Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-31 @ 6:00 AM
Study NCT ID:
NCT07186868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QL706 + Chemo ± Bevacizumab in Anti-PD-(L)1-Resistant R/M Cervical Cancer
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: