Recurrent Cervical CancerNCT07186868
QL706 + Chemo ± Bevacizumab in Anti-PD-(L)1-Resistant R/M Cervical Cancer
An observational study of Recurrent Cervical Cancer and Metastatic Cervical Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This is a clinical research study for women with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1/PD-L1 inhibitor immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Cervical Cancer, Metastatic Cervical Cancer
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 30 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: This study will enroll adult female patients (aged 18-75) with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1 or PD-L1 inhibitor. Participants must have at least one measurable lesion, an ECOG performance status of 0 or 1, and adequate organ function.
Who may be able to join
- Female patients aged 18 to 75 years.
- Histologically, pathologically, or radiologically confirmed recurrent or metastatic cervical cancer.
- At least one measurable lesion as defined by RECIST 1.1 (non-nodal lesion longest diameter ≥10 mm or lymph node short axis ≥15 mm).
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Disease progression after receiving at least one prior anti-PD-1/PD-L1 monoclonal antibody therapy (alone or in combination).
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- Adequate organ function within 14 days before enrollment:
- Absolute neutrophil count (ANC) >1.5 × 10⁹/L Platelets >100 × 10⁹/L Hemoglobin >100 g/L Serum total bilirubin <1.5 × ULN ALT and AST <3 × ULN Creatinine clearance (CCr) >60 mL/min
- Voluntarily sign the informed consent form, able to understand and comply with study requirements.
Who cannot join
- Known allergy to any component of the study drugs.
- Prior treatment with any CTLA-4 targeting medication.
- Adverse reactions from previous anti-cancer therapy have not recovered to ≤ Grade 1 (per CTCAE v5.0) (except for toxicities without safety risk per investigator's judgment, e.g., alopecia).
- History of other malignancies within the past 5 years, except for cured malignancies.
- Severe comorbid conditions, including but not limited to:
- Extensive interstitial lung disease requiring medication. Active or uncontrolled infections (e.g., tuberculosis, HIV). Decompensated liver disease, active hepatitis, or active bleeding. History of cerebrovascular accident or pulmonary embolism. Active, known, or suspected autoimmune diseases. Active infection requiring systemic anti-infective therapy.
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- Ascites with depth >5 cm measured by ultrasound or CT, OR ascites causing severe symptoms (e.g., abdominal distension, dyspnea, circulatory dysfunction) significantly impacting physical function or study safety.
- Pregnant, planning pregnancy, or lactating women.
- Any other condition deemed by the investigator as unsuitable for participation in this study.
About this study
Official title: A Prospective, Open-Label, Single-Arm Study of Iparomlimab and Toripalimab Plus Nab-Paclitaxel With or Without Bevacizumab in Recurrent/Metastatic Cervical Cancer Progressed on Anti-PD-(L)1 Therapy
This is a clinical research study for women with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1/PD-L1 inhibitor immunotherapy.
The study will evaluate the effectiveness and safety of a new combination treatment consisting of iparvolimab and tuvonralimab (QL1706)-a dual-targeting immunotherapy drug-along with chemotherapy (nab-paclitaxel) with or without bevacizumab, an anti-angiogenic drug that may help prevent tumor growth.
Read more
Approximately 25 participants will be enrolled in this open-label, single-arm study. All participants will receive the study treatment for up to 6 cycles, followed by maintenance therapy until disease progression, unacceptable side effects, or other reasons for stopping treatment.
The main goal of the study is to see how many patients respond to the treatment (Objective Response Rate, ORR). Other goals include measuring how long the response lasts, how long patients live without the cancer getting worse, and overall survival. Safety and quality of life will also be closely monitored.
This study is for women aged 18-75 who have previously received PD-1/PD-L1 treatment and whose cancer has worsened. Participants must be in generally good health with adequate organ function and no other active cancers.
The study will be conducted at a single center in China. All participants will provide written informed consent before joining the study.
Read the detailed description
This is a prospective, open-label, single-arm, single-center phase II clinical trial investigating the efficacy and safety of a combination therapy in patients with recurrent or metastatic cervical cancer who have experienced disease progression following prior anti-PD-1/PD-L1 therapy.
The study aims to address the high unmet medical need in this patient population where treatment options are limited after failure of immunotherapy. The investigational regimen consists of iparomlimab and tuvonralimab (QL1706), a novel bifunctional antibody targeting both PD-1 and CTLA-4, combined with nab-paclitaxel chemotherapy, with the optional addition of bevacizumab at the investigator's discretion.
Approximately 25 participants will receive the combination treatment for 6 cycles (3-week cycles), followed by maintenance therapy with QL1706 ± bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met. The primary endpoint is Objective Response Rate (ORR) per RECIST 1.1. Secondary endpoints include Progression-Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), Overall Survival (OS), and safety profile. An exploratory objective will analyze the correlation between PD-L1 expression status and treatment outcomes.
The study will include rigorous safety monitoring per NCI CTCAE v5.0 guidelines and regular tumor assessments. The sample size was calculated based on the assumption of improving the ORR from a historical control of 15% to 40% with the new combination.
- Being tested
- Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab
- 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) + Nab-Paclitaxelwith or without BevacizumabBiological
All participants will receive the study intervention: Iparomlimab and Tuvonralimab (QL1706) at 5.0 mg/kg IV Q3W + Nab-Paclitaxel at 260 mg/m² IV Q3W, with or without Bevacizumab (7.5-15 mg/kg IV Q3W) per investigator's choice, for 6 cycles. This is followed by maintenance therapy with QL1706 ± Bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + Nab-Paclitaxel ± Bevacizumab | All participants will receive the study intervention: Iparomlimab and Tuvonralimab (QL1706) at 5.0 mg/kg IV Q3W + Nab-Paclitaxel at 260 mg/m² IV Q3W, with or without Bevacizumab (7.5-15 mg/kg IV Q3W) per investigator's choice, for 6 cycles. This is followed by maintenance therapy with QL1706 ± Bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Receives: Biological: Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor assessments are performed by the investigators via computed tomography (CT) or magnetic resonance imaging (MRI) scans.
Measured: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months)
Secondary outcomes (4)
Progression-Free Survival (PFS)
The time from the start of study treatment until the first documentation of disease progression as per RECIST 1.1, or death from any cause, whichever occurs first.
Measured: From enrollment until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
Duration of Response (DoR)
The time from the first documentation of objective response (CR or PR) per RECIST 1.1 until the first documentation of disease progression or death from any cause.
Measured: From the first recorded response until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
Disease Control Rate (DCR)
The proportion of participants who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1, maintained for at least 4 weeks.
Measured: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months).
Overall Survival (OS)
The time from the start of study treatment until death from any cause.
Measured: From enrollment until death from any cause (assessed every 12 weeks during follow-up for up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Cervical CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186868
- Sponsor's protocol ID
- NCC-01
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Study of Iparomlimab and Toripalimab Plus Nab-Paclitaxel With or Without Bevacizumab in Recurrent/Metastatic Cervical Cancer Progressed on Anti-PD-(L)1 Therapy
- ClinicalTrials.gov ID
- NCT07186868
- Acronym / sponsor ID
- NCC-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Sep 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 is a clinical research study for women with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1/PD-L1 inhibitor immunotherapy.
The study will evaluate the effectiveness and safety of a new combination treatment consisting of iparvolimab and tuvonralimab (QL1706)-a dual-targeting immunotherapy drug-along with chemotherapy (nab-paclitaxel) with or without bevacizumab, an anti-angiogenic drug that may help prevent tumor growth.
Approximately 25 participants will be enrolled in this open-label, single-arm study. All participants will receive the study treatment for up to 6 cycles, followed by maintenance therapy until disease progression, unacceptable side effects, or other reasons for stopping treatment.
The main goal of the study is to see how many patients respond to the treatment (Objective Response Rate, ORR). Other goals include measuring how long the response lasts, how long patients live without the cancer getting worse, and overall survival. Safety and quality of life will also be closely monitored.
This study is for women aged 18-75 who have previously received PD-1/PD-L1 treatment and whose cancer has worsened. Participants must be in generally good health with adequate organ function and no other active cancers.
The study will be conducted at a single center in China. All participants will provide written informed consent before joining the study.
Detailed description
This is a prospective, open-label, single-arm, single-center phase II clinical trial investigating the efficacy and safety of a combination therapy in patients with recurrent or metastatic cervical cancer who have experienced disease progression following prior anti-PD-1/PD-L1 therapy.
The study aims to address the high unmet medical need in this patient population where treatment options are limited after failure of immunotherapy. The investigational regimen consists of iparomlimab and tuvonralimab (QL1706), a novel bifunctional antibody targeting both PD-1 and CTLA-4, combined with nab-paclitaxel chemotherapy, with the optional addition of bevacizumab at the investigator's discretion.
Approximately 25 participants will receive the combination treatment for 6 cycles (3-week cycles), followed by maintenance therapy with QL1706 ± bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met. The primary endpoint is Objective Response Rate (ORR) per RECIST 1.1. Secondary endpoints include Progression-Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), Overall Survival (OS), and safety profile. An exploratory objective will analyze the correlation between PD-L1 expression status and treatment outcomes.
The study will include rigorous safety monitoring per NCI CTCAE v5.0 guidelines and regular tumor assessments. The sample size was calculated based on the assumption of improving the ORR from a historical control of 15% to 40% with the new combination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 + Nab-Paclitaxel ± Bevacizumab | – | Biological: Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without BevacizumabAll participants will receive the study intervention: Iparomlimab and Tuvonralimab (QL1706) at 5.0 mg/kg IV Q3W + Nab-Paclitaxel at 260 mg/m² IV Q3W, with or without Bevacizumab (7.5-15 mg/kg IV Q3W) per investigator's choice, for 6 cycles. This is followed by maintenance therapy with QL1706 ± Bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adult female patients (aged 18-75) with recurrent or metastatic cervical cancer whose disease has progressed after prior treatment with a PD-1 or PD-L1 inhibitor. Participants must have at least one measurable lesion, an ECOG performance status of 0 or 1, and adequate organ function.
Key inclusion criteria (9 listed)
- Female patients aged 18 to 75 years.
- Histologically, pathologically, or radiologically confirmed recurrent or metastatic cervical cancer.
- At least one measurable lesion as defined by RECIST 1.1 (non-nodal lesion longest diameter ≥10 mm or lymph node short axis ≥15 mm).
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
Key exclusion criteria (9 listed)
- Known allergy to any component of the study drugs.
- Prior treatment with any CTLA-4 targeting medication.
- Adverse reactions from previous anti-cancer therapy have not recovered to ≤ Grade 1 (per CTCAE v5.0) (except for toxicities without safety risk per investigator's judgment, e.g., alopecia).
- History of other malignancies within the past 5 years, except for cured malignancies.
- Severe comorbid conditions, including but not limited to:
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) + Nab-Paclitaxelwith or without BevacizumabAll participants will receive the study intervention: Iparomlimab and Tuvonralimab (QL1706) at 5.0 mg/kg IV Q3W + Nab-Paclitaxel at 260 mg/m² IV Q3W, with or without Bevacizumab (7.5-15 mg/kg IV Q3W) per investigator's choice, for 6 cycles. This is followed by maintenance therapy with QL1706 ± Bevacizumab until disease progression, unacceptable toxicity, or other discontinuation criteria are met. | Biological | QL1706 + Nab-Paclitaxel ± Bevacizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months)
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor assessments are performed by the investigators via computed tomography (CT) or magnetic resonance imaging (MRI) scans.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
Duration of Response (DoR)
Time frame: From the first recorded response until disease progression or death (assessed approximately every 8 weeks for up to 24 months).
Disease Control Rate (DCR)
Time frame: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for up to 24 months).
Overall Survival (OS)
Time frame: From enrollment until death from any cause (assessed every 12 weeks during follow-up for up to 24 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 22 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Cervical Cancer and Metastatic Cervical Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 9 inclusion and 9 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 Sep 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From enrollment until disease progression, unacceptable toxicity, or any other discontinuation criterion is met (assessed approximately every 8 weeks for 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 22 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.