies cured by local therapy (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast).
Simultaneous enrollment in another clinical study, unless it is an observational, non-interventional study or within the follow-up period of an interventional study.
Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor) within 2 weeks prior to first dose; herbal or proprietary Chinese medicine with antitumor indications within 1 week prior to first dose.
Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal/pituitary insufficiency) is not considered systemic therapy.
History of non-infectious pneumonia requiring systemic corticosteroids or current interstitial lung disease.

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Significant bleeding diathesis or coagulation dysfunction.
Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease/gastritis, or psychiatric/social conditions impairing compliance or informed consent.
History of myocarditis, cardiomyopathy, or malignant arrhythmias. Within 12 months prior to first dose: unstable angina, congestive heart failure, or vascular disease requiring hospitalization (e.g., surgical repair of aortic aneurysm/peripheral venous thrombosis). Within 6 months prior: esophageal-gastric varices, unhealed wounds, gastrointestinal perforation, fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding. Arterial thromboembolism, NCI CTCAE 5.0 grade ≥3 venous thromboembolism, transient ischemic attack, stroke, hypertensive crisis, or hypertensive encephalopathy. Within 1 month prior: acute exacerbation of COPD. Current hypertension uncontrolled with oral antihypertensives (SBP ≥160 mmHg or DBP ≥100 mmHg).
Active or history of definite inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
Severe infection within 4 weeks prior to first dose (including hospitalization, sepsis, or severe pneumonia). Active infection requiring systemic antimicrobial therapy within 10 days prior (excluding HBV/HCV antiviral therapy).
Major surgery or severe trauma within 30 days prior to first dose; minor local procedures (excluding peripherally inserted central catheter placement) within 3 days prior.
History of immunodeficiency, HIV seropositivity, or current long-term systemic corticosteroid/immunosuppressant use.
Active pulmonary tuberculosis (TB) or suspected TB requiring clinical exclusion (e.g., sputum AFB, chest X-ray).
Active syphilis infection.
History of allogeneic organ or hematopoietic stem cell transplantation.
Untreated active HBV (HBsAg+ with HBV-DNA >1000 copies/mL [200 IU/mL] or above limit of detection). HBV patients must receive antiviral therapy during study. Active HCV (HCV Ab+ with HCV-RNA above limit of detection).
Live vaccine administration within 30 days prior to first dose or planned during study.
Known hypersensitivity to any study drug component or severe allergic reaction to other monoclonal antibodies.
History of psychiatric disorders, substance abuse, alcoholism, or drug addiction.
Pregnancy or lactation.
Any disease, treatment, or laboratory abnormality that may confound study results, hinder compliance, or compromise participant safety.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Li contact

011+86+15553115531

drldp@126.com

About this study

Official title: Iparomlimab and Tuvonralimab (QL1706) Combined With Platinum-Based Chemotherapy for Neoadjuvant Treatment of Cervical Cancer: A Single-Arm Phase II Clinical Trial

The primary objective of this study is to evaluate the efficacy and safety of Iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy for cervical cancer neoadjuvant therapy. Additionally, the study aims to identify potential predictive biomarkers for therapeutic efficacy by analyzing tumor tissues and peripheral blood samples from participants receiving this combined treatment regimen.

Conditions: Cervical Cancer, Neoadjuvant Therapy
Being tested: Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy
Keywords: immunotherapy, PD-1 Inhibitor, CTLA-4 Inhibitor
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapyDrug
Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy

Study groups in NCT06986057
Study group	Role	What they receive
Experimental Group	Experimental	Evaluation of the Efficacy of Iparomlimab and Tuvonralimab in Combination with Platinum-Based Chemotherapy for Neoadjuvant Therapy of Cervical Cancer Receives: Drug: Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

CR/PR rate (%) in subjects with ≥1 response event
The ORR assessment will include data obtained before surgery or until disease progression (whichever occurs first), or until the last evaluable assessment data before surgery if no disease progression has occurred.
Measured: 4 months after the patient was enrolled in the study

Secondary outcomes (5)

pCR rate (%) post neoadjuvant therapy
The proportion of patients with no residual tumor cells in the tumor tissue specimens obtained through surgical resection after neoadjuvant therapy.
Measured: 6 months after the patient was enrolled in the study
Time to first event post-neoadjuvant therapy
The time from the start of neoadjuvant therapy to the occurrence of any of the following events for the patient: disease progression, local or distant recurrence diagnosed by imaging or biopsy, death due to any cause, etc.
Measured: 2 years after the patient was enrolled in the study
Patients whose residual active tumor cells are ≤ 10% after neoadjuvant therapy
MPR（Major Pathological Response） rate = (Number of subjects achieving MPR / Total number of subjects) × 100%.
Measured: 6 months after the patient was enrolled in the study
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 2 years after the patient was enrolled in the study
Surgical Delay Rate (%)
rate = delayed cases / total cases × 100%
Measured: 6 months after the patient was enrolled in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202531 Dec 2026

First posted22 May 2025
Study start31 May 2025 (estimated)
Primary completion31 Jul 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06986057
Sponsor's protocol ID: QLMA-CC-IIT-003
Status last verified: Apr 2025
First submitted: 16 Apr 2025
Last updated: 22 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Iparomlimab and Tuvonralimab (QL1706) Combined With Platinum-Based Chemotherapy for Neoadjuvant Treatment of Cervical Cancer: A Single-Arm Phase II Clinical Trial
ClinicalTrials.gov ID: NCT06986057
Acronym / sponsor ID: QLMA-CC-IIT-003
Conditions: Cervical Cancer, Neoadjuvant Therapy
Keywords: immunotherapy, PD-1 Inhibitor, CTLA-4 Inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 28 participants (estimated)
Lead sponsor: Shandong Tumor HospitalUniversity, hospital or other
Study start: 31 May 2025 (estimated)
Primary completion: 31 Jul 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 22 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental Group	Experimental	Drug: Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapyEvaluation of the Efficacy of Iparomlimab and Tuvonralimab in Combination with Platinum-Based Chemotherapy for Neoadjuvant Therapy of Cervical Cancer

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Voluntary signing of written Informed Consent Form (ICF).
Age ≥18 years and ≤75 years at enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) with clinical staging by FIGO 2018 criteria: IB3, IIA2, IIB, or IIIC (parametrial invasion without reaching the pelvic wall, no vaginal lower third involvement).
No prior systemic or local antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy) for cervical cancer prior to the first dose of study treatment.

Key exclusion criteria (22 listed)

Histopathological type other than cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, sarcoma).
History of other malignancies within 3 years prior to enrollment, excluding localized malignancies cured by local therapy (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast).
Simultaneous enrollment in another clinical study, unless it is an observational, non-interventional study or within the follow-up period of an interventional study.
Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor) within 2 weeks prior to first dose; herbal or proprietary Chinese medicine with antitumor indications within 1 week prior to first dose.
Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal/pituitary insufficiency) is not considered systemic therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapyIparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy	Drug	Experimental Group

Primary outcome

CR/PR rate (%) in subjects with ≥1 response event
Time frame: 4 months after the patient was enrolled in the study
The ORR assessment will include data obtained before surgery or until disease progression (whichever occurs first), or until the last evaluable assessment data before surgery if no disease progression has occurred.

5 secondary outcomes

pCR rate (%) post neoadjuvant therapy
Time frame: 6 months after the patient was enrolled in the study
Time to first event post-neoadjuvant therapy
Time frame: 2 years after the patient was enrolled in the study
Patients whose residual active tumor cells are ≤ 10% after neoadjuvant therapy
Time frame: 6 months after the patient was enrolled in the study
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 2 years after the patient was enrolled in the study
Surgical Delay Rate (%)
Time frame: 6 months after the patient was enrolled in the study

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Li contact

011+86+15553115531

drldp@126.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy in people with Cervical Cancer and Neoadjuvant Therapy, run by Shandong Tumor Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li (011+86+15553115531, drldp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR/PR rate (%) in subjects with ≥1 response event (time frame: 4 months after the patient was enrolled in the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06986057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.