Neoplasms

All Conditions

Rare Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Bevacizumab

Tislelizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Subjects with ctDNA-level-relapse Astrocytoma before clinical relapse, determined according to the dynamics of TISF ctDNA.

Subjects with clinical-relapse Astrocytoma, determined according to the response assessment in neuro-oncology (RANO) criteria for gliomas.

Subjects without ctDNA-level-relapse and clinical-relapse Astrocytoma.

200mg sintilimab plus 3mg/kg bevacizumab every 3 weeks.

Tislelizumab plus Bevacizumab

Xingyao Bu

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 Astrocytoma. 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. 70 total participants are expected to participate in this study (25 participants in Cohort 1 and Cohort 2,20 participants in Cohort 3).

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.

Primary study objectives:

-To evaluate the clinical efficacy as measured by the overall survival (OS) rate at 24 months (Cohort 2) and OS rate at 36 months (Cohort 1).

Secondary study objectives:

* To evaluate the safety/tolerability of the study treatment; To compare the OS, progression-free survival and overall response rate of the two study groups. Exploratory objectives:
* To evaluate the correlative biomarkers based on TISF ctDNA.

Standard of care:

-Surgical removal of tumors followed by adjuvant temozolomide (150-200 mg/m2, days 1-5 every 28 days for up to 12 cycles). The decision to extend TMZ treatment beyond 6 cycles, for up to 12 cycles, was left to the treating investigator. Patients were asked to attend follow-up visits every 3 months after the end of chemotherapy.

Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Astrocytoma

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

OS-24 is the proportion of participants in the analysis population who remain alive for at least 24 months following initiation of study therapy.

OS-36 is the proportion of participants in the analysis population who remain alive for at least 36 months following initiation of study therapy.

The proportion of participants in the analysis population who remain progression-free for at least 18 months following initiation of study therapy.

overall survival, as defined as time from beginning of treatment to death.

Proportion of participants in the analysis population who have complete response (CR) or partial response (PR) using RANO criteria.

Participants without efficacy evalaluation data or survival data censored at day 1. Participants without measurable disease will not be included.

Median time from allocation to first documented disease progression as per RANO or death due to any cause, whichever occurs first.

Time from first RANO response to disease progression in participants who achieve a PR or better.

Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of durvalumab. AEs are considered to be treatment emergent if they occur or worsen in severity after the first dose of study treatment.

Henan Provincial People's Hospital

Oligodendroglioma

Subjects with ctDNA-level-relapse Oligodendroglioma before clinical relapse, determined according to the dynamics of TISF ctDNA.

Subjects with clinical-relapse Oligodendroglioma, determined according to the response assessment in neuro-oncology (RANO) criteria for gliomas.

Subjects without ctDNA-level-relapse and clinical-relapse Oligodendroglioma.

Xingyao Bu, MD, PhD

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.

Primary study objectives:

-To evaluate the clinical efficacy as measured by the overall survival (OS) rate at 30 months (Cohort 2) and OS rate at 36 months (Cohort 1).

Secondary study objectives:

* To evaluate the safety/tolerability of the study treatment; To compare the OS, progression-free survival and overall response rate of the two study groups. Exploratory objectives:
* To evaluate the correlative biomarkers based on TISF ctDNA.

Standard of care:

-Surgical removal of tumors followed by adjuvant temozolomide (150-200 mg/m2, days 1-5 every 28 days for up to 12 cycles). The decision to extend TMZ treatment beyond 6 cycles, for up to 12 cycles, was left to the treating investigator. Patients were asked to attend follow-up visits every 3 months after the end of chemotherapy.

Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Oligodendroglioma

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

OS-30 is the proportion of participants in the analysis population who remain alive for at least thirty months following initiation of study therapy.

OS-36 is the proportion of participants in the analysis population who remain alive for at least thirty-six months following initiation of study therapy.

The proportion of participants in the analysis population who remain progression-free for at least fifteen months following initiation of study therapy.

Symptoms and General Pathology

Recurrence

Glioblastoma

Disease Attributes

Patients with bevacizumab-refractory recurrent glioma with PTEN or TERT gene mutations,determined according to the dynamics of TISF (Tumor in Situ Fluid) ctDNA.

Patients with bevacizumab-refractory recurrent glioma without PTEN or TERT gene mutations,determined according to the dynamics of TISF (Tumor in Situ Fluid) ctDNA.

200mg Tislelizumab plus 3mg/kg bevacizumab every 3 weeks

The purpose of this study is to evaluate the clinical efficacy and safety of Tislelizumab (one anti-PD-1 antibody same as nivolumab approved in China) in combination with bevacizumab in patients with recurrent or progressive glioblastoma (GBM) who have progressed on bevacizumab with or without PTEN or TERT gene mutations.

Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma

Phase 2 Study to Evaluate the Clinical Efficacy and Safety of Tislelizumab Plus Low-dose Bevacizumab in Bevacizumab Refractory Recurrent Glioblastoma With PTEN or TERT Gene Mutations

Proportion of participants in the analysis population who have complete response (CR) or partial response (PR) using RANO criteria. Participants without efficacy evalaluation data or survival data censored at day 1. Participants without measurable disease will not be included.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Astrocytoma	NCT05518994	Astrocytoma of ...	Tislelizumab pl...	18 Years -	Henan Provincial People's Hospital
Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Oligodendroglioma	NCT05512351	Oligodendroglio...	Tislelizumab pl...	18 Years -	Henan Provincial People's Hospital
Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma	NCT05540275	Recurrent Gliob...	Tislelizumab pl...	18 Years -	Henan Provincial People's Hospital

Spots Global Cancer Trial Database for tislelizumab plus bevacizumab