Neoadjuvant PD-1 in Newly Diagnosed Glioblastoma

NCT04583020 | Unknown Phase 2

• 1 other identifier: HS-2522
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the safety and efficacy of Camrelizumab treating patients with newly diagnosed glioblastomas.

Conditions

Glioblastoma

Keywords

Camrelizumab

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  Survival will be assessed at 6 months and 12 months from the time of recruitment until the time of death. Kaplan-Meier survival analyses will be performed.

  up to 12 months

• Progression-free survival (PFS)

  Progression-free survival will be assessed at 6 months and 12 months from the time of recruitment until the time of death. Kaplan-Meier survival analyses will be performed.

  up to 12 months

Secondary Outcomes (2)

• Proportion of participants with treatment-related adverse events

  up to 2 years

• Objective response rate (ORR)

  up to 2 years

Study Arms (1)

Neoadjuvant PD-1 inhibitor

EXPERIMENTAL

Neoadjuvant PD-1 inhibitor Camrelizumab will be administered to patients with newly diagnosed glioblastomas, followed by surgical resection, standard radiochemotherapy, and further PD-1 inhibitor treatment.

Drug: Camrelizumab; Radiation: radiation; Drug: Temozolomide

Interventions

Camrelizumab DRUG

Neoadjuvant Camrelizumab 200mg IV, adjuvant Camrelizumab 200mg IV (once every two weeks, until progress)

Neoadjuvant PD-1 inhibitor

radiation RADIATION

60Gy/30

Neoadjuvant PD-1 inhibitor

Temozolomide DRUG

Given PO during RT 75mg/m2/d; 4 weeks post RT 150-200mg/m2/d days 1-5, 4 weeks/cycle, 6 cycles

Also known as: TMZ

Neoadjuvant PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be willing to provide informed consent.
• Patient must be 18-70 years old.
• Patient must be first diagnosed of WHO grade IV neural glioma by MRI, without previous treatment.
• Patient must receive confine operation that can be delayed for at least 2 weeks, in order to receive neoadjuvant treatment; patient must not receive other antitumor therapy besides this study plan.
• Karnofsky ≥ 70
• If patient is on glucocorticoids treatment, the amount of glucocorticoids must be stable or decreasing at least 5 days before baseline MRI acquisition. Oral dexamethasone must be \<3 tablets(0.75mg/tablet) at least 5 days before baseline MRI.
• Estimate survival ≥12weeks.
• Major organ functions normally, without severe blood, heart, lung, liver, renal abnormality or immune deficiency. Laboratory examination meets the following requirements:
• i. Complete blood count:
• HGB≥90g/L;
• WBC≥3.0×109/L, NEUT≥1.5×109/L;
• PLT ≥60×109/L;
• ii. Blood biochemistry:
• BIL≤1.5×upper limit of normal (ULN);
• ALT and AST≤2.0×ULN;

You may not qualify if:

• Patient with other malignant tumor history in five years (except complete treatment of cervical cancer in situ, basal cell carcinoma, squamous cell skin cancer).
• Patient needs emergency surgery.
• History of allergy to other monoclonal antibody or other ingredients; or can not receive MRI.
• Previous immunotherapy (e.g. PD-1, PD-L1, CTLA-4), previous intracranial radiotherapy.
• Any previous investigational medication within 4 weeks before first administration of Camrelizumab.
• Included in another clinical investigation simultaneously, except for observational (non-interventional) clinical study or follow-up of an interventional clinical study.
• Already has meningioma, multiple gliomas, extracranial lesions. The definition of multiple gliomas is: discontinuous strong signal on T2/FLAIR; satellite lesions.
• History of antitumor vaccine injection, or history of live vaccine injection within 4 weeks before first administration of Camrelizumab.
• Less than 4 weeks after the latest surgery, radiochemotherapy, glucocorticoids treatment, immunotherapy, targeted therapy.
• Any unstable systematic disease (including active infection, uncontrolled hypertension, unstable angina, medical treatment needed liver, kidney, metabolic disease).
• Heart failure with NYHA grade 2 or above, unstable angina, myocardial infarction within 1 year, treatment needed supraventricular or ventricular arrhythmia.
• Patient with known HIV infection or active hepatitis.
• History or risk of autoimmune disease, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, glomerulonephritis. Patient is allowed to be included, if eczema, psoriasis or leukoderma is well controlled at baseline, with only local weak steroid treatment.
• Systematic immune suppressor, such as prednisone, cyclophosphamide, amethopterin, azathioprim, thalidomide, anti-TNF drugs. Low dose of systematic immune suppressor is allowed (e.g. single dose of dexamethasone for nausea). Patient with postural hypotension or adrenocortical insufficiency is allowed to use inhaled corticosteroids and mineralocorticoid.
• History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonia, tissue pneumonia, or evidence of active pneumonia on CT scan. Radiation pneumonia or pulmonary fibrosis is allowed in patient with radiation history.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

camrelizumab; Radiation; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yu Wang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang, MD

CONTACT

861069152530; ywang@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Neoadjuvant PD-1 inhibitor will be administered to patients with newly diagnosed glioblastomas, followed by surgical resection, standard radiochemotherapy, and further PD-1 inhibitor treatment

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 12, 2020
• Study Start: November 12, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)