Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma

NCT04735861 | Completed Phase 2

• 1 other identifier: 2021-TJ-OCCC
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian clear cell carcinoma (OCCC) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. Previous studies indicate that both bevacizumab and PD-1 inhibitor have clinical benefits for OCCC patients. And the combination of bevacizumab and PD-1 inhibitor has shown preliminary safety and clinical activity. Therefore, this study aims to investigate the potential benefit of combination therapy for patients with OCCC.

Conditions

Ovarian Clear Cell Carcinoma

Keywords

Ovarian clear cell carcinoma; PD-1 inhibitor; Antiangiogenic therapy

Outcome Measures

Primary Outcomes (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.

  Up to 3 years

Secondary Outcomes (7)

• Progression-free survival (PFS)

  Up to 3 years

• Time to response (TTR)

  Up to 2 years

• Duration of remission (DOR)

  Up to 3 years

• Disease control rate (DCR)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

Study Arms (1)

Combination Arm

EXPERIMENTAL

Sintilimab 200mg iv., q3w, up to 2 years; Bevacizumab 15mg/kg iv., q3w, up to 22 cycles. Treatment is given until confirmed progression, death, unacceptable toxicity, or any other protocol-specified criterion for withdrawal, whichever occurs first.

Drug: Sintilimab; Drug: Bevacizumab Biosimilar IBI305

Interventions

Sintilimab DRUG

Sintilimab 200mg iv. q3w, up to 2 years.

Also known as: IBI308

Combination Arm

Bevacizumab Biosimilar IBI305 DRUG

Bevacizumab 15mg/kg iv. q3w, up to 22 cycles

Also known as: IBI305

Combination Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with age ≥ 18 years old and \< 75 years old.
• There must be a histological diagnosis of ovarian clear cell carcinoma. For tumors with mixed histology, at least 70% of the tumors are composed of clear cell carcinoma.
• Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
• Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
• According to the definition of RECIST1.1, the patient must have measurable lesions. Measurable lesions are defined as:
• There is at least one lesion that can be accurately measured in at least one dimension;
• When measured by CT or MRI or the diameter gauge of clinical examination, each lesion must be ≥ 10 mm. When measured by chest X-ray, each lesion must be ≥ 20 mm.
• When lymph nodes measured by CT or MRI, the short axis of the lymph nodes must be ≥ 15 mm.
• It must be at least 4 weeks away from the last anti-tumor treatment before starting the trial treatment.
• No administration of immune checkpoint inhibitors before.
• Enough archived tumor tissue blocks (or at least 10 freshly cut unstained glass slides) provided for analysis.
• ECOG performance status score ≤ 2.
• Expected survival time \> 12 weeks.
• Adequate hematology and organ function, including:
• hemoglobin \> 9 g/dL without blood transfusion or erythropoietin in the past 14 days.

You may not qualify if:

• Personnel involved in the formulation or implementation of research plans.
• Histological evidence of non-ovarian clear cell carcinoma.
• Lack of tumor samples (archived and/or recently obtained).
• Previous administration of the following therapies in the past: anti-PD-1/PD-L1/PD-L2 drugs; or anti stimulating/synergistic inhibition of T cell receptor (for example, CTLA-4, CD134, CD137) drugs.
• Patients with contraindications of bevacizumab, including but not limited to: previous gastrointestinal perforation, receiving surgery or having incomplete-healing wound within 28 days before administration of combination therapy, severe bleeding or recent hemoptysis, and other circumstances that are inappropriate for bevacizumab according to physician's assessment.
• Patients are known to be allergic to the active ingredients or excipients of sintilimab or bevacizumab.
• Symptomatic or uncontrolled brain metastases that require simultaneous treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical manifestations of spinal cord compression.
• Currently participating in interventional clinical research treatment, or received other research drugs or used research equipment treatment within 4 weeks before the first administration.
• Diagnosis of other malignant diseases other than ovarian cancer within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ).
• An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatments a.
• Active hemoptysis (at least 2.5ml or 1/2 teaspoon of blood was spit out at a time) within 3 months before the first administration.
• Patients have been vaccinated with live vaccine within 1 month before the first administrationb.
• Patients have received platelet or red blood cell transfusion within 4 weeks before the first administration.
• Patients receive major surgery within 4 weeks before the first administration (except for surgery for the purpose of biopsy) or expect major surgery during the study period.
• Patient have received systemic treatment with anti-tumor Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration.

Sponsors & Collaborators

• Tongji Hospital: lead
• Union Hospital affiliated to Tongji Medical College: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Henan Cancer Hospital: collaborator
• Hubei Cancer Hospital: collaborator
• Shengjing Hospital: collaborator
• Anhui Provincial Cancer Hospital: collaborator
• Zhongnan Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• The First People's Hospital of Jingzhou: collaborator
• Xiangyang Central Hospital: collaborator
• Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (2)

• Peng Z, Li H, Gao Y, Sun L, Jiang J, Xia B, Huang Y, Zhang Y, Xia Y, Zhang Y, Shen Y, Huang B, Nie J, Chen X, Liu X, Feng C, Li Z, Zhang W, Tao K, Zhang Q, Duan S, Chen Y, Chen Y, Wang W, Zheng H, Lu Y, Liu Y, Wang L, Qi W, He Y, Tian Y; NUWA Platform Research Group; Li G, Ma D, Gao Q. Sintilimab combined with bevacizumab in relapsed or persistent ovarian clear cell carcinoma (INOVA): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Oct;25(10):1288-1297. doi: 10.1016/S1470-2045(24)00437-6. Epub 2024 Sep 11.

  PMID: 39276785 DERIVED

• Li R, Liu X, Song C, Zhang W, Liu J, Jiao X, Yu Y, Zeng S, Chi J, Zhao Y, Ma G, Huo Y, Li M, Peng Z, Li G, Jiang J, Gao QL. Sintilimab combined with bevacizumab in relapsed/persistent ovarian clear cell carcinoma (INOVA): an investigator-initiated, multicentre clinical trial-a study protocol of clinical trial. BMJ Open. 2022 May 24;12(5):e058132. doi: 10.1136/bmjopen-2021-058132.

  PMID: 35613822 DERIVED

MeSH Terms

Interventions

sintilimab

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: Professor

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: April 7, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available immediately following publication without end date.
• Access Criteria: To obtain the data, data requestors will need to sign a data access agreement.

Locations

CN (1)