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An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas

Study Purpose

IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Glioblastoma.
  • - Glioma Brain.
  • - Male or female subjects aged ≥18 years.
  • - Histopathological evidence of glioblastoma or glioma.
  • - Patients still alive must provide informed consent if required by local regulations - Maximal tumor diameter (including residual tumor and resection cavity if subjects had tumor resection rather than only stereotactic biopsy) up to 7cm or less.
  • - Karnofsky performance status (Appendix 2) of ≥60.
  • - Availability of a paraffin-embedded or frozen tumor-tissue block with a minimum of 0.5 cm2 and 5 unstained slides from the glioblastoma or glioma tissue specimen.
  • - Not earlier than 35 days after surgery.
  • - An interval of at least 2 week for stereotactic biopsy from the start of study treatment.
  • - A contrast-enhanced MRI must be obtained within 7 days of the first dose of study treatment.
  • - Adequate hematologic, hepatic, and renal function defined by test - Women must have a negative serum or urine pregnancy test before 24 hours of initiation of study drug.
  • - Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be defined as post-menopausal. Women receiving ipilimumab will be instructed to adhere to contraception for a period of 35 weeks after the last dose of program.
  • - Men receiving ipilimumab and who are sexually active will be instructed to adhere to contraception for a period of 39 weeks after the last dose of program.
  • - Contraception is not required for men with documented vasectomy.
  • - Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
  • - Women must not be breastfeeding.
  • - Willing to and capable of providing written informed consent prior to any program related procedures.
  • - Ability and willingness to comply scheduled visits, treatment plans, laboratory tests, and other program-related procedures.

Exclusion Criteria:

  • - Prior systemic treatment anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  • - Planned participation in another study intended for therapy of glioma or glioblastoma.
  • - Primary brainstem or spinal cord tumor.
  • - Diffuse leptomeningeal gliomatosis.
  • - Сonfirmed mutation of the IDH1/2 genes.
  • - Stem or dendritic cell therapy 60 days before the program or 45 days after the last infusion of ipilimumab.
  • - Systemic treatment with either immunosuppressive doses of corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 21 days of study drug administration.
  • - Patients on a standard high-dose steroid taper after craniotomy or stereotactic biopsy may have received a higher dose of corticosteroids within 21 days of registration, however must be at a dose < 5 mg daily prednisone or bioequivalent per day within 7 days prior to initiation of study drug.
  • - Patients requiring adrenal replacement with corticosteroids are eligible if the steroids are at doses ≤ 10 mg prednisone or bioequivalent per day in the absence of active autoimmune disease.
  • - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are allowed.
  • - Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
  • - Prior organ transplantation, including allogeneic stem cell transplantation.
  • - Known history of, or any evidence of active, non-infectious pneumonitis within the last 5 years.
  • - Known severe (NCI-CTCAE v4.03 Grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
  • - Unable tolerate an MRI, or have a contraindication to MRI.
  • - Active infection requiring systemic therapy.
  • - Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
  • - Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) indicating acute or chronic infection.
  • - Vaccination within 5 weeks of the first dose of study drug and while on trials is prohibited except for administration of inactivated vaccines.
ATTENTION: Seasonal influenza vaccines for injection are live attenuated vaccines, and are not allowed.
  • - Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ NY Heart Association - CC II), or serious cardiac arrhythmia requiring medication.
  • - All other unstable, severe, or chronic medical or psychiatric conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, recent (within the past year) or active suicidal idea in behavior, or laboratory abnormalities that may increase the risk associated with program or judgment of the investigator, would make the patient participation impossible.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03460782
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Center Trials & Treatment
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Available
Countries Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Romania, Russian Federation, Serbia, Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Glioma of Brain
Additional Details

It is not yet known which protocols are a better treatment for glioblastoma or glioma. The ipilimumab extended-access program for patients who received previous chemotherapy and / or radiation therapy by protocol, before ((for non-operable cases) or after the operation. Monoclonal antibodies of CTLA-4, such as ipilimumab, may block tumor growth in different ways by targeting certain cells and activating the patient's immune system to fight the disease.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tirana, Albania

Status

Address

University "Mother Theresa" Hospital Center; Oncology Department

Tirana, , 1000

Banja Luka, Bosnia and Herzegovina

Status

Address

University Clinical Center of the Republic of Srpska

Banja Luka, , 78000

Complex Oncology Center, Plovdiv, Bulgaria

Status

Address

Complex Oncology Center

Plovdiv, , 4004

Osijek, Croatia

Status

Address

Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

Osijek, , 31000

Bucharest,, Romania

Status

Address

Institut of Oncology Al. Trestioreanu Bucharest; Oncology

Bucharest,, , 022338

Regional Oncology Hospital, Irkutsk, Russian Federation

Status

Address

Regional Oncology Hospital

Irkutsk, , 664035

Rostov Cancer Research Institute, Rostov-on-Don, Russian Federation

Status

Address

Rostov Cancer Research Institute

Rostov-on-Don, , 344037

Primorsky Regional Oncology Center, Vladivostok, Russian Federation

Status

Address

Primorsky Regional Oncology Center

Vladivostok, , 690069

Belgrade, Serbia

Status

Address

Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

Belgrade, , 11 000

Inselspital Bern; Medizinische Onkologie, Bern, Switzerland

Status

Address

Inselspital Bern; Medizinische Onkologie

Bern, , 3010

Stadtspital Triemli; Frauenklinik, Zürich, Switzerland

Status

Address

Stadtspital Triemli; Frauenklinik

Zürich, , 8063