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Ovarian CancerPhase 2BRIGHTNCT05044871

Biomarker-driven Targeted Therapy in Patients With Recurrent Platinum-resistant Epithelial Ovarian Cancer

A Phase 2 study testing Pamiparib, Bevacizumab and Tislelizumab in people with Ovarian Cancer, run by Tongji Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an open-label, multicenter, umbrella study aimed to evaluate the combined, biomarker-driven, targeted treatment efficiency of Pamiparib, Bevacizumab, Tislelizumab, and Nab-paclitaxel in patients with platinum-resistant recurrent ovarian cancer (PROC). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Pamiparib, Bevacizumab and Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
22 Jul 2022to 17 Feb 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation and signing of informed consent
  • Age ≥ 18 years;
  • the Eastern United States cancer cooperation group (ECoG) score 0-1;
  • Platinum-resistant recurrent ovarian cancer (PROC): the patient was diagnosed with platinum-resistant recurrence for the first time. PROC refers to the disease progression that occurred < 6 months after the last dose of platinum-based chemotherapy. Imaging-based evaluation for the latest recurrence/progression before enrollment was required;
  • Malignant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histology or cytology, including high-grade serous cancer, low-grade serous cancer, endometrioid cancer, clear cell cancer, mucinous cancer, and carcinosarcoma;
  • Biomarker detection and tumor sample collection meet the following standards:
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  • Patients must provide archived tumor tissue samples (formalin-fixed, paraffin-embedded tumor tissue blocks [preferred], or at least 10 unstained tissue sections), except for patients with serous carcinoma, endometrioid carcinoma, clear cell carcinoma and gBRCAm
  • If the patient has been tested for BRCA1 / 2 gene in the past, only the corresponding test report needs to be provided
  • Sufficient organ functions, which is defined as:
  • neutrophil absolute value (ANC) ≥ 1.5 × 109/L
  • platelet count (PLT) ≥ 75 × 10*9/L
  • hemoglobin ≥ 9 g / dl
  • serum creatinine CR < 1.5 × Upper normal value (ULN)
  • total serum bilirubin ≤ 1.5 × Upper normal range (ULN)
  • both aspartate aminotransferase and alanine aminotransferase ≤ 3 × ULN
  • coagulation function: international normalized ratio (INR) ≤ 1.5; Activated partial prothrombin time (APTT) ≤ 1.5 × ULN
  • Patients must have lesions that can be measured according to RECIST v1.1 standard;
  • Participants were allowed to have previously VEGF / VEGFR inhibitors treatment;
  • Participants were allowed to have previously PARP inhibitors treatment. However, for treatment arm 1 (arm1), the exposure time of PARP inhibitors should ≥ 12 months after first-line chemotherapy or ≥ 6 months after second-line and above chemotherapy;
  • Life expectancy ≥ 3 months;

Who cannot join

  • The exclusion criteria of bevacizumab were clinically significant cardiovascular and cerebrovascular diseases, history of abdominal fistula or gastrointestinal perforation, acute intestinal obstruction or sub obstruction, and active bleeding;
  • Uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) or clinically significant (active) cardiovascular disease: cerebrovascular accident (CVA) / stroke ≤ 6 months from the treatment of the first clinical study; Myocardial infarction ≤ 6 months from the first clinical study treatment; Unstable angina pectoris; Congestive heart failure (CHF) of grade II or above in the cardiac function classification standard of the New York Heart Association (NYHA); Serious arrhythmias requiring treatment;
  • Previous medical history showed newly discovered thrombotic diseases within 6 months before or during the screening period; Patients with severe wound nonunion, ulcer, or fracture;
  • Major surgery within 30 days before the first administration of study treatment; Patients expected to have invasive surgery during treatment;
  • Patients with other malignant tumors;
  • Patients who have previously received anti-programmed cell death protein-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1) or anti-PD-L2 drugs, or another drug treatment for T cell inhibitory receptors (e.g., cytotoxic T lymphocyte-associated antigen-4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (tnfrsf9)];
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  • Active autoimmune diseases requiring systemic treatment in the past 2 years;
  • Any case requiring systemic treatment with corticosteroids (prednisone or equivalent > 10 mg/day) or other immunosuppressive drugs ≤ 14 days before the first administration of the study drug;
  • Known history of human immunodeficiency virus (HIV) infection;
  • Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA > 500 IU / ml) or active HCV carriers with detectable HCV RNA; Note: inactive hepatitis B surface antigen (HBsAg) carriers and treated and stable hepatitis B patients (HBV DNA < 500 IU / ml) can be included in the group;
  • History of interstitial lung disease, noninfectious pneumonia, or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc;
  • Previous heterologous stem cell transplantation or organ transplantation;
  • Peripheral neuropathy ≥ grade 2;
  • Foods or drugs that are expected to use CYP3A4 strong inducers or strong inhibitors within 28 days before the use of the study drug;
  • Participate in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or is in the follow-up period of intervention study;
  • Women of childbearing age who are unwilling or unable to use effective methods for contraception during the whole treatment period of this trial and within 6 months after the last administration of the study drug [women of childbearing age include: any women who have had menarche and have not undergone successful artificial sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or premenopausal], pregnant or lactating women.
  • Other conditions judged by the researcher that do not meet the enrollment requirements.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: The Efficiency of Biomarker-driven Targeted Therapy in Patients With Recurrent Platinum-resistant Epithelial Ovarian Cancer (PROC): An Umbrella Study

This study is an open-label, multicenter, umbrella study aimed to evaluate the combined, biomarker-driven, targeted treatment efficiency of Pamiparib, Bevacizumab, Tislelizumab, and Nab-paclitaxel in patients with platinum-resistant recurrent ovarian cancer (PROC).

Read the detailed description

BRCA1/2 gene status and CD8+ tumor-infiltrating T cell count (CD8 + TILs count) were evaluated as biomarkers using archived tumor tissue samples. Treatment arms were arranged according to pathological diagnosis and biomarker detection results.

Arm1 (Biomarkers: BRCA 1/2 mutant): Pamiparib 40mg PO. bid. plus Bevacizumab 7.5mg/kg IV. D1 (q3w.).

Arm2 (Biomarkers: BRCA 1/2 wildtype and ≥3 CD8+ TILs count): Tislelizumab 200mg IV. D1 + Bevacizumab 7.5mg/kg IV. D1 + Nab-paclitaxel 125mg / m2 IV. D1, 8 (q3w).

Arm3 (Biomarkers: BRCA 1/2 wildtype and <3 CD8+ TILs count): Bevacizumab 7.5mg/kg IV D1, 15 + Nab-paclitaxel 100mg / m2 IV D1, 8, 15 (Q4w).

Treatment would continue until disease progression, intolerable toxicity, death, withdrawal of consent, or sponsor termination of the study, whichever occurs first.

Conditions
Ovarian Cancer
Being tested
Pamiparib, Bevacizumab, Tislelizumab, Nab paclitaxel, Bevacizumab + Nab paclitaxel (intense dose-dense)
Keywords
Biomarker-driven, Targeted therapy, Immunotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • PamiparibDrug

    40mg PO. bid.

  • BevacizumabDrug

    7.5mg/kg IV. D1 (q3w.)

  • TislelizumabDrug

    200mg IV. D1

  • Nab paclitaxelDrug

    125mg / m2 IV. D1, 8 (q3w).

  • Bevacizumab + Nab paclitaxel (intense dose-dense)Drug

    Bevacizumab 7.5mg/kg IV. D1, 15 (Q4w). + Nab paclitaxel 100mg / m2 IV. D1, 8, 15 (Q4w).

Study groups in NCT05044871
Study groupRoleWhat they receive
Arm 1: Pamiparib+ BevacizumabExperimentalArm1 (Biomarkers: BRCA 1/2 mutant): Pamiparib 40mg PO. bid. plus Bevacizumab 7.5mg/kg IV. D1 (q3w.).
Receives: Drug: Pamiparib; Drug: Bevacizumab
Arm 2: Tislelizumab + Bevacizumab + Nab-paclitaxelExperimentalArm2 (Biomarkers: BRCA 1/2 wildtype and ≥3 CD8+ TILs count): Tislelizumab 200mg IV. D1 + Bevacizumab 7.5mg/kg IV. D1 + Nab-paclitaxel 125mg / m2 IV. D1, 8 (q3w).
Receives: Drug: Bevacizumab; Drug: Tislelizumab; Drug: Nab paclitaxel
Arm 3: Bevacizumab + Nab-paclitaxelExperimentalArm3 (Biomarkers: BRCA 1/2 wildtype and <3 CD8+ TILs count): Bevacizumab 7.5mg/kg IV D1, 15 + Nab-paclitaxel 100mg / m2 IV D1, 8, 15 (Q4w).
Receives: Drug: Bevacizumab + Nab paclitaxel (intense dose-dense)

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS is defined as the time from enrollment to the first imaging disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.

    Measured: Up to 3 years

  2. Overall survival (OS)

    OS is defined as the time between enrollment and the patient's death due to any cause.

    Measured: Up to 5 years

  3. Disease control rate (DCR)

    DCR is defined as the proportion of the patients with complete response, partial remission, and stable disease after treatment. Assessed according to RECIST v1.1 by investigator.

    Measured: Up to 5 years

  4. Duration of remission (DOR)

    DOR is defined as the time interval from the first record of disease response to disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.

    Measured: Up to 3 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 5 years

Timeline

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

  1. First posted16 Sep 2021
  2. Study start22 Jul 2022
  3. Primary completion17 Feb 2025
  4. Study completion17 Feb 2025

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05044871
Sponsor's protocol ID
2021-TJ-PROC
Acronym
BRIGHT
Status last verified
Jun 2025
First submitted
9 Sep 2021
Last updated
8 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xu Y, Xiong F, Li H, Zheng H, Jiang J, Li Q, Li G, Zhao W, Li R, Li J, Xie R, An R, Zhang H, Gao Q. Biomarker-driven targeted therapy in patients with recurrent platinum-resistant epithelial ovarian cancer (BRIGHT): protocol for an open-label, multicenter, umbrella study. Int J Gynecol Cancer. 2024 Sep 2;34(9):1461-1465. doi: 10.1136/ijgc-2024-005351.

    PubMed 38658024

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pamiparib, Bevacizumab and Tislelizumab in people with Ovarian Cancer, 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 20 inclusion and 17 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: finished, as of the sponsor's last update on 8 Jun 2025. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 3 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 NCT05044871, which also lists 1 linked publication.

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 8 Jun 2025.

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