LOCALLY ADVANCED CERVICAL CANCERSPhase 2NCT07232654
Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC
A Phase 2 study testing Iparomlimab/Tuvonralimab, Cisplatin and Brachytherapy and External Beam Radiotherapy in people with LOCALLY ADVANCED CERVICAL CANCERS, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- LOCALLY ADVANCED CERVICAL CANCERS
- What is being tested?
- Iparomlimab/Tuvonralimab, Cisplatin and Brachytherapy and External Beam Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 28 Feb 2028
- 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
- 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
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- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital
Beijing
Iparomlimab/Tuvonralimab injection plus CCRT in LACC, 010-67781331, cancergcp@163.com
About this study
Official title: 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.
- Conditions
- LOCALLY ADVANCED CERVICAL CANCERS
- Being tested
- Iparomlimab/Tuvonralimab, Cisplatin, Brachytherapy and External Beam Radiotherapy
- Keywords
- QL1706, Concurrent Chemoradiation Therapy, Cervical cancer
- 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/TuvonralimabDrug
IV infusion
CisplatinDrug
IV infusion
Brachytherapy and External Beam RadiotherapyRadiation
Radiation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Iparomlimab/Tuvonralimab; Drug: Cisplatin; Radiation: Brachytherapy and External Beam Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS rate
Measured: up to 24 months
Secondary outcomes (5)
ORR
Measured: Up to approximately 24 months
PFS
Measured: Up to approximately 24 months
DCR
Measured: Up to approximately 24 months
DoR
Measured: Up to approximately 24 months
OS
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start11 Nov 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOCALLY ADVANCED CERVICAL CANCERSStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LING YING WU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232654
- Sponsor's protocol ID
- QLMA-IIT-CC-001
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07232654
- Acronym / sponsor ID
- QLMA-IIT-CC-001
- Conditions
- LOCALLY ADVANCED CERVICAL CANCERS
- Keywords
- QL1706, Concurrent Chemoradiation Therapy, Cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Nov 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Iparomlimab/Tuvonralimab, Drug: Cisplatin, Radiation: Brachytherapy and External Beam RadiotherapyParticipants 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 | Drug: Iparomlimab/Tuvonralimab, Drug: Cisplatin, Radiation: Brachytherapy and External Beam RadiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (0 listed)
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/TuvonralimabIV infusion | Drug | Arm 1, Arm 2 |
| CisplatinIV infusion | Drug | Arm 1, Arm 2 |
| Brachytherapy and External Beam RadiotherapyRadiation | Radiation | Arm 1, Arm 2 |
Primary outcome
2-year PFS rate
Time frame: up to 24 months
5 secondary outcomes
ORR
Time frame: Up to approximately 24 months
PFS
Time frame: Up to approximately 24 months
DCR
Time frame: Up to approximately 24 months
DoR
Time frame: Up to approximately 24 months
OS
Time frame: Up to approximately 36 months
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 1 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab/Tuvonralimab, Cisplatin and Brachytherapy and External Beam Radiotherapy in people with LOCALLY ADVANCED CERVICAL CANCERS, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 23 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS rate (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.