Phase 2 Study to Evaluate the Clinical Efficacy and Safety of Sintilimab Plus Low-dose Bevacizumab in Patients With Oligodendroglioma of Different Relapse Stages

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an ongoing Phase 2, open-label, single-center, non-randomized study of sintilimab (one anti-PD-1 antibody same as nivolumab approved in China) plus bevacizumab administered in a low dosage schedule in adult (≥ 18 years) participants with a clinical relapse or circulating tumor DNA (ctDNA)-level relapse of Oligodendroglioma(WHO III). This study has three non-comparative study groups. Cohort 1 and Cohort 2 will receive the same study drug sintilimab 200mg and bevacizumab 3mg/kg every 3 weeks. Cohort 3 will take only standard treatment. A stringent three-step non-randomized process will be used to assign participants to one of the study groups. Neither participants nor doctors but the researcher can choose which group participants are in. No one knows if one study group is better or worse than the other. 80 total participants are expected to participate in this study (30 participants in Cohort 1 and Cohort 2). Grouping process: After enrollment, under the standard of care, participants will receive regular tumor in situ fluid (fluid within the surgical cavity, TISF) sampling for ctDNA analysis and recceive regular MRI. The researcher will study the TISF ctDNA and imaging dynamics to determine whether the tumor reaches to ctDNA-level (Cohort 1) or clinical relapse (Cohort 2). At the first step, all timely identified as ctDNA-level relapse tumors will be assigned into the Cohort 1 and receive the study drug immediately, those failed to be timely identified will be assigned into the Cohort 2 and receive the study drug after the clinical relapse. At the second step, once Cohort 1 or Cohort 2 reaches the target number, the new participants will be all assigned into the other Cohort. In the third step, if no CTDNA-level or clinical relapse was observed within 60 months after surgery, patients were assigned to Cohort 3 and further analyzed for prognostic biomarkers compared with Cohort 1 and Cohort 2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations

• Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by MRI and tumor in situ fluid (TISF) collection

• Histologically confirmed diagnosis of oligodendroglioma(WHO III)

• Resection surgery done at the study center (Henan Provincial People's Hospital), with an reservoir intraoperatively implanted connecting the surgical cavity and the subscalp for postoperative noninvasive TISF collection

• An interval of \> 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to grouping

• Karnofsky performance status (KPS) of 70 or higher

• Life expectancy \> 12 weeks

Locations
Other Locations
China
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Xingyao Bu, MD, PhD
xingyaob@zzu.edu.cn
+86037165580295
Time Frame
Start Date: 2022-12-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Experimental: Cohort 1
Subjects with ctDNA-level-relapse Oligodendroglioma before clinical relapse, determined according to the dynamics of TISF ctDNA.
Experimental: Cohort 2
Subjects with clinical-relapse Oligodendroglioma, determined according to the response assessment in neuro-oncology (RANO) criteria for gliomas.
No_intervention: Cohort 3
Subjects without ctDNA-level-relapse and clinical-relapse Oligodendroglioma.
Sponsors
Leads: Henan Provincial People's Hospital

This content was sourced from clinicaltrials.gov