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Platinum-resistant Recurrent Ovarian CancerPhase 2NCT06509971

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

A Phase 2 study testing QL1706 in people with Platinum-resistant Recurrent Ovarian Cancer, run by West China Second University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
QL1706
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
No sites listed yet
Study dates
Jul 2024to Jun 2026
Phase
Phase 2
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • hematology (no blood component and cell growth factor support therapy was used for 7 days before study initiation) :
  • 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.
  • kidneys:
  • 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.
  • liver:
  • Serum total bilirubin (TBil)≤1.5 × ULN II. AST and ALT ≤2.5 × ULN III. Alb (Alb)≥28GL
  • coagulation function:
  • International standard ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 × ULN.
  • cardiac function:
  • Left ventricular ejection fraction (LVEF)≥50% .
  • A fertile female subject must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result can not be confirmed as negative, a serum pregnancy test is required, whichever is the serum pregnancy result) , and the results were negative. If a fertile female subject has sex with an unsterilized male partner, the subject must use an acceptable method of contraception from the beginning of the screening process, consent must also be given to the method of contraception used prior to its continued use for 120 days after the last administration of the study drug; discontinuation of contraception after this time point should be discussed with the investigator.
  • Subjects were willing and able to comply with schedule visits, treatment protocols, laboratory tests, and other requirements of the study.

Who cannot join

  • 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.
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  • 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.
  • Known active syphilis infection.
  • Known history of organ transplants and Hematopoietic stem cell transplants.
  • Previous history of non-infectious pneumoniainterstitial lung disease requiring systemic glucocorticoid therapy or current presence of non-infectious pneumonia.
  • Severe infection occurred within 4 weeks before the first dose, including but not limited to complications, sepsis, or severe pneumonia requiring hospitalization; Active infection (excluding antiviral therapy for hepatitis B or C) that has received systemic anti-infective therapy within 2 weeks before the first dose.
  • Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA > 1000 copies/ml (200 IU/ml or above the lower limit of detection, whichever is higher) were required to receive anti-hbv therapy during study treatment for those with hepatitis B; and active hepatitis C subjects (HCV antibody positive and HCV-rna levels above the lower limit of detection) .
  • Those who had a major surgical procedure or major trauma within 30 days before the first dose, or who had a major surgical plan within 30 days after the first dose (at the investigator's discretion) ; Minor local procedures (excluding central venous catheterization via peripheral venipuncture and intravenous port implantation) were performed within 3 days before the first dose.
  • Known presence of central nervous system metastases, meningeal metastases, spinal cord metastases or compression.
  • Subjects with clinical symptoms or repeated drainage of pleural effusion, pericardial effusion, or ascites.
  • There are currently uncontrolled co-morbidities, these include, but are not limited to, symptomatic heart failure (grade 2 or higher according to the New York Heart Association functional class) , unstable angina, acute myocardial ischemia, poorly controlled arrhythmias, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease, or gastritis, psychiatric/social conditions that may limit subjects' ability to comply with research requirements or affect their ability to provide written informed consent.
  • Uncontrolled hypertension, systolic blood pressure > 140 mmhg or diastolic blood pressure > 90 mmhg after optimal medical treatment, history of Hypertensive crisis or hypertensive encephalopathy.
  • Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, heart failure or vascular disease (such as a ruptured aortic aneurysm) that requires hospitalization within 12 months of the first dose, or other cardiac lesions (such as poorly controlled arrhythmias, myocardial ischemia) that may affect the safety evaluation of the study drug.
  • Esophageal Gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive bowel resection (partial or extensive colectomy with chronic diarrhea) , Crohn's disease, ulcerative colitis or chronic diarrhea.
  • Any arterial thromboembolic event, NCI CTCAE version 5.0 Grade 3 or greater, venous thromboembolism, transient cerebral ischemia, or cerebrovascular accident occurred within 6 months before the first dose.
  • Acute exacerbation of chronic obstructive pulmonary disease within 1 month of first dose.
  • Patients with any sign of bleeding constitution, regardless of severity; patients with any bleeding or bleeding event ≥ CTCAE grade 3 within 4 weeks before the first dose.
  • Current imaging or clinical manifestations of gastrointestinal obstruction, including incomplete obstruction.
  • Severe bleeding tendency or Coagulopathy, or receiving thrombolytic therapy. Aspirin (> 325mg daily) or dipyrimidine, ticlopidine, clopidogrel, and Cilostazol are currently used or have been used recently (within 10 days before the first dose of study treatment) , and anticoagulants that require monitoring of INR (such as Warfarin) .
  • Imaging showed that the tumor had surrounded or invaded important blood vessels, or that it was highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study, compression of the superior vena cava, inferior vena cava or invasion of the heart.
  • Toxicities from previous antitumour therapy did not resolve, defined as toxicities that did not return to grade 0 or 1 of NCI CTCAE version 5.0, or levels specified in the inclusion/exclusion criteria; Except for alopecia and sequelae of neurotoxicity related to previous platinum therapy. For subjects who develop irreversible toxicity and are not expected to worsen after administration of the study drug (EG, hearing loss) , it may be included in the study after consultation with the medical examiner.
  • Local or systemic disease caused by a non-malignant tumor, or disease or symptoms secondary to the tumor, and can lead to higher medical risk and/or uncertainty in the evaluation of survival; Such as leukemoid reaction cancer (white blood cell count > 20 × 10 ^ 9 L) , cachexia (known as weight loss of more than 10% 3 months before screening) , etc. .
  • Known history of mental illness, substance abuse, alcohol or drug abuse.
  • Women who are pregnant or nursing. The presence of any disease, treatment, or laboratory abnormality in the past or present may confuse the results of the study, affect the participant's participation in the study, or may not be in the best interest of the participant.

Trial locations and contacts

No sites are listed yet.

Rutie Yin, Dr. contact

+86 135 6897 5969

yrtt2013@163.com

About this study

  • 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.

Read the detailed description

The efficacy of chemotherapy combined with anti-angiogenic agents in the treatment of platinum-resistant recurrent ovarian cancer has been demonstrated in clinical studies, and QL1706 acts as a bi-functional combination antibody that blocks both PD-1 and CTLA-4, in other cancer trials that have been conducted, it is expected that better efficacy and adverse event rates comparable to those of anti-PD-1 mabs and anti-CTLA-4 mabs will be achieved with combination chemotherapy and anti-angiogenic drugs, it may be possible to obtain better anti-tumor effects in platinum-resistant recurrent ovarian cancer patients.

Being tested
QL1706

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706Drug

    Also called bevacizumab, albumin-binding paclitaxel

    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.

Study groups in NCT06509971
Study groupRoleWhat they receive
Experimental ArmExperimentalQL1706: 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.
Receives: Drug: QL1706

What is being measured

The primary outcome is the main question the study is designed to answer.

  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) .

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509971
Sponsor's protocol ID
WCSUH20240707
Status last verified
Jul 2024
First submitted
7 Jul 2024
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 in people with Platinum-resistant Recurrent Ovarian Cancer, run by West China Second University Hospital.

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 21 inclusion and 37 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 19 Jul 2024. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Rutie Yin, Dr. (+86 135 6897 5969, yrtt2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 6 months). 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 NCT06509971.

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 19 Jul 2024.

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