A Study of QL1706 (an Anti-PD-1/CTLA-4 Combined Antibody) Combined With Albumin-bound Paclitaxel and Bevacizumab in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

NCT06509971 | Not Yet Recruiting Phase 2

• 1 other identifier: WCSUH20240707
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Major objectives To evaluate the efficacy of QL1706 combined with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer.
• Secondary Purpose To evaluate the safety of QL1706 in combination with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer. Exploratory analysis of the association between the efficacy of the combination regimen and biomarkers.

Conditions

Platinum-resistant Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Defined as the proportion of subjects achieving optimal total efficacy (Bor) as confirmed Cr or PR (according to RECIST v1.1) . The best overall response was defined as the best response recorded (in order of CR, PR, SD, PD, or non-evaluable) from the beginning of treatment until disease progression, or in cases where PD was not achieved before the initiation of subsequent antitumour therapy or before study discontinuation (whichever occurred first) , the best efficacy was recorded (from the start of treatment until the last evaluable tumour imaging assessment) .

  up to 6 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

QL1706: 5 mg/kg Q3W, IV , up to 34 courses. Albumin-binding paclitaxel: 260 mg/m2 Q3W, IV, 6 courses. Bevacizumab: 15 mg/kg Q3W, IV, up to 22 courses.

Drug: QL1706

Interventions

QL1706 DRUG

The Order of Drug Administration was: QL1706→ bevacizumab → albumin-binding paclitaxel, and each drug was administered at least 30 minutes apart. QL1706: 5 mg/kg Q3W. The infusion time was 30 minutes + 5 minutes. No dose adjustment was allowed for QL1706 during treatment, but delayed administration was allowed, with a delay of no more than 4 weeks from the previous dose. Albumin-binding paclitaxel: 260 mg/m 2 Q3W, IV, for 30 min + 5 min. During treatment, albumin-binding paclitaxel allows for dose adjustments. Bevacizumab: 15 mg/kg Q3 W, iv. The first infusion should last 90 minutes. If the first infusion was well tolerated, the second infusion could be shortened to 60 minutes. If the patient is also well-tolerated for a 60-minute infusion, then all subsequent infusions can be completed in 30 minutes, no dose adjustment is allowed for bevacizumab.

Also known as: bevacizumab, albumin-binding paclitaxel

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signing of a written ICF.
• Age ≥18 years, ≤75 years, female.
• The Eastern Cooperative Oncology Group (ECOG) physical fitness score was 0 or 1.
• Expected survival ≥3 months.
• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• Patients with platinum-resistant recurrent ovarian cancer (including fallopian tube and peritoneal cancer) were defined as progression within 6 months after platinum-based chemotherapy.
• At least one measurable lesion according to RECIST v1.1, and this lesion is amenable to repeated accurate measurements according to RECIST v1.1. Lesions that have received radiation therapy can be considered as target lesions if they are clearly progressive and measurable on the basis of imaging.
• Determination of good organ function through the following requirements:
• A) hematology (no blood component and cell growth factor support therapy was used for 7 days before study initiation) :
• I. ANC ≥1.5 × 109 L (1.500 MM3) in absolute neutrophil; II. Platelet count ≥100 × 109/L (100,000/MM3) ; III. Hemoglobin ≥90 g/L.
• B) kidneys:
• I. Creatinine clearance \* (CrCl) calculated value ≥50 mL/min
• \* CrCl (Cockcroft-gault formula) will be calculated using Cockcroft-Gault formula CrCL (mL/min) = \[(140-age) × weight (kg) × f \]/(SCR (mg/dL) × 72) F = 0.85; SCR = serum creatinine. II. Urine protein \< 2 + or 24 h (h) urine protein quantification \< 1.0 g.
• C) liver:
• I. Serum total bilirubin (TBil)≤1.5 × ULN II. AST and ALT ≤2.5 × ULN III. Alb (Alb)≥28GL

You may not qualify if:

• Ovarian cancer of non-epithelial origin, fallopian tube cancer, primary peritoneal cancer (such as germ cell tumors) , and low-malignant potential ovarian tumors (such as borderline tumors) .
• Previous (within 5 years) or concurrent with other malignancies, the local tumors that have been cured (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer that has not recurred for more than 3 years after radical operation are excluded.
• Local recurrence is suitable for patients undergoing surgery.
• Previous radiation therapy of the abdomen and pelvis.
• Had received immunotherapy in the past, these include immune-checkpoint inhibitors (such as PD-1 CTLA-4 Bispecific monoclonal antibody, which allow previous use of PD-1 or PD-L1 mabs) , immune-checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.) , and immune-cell therapies for any of the mechanisms of tumor immunity.
• Patients who were known to be allergic to any component of any investigational drug, had a history of severe hypersensitivity to other monoclonal antibody, and were known to have permanently discontinued the relevant therapeutic drug could not be enrolled.
• Participated in the treatment of an experimental drug or used an experimental device within 4 weeks before the first study administration.
• One week before the first dose (or 5 drug half-lives, whichever is longer) , a potent or intermediate CYP3A4 inhibitor, a P-gp or a BCRP inhibitor were received.
• Last systemic anti-tumor therapy, including chemotherapy, bevacizumab or its bioanalogues, was given within 3 weeks before the first dose, and anti-tumor hormone therapy was given within 2 weeks before the first dose Non-target lesions were treated with palliative local therapy within 2 weeks before the first dose Received Hapten therapy (such as interleukin, interferon, and thymosin, not including Il-11 for thrombocytopenia) within 2 weeks before the first dose; Within 1 week before the first administration, she had received Chinese herbal medicine or Chinese patent medicine with anti-tumor indication.
• Use of systemic glucocorticoid or other immunosuppressive drug within one week prior to initial administration, systemic glucocorticoid (i.e. not more than 10mg daily prednisone or equivalent dose of other glucocorticoid) that do not include nasal spray, inhalation or other route local glucocorticoid or physiological doses, allow for symptoms of dyspnea due to diseases such as chronic obstructive pulmonary disease, and temporary use of glucocorticoid for allergy prevention.
• The live vaccine was administered within 30 days of the first dose, or was planned for the duration of the study.
• Has an active autoimmune disease that requires systemic treatment in the past two years (such as use of disease-modifying drugs, corticosteroid, immunosuppressive therapy) , replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency) is not considered a systemic treatment.
• Active or previous history of a well-defined inflammatory bowel disease such as Crohn's disease, ulcerative colitis or chronic diarrhea.
• History of immunodeficiency, HIV antibody positive, current long-term use of systemic corticosteroid or other immunosuppressive agents.
• Subjects with known active tuberculosis (TB) and suspected active TB should be excluded by clinical examination.

Sponsors & Collaborators

• West China Second University Hospital: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Rutie Yin, Dr.

CONTACT

+86 135 6897 5969; yrtt2013@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of chemoradiotherapy department

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 19, 2024
• Study Start: July 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07