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Ovarian Clear Cell CarcinomaPhase 3INVIGORATENCT07002346

INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma

A Phase 3 study testing QL1706 (bispecific antibody targeting PD-1 and CTLA-4), Bevacizumab and carboplatin in people with Ovarian Clear Cell Carcinoma, run by Tongji Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to <75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Clear Cell Carcinoma
What is being tested?
QL1706 (bispecific antibody targeting PD-1 and CTLA-4), Bevacizumab and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteChina
Study dates
15 Nov 2025to 1 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Voluntary participation in the study and signed informed consent form.
  • Age ≥ 18 years and < 75 years, female.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival ≥ 3 months.
  • Histologically or cytologically newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma.
  • Patients are planned to undergo primary debulking surgery (PDS), regardless of whether satisfactory debulking is achieved, and have complete surgical records and residual disease assessment results (R0 vs R1/R2).
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  • No prior first-line postoperative systemic antitumor therapy for the current ovarian clear cell carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc.
  • Adequate organ function confirmed by the following requirements:
  • Hematological (no use of any blood components or cell growth factors within 7 days prior to initiation of study treatment):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1,500/mm^3). ii. Platelet count ≥ 100 × 10^9/L (100,000/mm^3). iii. Hemoglobin ≥ 90 g/L.
  • Renal:
  • Calculated creatinine clearance (CrCl) ≥ 50 mL/min. CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = [(140 - age) × weight (kg) × F] / [SCr (mg/dL) × 72], where F = 0.85 for females and SCr = serum creatinine.
  • Urine protein < 2+ or 24-hour quantitative urine protein < 1.0 g.
  • Hepatic:
  • Total serum bilirubin (TBil) ≤ 1.5 × ULN. ii. AST and ALT ≤ 2.5 × ULN.
  • Coagulation:
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • For women of childbearing potential, a negative serum or urine pregnancy test within one week prior to enrollment, and effective contraceptive measures must be used after enrollment, for example, use of physical barrier contraception (condoms) or complete abstinence. Oral, injectable, or implantable hormonal contraceptives are not permitted. Or, women of non-childbearing potential, defined as: i. Naturally postmenopausal for at least 1 year. ii. Surgically sterile, including bilateral oophorectomy, bilateral salpingectomy, or hysterectomy.
  • Serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels within the postmenopausal range for the study center's laboratory.
  • Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.
  • Patient is willing to cooperate in completing quality of life questionnaires during the trial treatment and follow-up period, and agrees that these questionnaire results can be used for clinical research.

Who cannot join

  • Histologically confirmed ovarian cancer of other epithelial origin or non-epithelial origin, other than ovarian clear cell carcinoma; ovarian tumors of low malignant potential, such as borderline tumors.
  • Prior systemic preoperative antitumor therapy for the current ovarian clear cell carcinoma, including but not limited to neoadjuvant chemotherapy (NACT) or other types of neoadjuvant therapy, or planned neoadjuvant therapy followed by interval debulking surgery (IDS) during screening.
  • Prior treatment with immune checkpoint inhibitors, such as PD-1/PD-L1 antibodies, or drugs targeting other T-cell receptors, such as CTLA-4, as well as immune checkpoint agonist antibodies, such as anti-ICOS, CD40, CD137, GITR, or OX40 antibodies, and immune cell therapy.
  • Systemic use of corticosteroids or other immunosuppressive drugs, such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or TNFα inhibitors, within 2 weeks before the first dose. Note: Inhaled or topical steroids, steroids as premedication for hypersensitivity reactions, such as CT scan contrast agent premedication or cytotoxic chemotherapy premedication, or adrenal replacement steroids, daily ≤10 mg prednisone or equivalent, are permitted in the absence of active autoimmune disease.
  • Prior, within 5 years, or concurrent malignancies, with the exception of cured local tumors, 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 with no recurrence >3 years after radical surgery.
  • Patients with contraindications to bevacizumab, including but not limited to prior gastrointestinal perforation, surgery within 28 days before medication or incompletely healed wounds, severe bleeding or recent hemoptysis, or other situations where the investigator deems bevacizumab unsuitable.
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  • Receipt of live vaccine within 30 days before the first dose of study treatment, persisting until 90 days after the last dose of study treatment. Note: Live vaccines include but are not limited to measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza virus vaccines not containing live virus, inactivated COVID-19 vaccines, etc., are permitted.
  • Active autoimmune disease requiring systemic treatment, such as use of disease-modifying drugs, corticosteroids, or immunosuppressants, within 2 years before the first dose. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, are not considered systemic treatment. Note: Patients with cataracts, Graves' disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded.
  • Systemic infection requiring systemic antibiotic treatment or other severe infections within 2 weeks before randomization, or unexplained fever >38.0°C during the screening period or before enrollment, and inability to discontinue aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for more than 5 days.
  • Severe illness or concomitant non-tumor diseases, such as neurological disorders, psychiatric disorders, infectious diseases, or laboratory abnormalities, that may increase the risk of participating in the study or taking study drugs, and which the investigator deems would make the patient unsuitable for the study.
  • Pregnant or lactating women.
  • Clinically significant cardiovascular diseases, including but not limited to:
  • Myocardial infarction or unstable angina within 6 months before the first dose.
  • Stroke or transient ischemic attack within 6 months before the first dose.
  • Hypertension not controlled by optimal antihypertensive therapy, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
  • Poorly controlled arrhythmias. Patients who have stabilized before the first dose and have been stable for ≥14 days may be enrolled.
  • Congestive heart failure, New York Heart Association (NYHA) functional class II-IV.
  • Myocarditis.
  • Expectation of needing any other form of anti-tumor therapy during the study period.
  • Receipt of traditional Chinese medicines with anti-tumor indications or immunomodulatory drugs, including but not limited to thymosin, interferon, interleukin-2, etc., within 2 weeks before the first dose.
  • HIV-positive patients.
  • Known history of anti-tuberculosis treatment within one year before the first administration of study treatment.
  • Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥2000 IU/mL or 10^4 copies/mL; HCV antibody positive and HCV RNA positive.
  • Pre-existing peripheral neuropathy of grade ≥2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  • Current or recent, within 10 days before the first dose of study drug, continuous use of full-dose oral or parenteral anticoagulants or thrombolytic agents for 10 days. Note: Prophylactic use of low-dose anticoagulants is permitted, including low-dose warfarin (≤1 mg/day), low-dose heparin (≤12,000 U/day), or low-dose aspirin (≤100 mg/day), provided the prothrombin time international normalized ratio (INR) is ≤1.5.
  • Hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis, or imaging showing tumor invasion/infiltration of major blood vessels, or investigator or radiologist assessment of bleeding tendency.
  • Known history of severe allergy to macromolecular protein preparations, or to any component of QL1706 or other investigational drugs, or severe allergic history to chemotherapeutic drugs such as carboplatin, paclitaxel, nab-paclitaxel, or their premedications.
  • Currently participating in interventional clinical research treatment, or receiving any other investigational drug or research device treatment within 4 weeks before the first dose. Patients who failed screening for other clinical trials may be included in this study.
  • Patients deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430000

    Qinglei Gao, Doctor, +86-27-83662681, qingleigao@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Trial Evaluating QL1706 With Bevacizumab Versus Standard Platinum-Based Chemotherapy With or Without Bevacizumab as First-line Treatment for Advanced Ovarian Clear Cell Carcinoma

The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to <75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are:

  1. Does QL1706 plus bevacizumab, compared with standard platinum-based chemotherapy with or without bevacizumab, prolong patients' progression-free survival (PFS)?
  2. What is the safety profile of QL1706 followed by QL1706 plus bevacizumab, such as what medical problems (adverse events) do participants experience?
Read more

Researchers will compare QL1706 followed by QL1706 plus bevacizumab (experimental arm) with standard platinum-based chemotherapy consisting of paclitaxel plus carboplatin with or without bevacizumab (control arm) to see whether QL1706-based immunotherapy is more effective in the first-line treatment of advanced ovarian clear cell carcinoma.

Participants will:

  1. Be randomly assigned to receive either QL1706 alone during Cycle 1 followed by QL1706 plus bevacizumab from Cycle 2, or paclitaxel plus carboplatin with or without bevacizumab according to prespecified high-risk criteria.
  2. Visit the research center regularly for drug infusions, medical examinations (such as vital signs, physical exams, laboratory tests), and tumor imaging assessments.
  3. Complete quality of life questionnaires as required.
Being tested
QL1706 (bispecific antibody targeting PD-1 and CTLA-4), Bevacizumab, carboplatin, Paclitaxel
Keywords
Ovarian Clear Cell Carcinoma, QL1706, Bevacizumab, First-line treatment, Immunotherapy

What participants receive

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

  • QL1706 (bispecific antibody targeting PD-1 and CTLA-4)Drug

    QL1706: 5 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 2 years.

  • BevacizumabDrug

    Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 22 cycles.

  • carboplatinDrug

    Carboplatin: AUC=5, intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 6 cycles

  • PaclitaxelDrug

    Paclitaxel: 175 mg/m^2 intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 6 cycles

Study groups in NCT07002346
Study groupRoleWhat they receive
Experimental Arm: QL1706 + BevacizumabExperimentalQL1706 5 mg/kg Q3W (D1)+Bevacizumab 15mg/kg Q3W (D1) (QL1706/Bevacizumab treatment for a maximum of 2 years/22 cycles)
Receives: Drug: QL1706 (bispecific antibody targeting PD-1 and CTLA-4); Drug: Bevacizumab
Control Arm: Paclitaxel + Carboplatin ± BevacizumabActive comparatorPaclitaxel 175 mg/m² Q3W (D1) + Carboplatin AUC 5 Q3W (D1), for 6 cycles, with or without Bevacizumab 15 mg/kg Q3W (D1) according to prespecified high-risk criteria. Bevacizumab may be continued until disease progression, unacceptable toxicity, or completion of a maximum of 22 cycles.
Receives: Drug: Bevacizumab; Drug: carboplatin; Drug: Paclitaxel

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented radiographic disease progression according to RECIST v1.1 as assessed by blinded independent central review (BICR), or death from any cause, whichever occurs first.

    Measured: Up to 4 years

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause.

    Measured: Up to 4 years

  2. Progression-Free Survival 2 (PFS2)

    Defined as the time from randomization to the second disease progression or death (whichever occurs first).

    Measured: Up to 4 years

  3. Time to First Subsequent Therapy (TFST)

    Defined as the time from the randomization date to the start date of the first subsequent anti-tumor therapy.

    Measured: Up to 4 years

  4. Time to Second Subsequent Therapy (TSST)

    Defined as the time from the randomization date to the start date of the second subsequent anti-tumor therapy.

    Measured: Up to 4 years

  5. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Safety includes the adverse event profile of all drugs included according to the Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 4 years

Timeline

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

  1. First posted3 Jun 2025
  2. Study start15 Nov 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002346
Sponsor's protocol ID
2025-TJ-OCCC
Acronym
INVIGORATE
Status last verified
May 2026
First submitted
20 May 2025
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QL1706 (bispecific antibody targeting PD-1 and CTLA-4), Bevacizumab and carboplatin in people with Ovarian Clear Cell Carcinoma, run by Tongji Hospital at 1 site 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 21 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to 4 years). 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 NCT07002346.

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 18 May 2026.

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