METASTATIC CERVICAL CANCERPhase 3NCT05446883
QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
A Phase 3 study testing QL1706, Paclitaxel injection and Cisplatin/Carboplatin in people with METASTATIC CERVICAL CANCER, run by Qilu Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- METASTATIC CERVICAL CANCER
- What is being tested?
- QL1706, Paclitaxel injection and Cisplatin/Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 3 sitesChina
- Study dates
- 23 Sep 2022to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- The subject fully understood and voluntarily signed the informed consent form.
- Histologically confirmed cervical cancer.
- At least one measurable tumor lesion by CT or MRI according to RECIST 1.1 criteria.
- All subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained FFPE pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥ 12 weeks.
- Adequate level of vital organ function
Who cannot join
- Previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; previously received VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors.
- Systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever > 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator)
- Within two weeks before randomization, there is a need for systemic use of corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) treatment of the disease; Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are permitted for the prevention of contrast allergy。
- Systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Qi Zhou
Dongling Zou
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu, Doctor, 13826299236, LiuJH@sysucc.org.cn
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000
Danbo Wang
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate QL1706 Plus Paclitaxel-Cisplatin/Carboplatin With or Without Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab
Read the detailed description
Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS < 1 vs 1 ≤ CPS < 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab
- Conditions
- METASTATIC CERVICAL CANCER
- Being tested
- QL1706, Placebo, Paclitaxel injection, Cisplatin/Carboplatin
- 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.
QL1706Drug
Intravenous Infusion
PlaceboDrug
Intravenous Infusion
Paclitaxel injectionDrug
Intravenous Infusion
Cisplatin/CarboplatinDrug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| QL1706+chemotherapy± bevacizumab | Experimental | QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg) Receives: Drug: QL1706; Drug: Paclitaxel injection; Drug: Cisplatin/Carboplatin |
| Placebo+chemotherapy± bevacizumab | Placebo comparator | Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg) Receives: Drug: Placebo; Drug: Paclitaxel injection; Drug: Cisplatin/Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS by BICR based on RECIST v1.1
PFS by BICR based on RECIST v1.1
Measured: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
OS
OS
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
Secondary outcomes (1)
PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria
PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria
Measured: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start23 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for METASTATIC CERVICAL CANCERStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446883
- Sponsor's protocol ID
- QL1706-301
- Status last verified
- Nov 2022
- First submitted
- 28 Jun 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Involves subject privacy and does not intend to share
Publications
Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.
PubMed 37158938
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate QL1706 Plus Paclitaxel-Cisplatin/Carboplatin With or Without Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT05446883
- Acronym / sponsor ID
- QL1706-301
- Conditions
- METASTATIC CERVICAL CANCER
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 7 Jul 2022 (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 randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab
Detailed description
Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS < 1 vs 1 ≤ CPS < 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706+chemotherapy± bevacizumab | Experimental | Drug: QL1706, Drug: Paclitaxel injection, Drug: Cisplatin/CarboplatinQL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg) |
| Placebo+chemotherapy± bevacizumab | Placebo comparator | Drug: Placebo, Drug: Paclitaxel injection, Drug: Cisplatin/CarboplatinPlacebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject fully understood and voluntarily signed the informed consent form.
- Histologically confirmed cervical cancer.
- At least one measurable tumor lesion by CT or MRI according to RECIST 1.1 criteria.
- All subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained FFPE pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; previously received VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors.
- Systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever > 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator)
- Within two weeks before randomization, there is a need for systemic use of corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) treatment of the disease; Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are permitted for the prevention of contrast allergy。
- Systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization
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 |
|---|---|---|
| QL1706Intravenous Infusion | Drug | QL1706+chemotherapy± bevacizumab |
| PlaceboIntravenous Infusion | Drug | Placebo+chemotherapy± bevacizumab |
| Paclitaxel injectionIntravenous Infusion | Drug | Placebo+chemotherapy± bevacizumab, QL1706+chemotherapy± bevacizumab |
| Cisplatin/CarboplatinIntravenous Infusion | Drug | Placebo+chemotherapy± bevacizumab, QL1706+chemotherapy± bevacizumab |
Primary outcome
PFS by BICR based on RECIST v1.1
Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
PFS by BICR based on RECIST v1.1
OS
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
OS
1 secondary outcome
PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria
Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Derived from this study: PubMed 37158938Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.
- Individual participant dataSharing planned: No. Involves subject privacy and does not intend to share
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1706, Paclitaxel injection and Cisplatin/Carboplatin in people with METASTATIC CERVICAL CANCER, run by Qilu Pharmaceutical Co., Ltd. at 3 sites 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Zhang (008610-50813552, xiaoli3.zhang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS by BICR based on RECIST v1.1 (time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)). The study lists 2 primary outcomes in all. 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 NCT05446883, which also lists 1 linked publication.
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 30 Nov 2022.