Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA)

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ClinicalTrials.gov Identifier: NCT04735861

Recruitment Status : Recruiting

First Posted : February 3, 2021

Last Update Posted : October 14, 2021

See Contacts and Locations

Sponsor:

Collaborators:

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Qilu Hospital of Shandong University

The First Affiliated Hospital of Zhengzhou University

Henan Cancer Hospital

Hubei Cancer Hospital

Shengjing Hospital

Anhui Provincial Cancer Hospital

Wuhan University

Jingzhou Central Hospital

The First People's Hospital of Jingzhou

Xiangyang Central Hospital

Information provided by (Responsible Party):

Qinglei Gao, Tongji Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Clear Cell Carcinoma	Drug: Sintilimab Drug: Bevacizumab Biosimilar IBI305	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	38 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Sintilimab Plus Bevacizumab in Patients With Recurrent/Persistent Ovarian Clear Cell Carcinoma
Actual Study Start Date :	February 1, 2021
Estimated Primary Completion Date :	December 31, 2022
Estimated Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Genetic and Rare Diseases Information Center resources: Epithelial-myoepithelial Carcinoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Combination Arm 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 Sintilimab 200mg iv. q3w, up to 2 years. Other Name: IBI308 Drug: Bevacizumab Biosimilar IBI305 Bevacizumab 15mg/kg iv. q3w, up to 22 cycles Other Name: IBI305

Outcome Measures

Primary Outcome Measures :

Objective response rate (ORR) [ Time Frame: Up to 3 years ]
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.

Secondary Outcome Measures :

Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
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.
Time to response (TTR) [ Time Frame: Up to 2 years ]
TTR is defined as the time from the first administration to the first CR or PR recorded. Assessed according to RECIST v1.1 by investigator.
Duration of remission (DOR) [ Time Frame: Up to 3 years ]
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.
Disease control rate (DCR) [ Time Frame: Up to 5 years ]
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.
Overall survival (OS) [ Time Frame: Up to 5 years ]
OS is defined as the time between enrollment and the patient's death due to any cause.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 3 years ]
Safety includes the adverse event profile of sintilimab and bevacizumab according to the Common Terminology Criteria for Adverse Events version 5.0.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recurrent or persistent ovarian clear cell carcinoma with at least one-line pretreated platinum-containing chemotherapy.
Histologically diagnosis of ovarian clear cell carcinoma. For tumors with mixed histology, at least 70% of the tumors are composed of clear cell carcinoma.
Provide informed consent.
ECOG：0-2.
Aged ≥ 18 years and < 75 years.
Have one or more measurable lesions by RECIST 1.1 criteria.
Expected survival > 12 weeks.
Adequate hematology and organ function

Exclusion Criteria:

Previous administration of immune checkpoint inhibitors, including anti-PD-1/PD-L1/PD-L2 drugs; or anti stimulating/synergistic inhibition of T cell receptor (for example, CTLA-4, OX-40, CD137) drug.
Lack of tumor samples (archived and/or recent obtained).
Patients who have any 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 known to be allergic to the active ingredients or excipients of sintilimab or bevacizumab.
Patients diagnosed of other malignant diseases other than ovarian cancer within 5 years before the first administration.
Patients have an active autoimmune disease that requires systemic treatment within 2 years before the first administration.
Symptomatic or uncontrolled brain metastases that require simultaneous treatment.
Have undergone major surgery (craniotomy, thoracotomy or open surgery) or unhealed wounds, ulcers or fractures within 4 weeks.
Currently participating in interventional clinical trial, or received other research drugs or used research equipment treatment within 4 weeks before the first administration.
Active hemoptysis within 3 months before the first administration.
Patients have been vaccinated with live vaccine within 1 month before the first administration.
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 anti-tumor or immunomodulatory treatment within 2 weeks before the first administration.
Patients are receiving systemic glucocorticoid therapy (not including nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration.
HIV infected (HIV 1/2 antibody positive).
Patients have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis.
Severe unhealed wound ulcers or fractures.
Known allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
Untreated active hepatitis B.
Women patients who are pregnant or breastfeeding, or expect to become pregnant during the study treatment period.
Any severe or uncontrolled systemic diseases.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735861

Contacts

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Contact: Qinglei Gao, PhD, MD	+86-13871127473	qingleigao@hotmail.com

Locations

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China, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Recruiting
Wuhan, Hubei, China, 430030
Contact: Qinglei Gao, PhD, MD +86-13871127473 qingleigao@hotmail.com
Principal Investigator: Qinglei Gao, PhD, MD

Sponsors and Collaborators

Tongji Hospital