QL706 + Chemo ± Bevacizumab in Anti-PD-(L)1-Resistant R/M Cervical Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab (QL1706) + Nab-Paclitaxelwith or without Bevacizumab

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

This trial has no locations