NCT04735861
Completed
Phase 2
Sintilimab Plus Bevacizumab in Patients With Recurrent/Persistent Ovarian Clear Cell Carcinoma
ConditionsOvarian Clear Cell Carcinoma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Tongji Hospital
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Sintilimab (Drug)
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.
Intervention: Bevacizumab Biosimilar IBI305 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Duration of remission (DOR)(Up to 3 years)
- Overall survival (OS)(Up to 5 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 3 years)
- Progression-free survival (PFS)(Up to 3 years)
- Time to response (TTR)(Up to 2 years)
- Disease control rate (DCR)(Up to 5 years)
- Quality of life assessment of patients(Quality of life will be assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O))
Investigators
Qinglei Gao
Professor
Tongji Hospital
Study Sites (1)
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