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131-I-MIBG Therapy for Refractory Neuroblastoma, Expanded Access Protocol
Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma cells. MIBG is combined with radioactive iodine (131 I) in the laboratory to form a radioactive compound 131 I-MIBG. This radioactive compound delivers radiation specifically to the cancer cells and causes them to die. The purpose of this research protocol provides a mechanism to deliver MIBG therapy when clinically indicated, but also to provide a mechanism to continue to collect efficacy and toxicity data that will be provided. A recent New Approaches to Neuroblastoma Therapy (NANT) phase 2 randomized trial of 131I-MIBG with or without...
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131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults
The researchers are doing this study to provide access to treatment with 131I-omburtamab for children and young adults who have CNS/leptomeningeal neoplasms. 131I-omburtamab is an investigational drug; the FDA has not approved it to treat this cancer or any other disease. However, the agency has granted the drug Breakthrough Therapy Designation for the treatment of neuroblastoma with CNS metastases.
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A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
This Expanded Access Program aims to: 1. Provide access to tebentafusp for mUM patients. 2. Provide access to tebentafusp for patients, who were on the control arm of the randomized controlled Phase II trial (IMCgp100-202) and were unable to crossover during the specified window. 3. Ensure that patients, who are benefiting from tebentafusp treatment while participating in an ongoing Immunocore sponsored clinical study (e.g., IMCgp100-102 or IMCgp100-201), may continue tebentafusp treatment on this Programme once the ongoing trial has met all of its key primary and secondary objectives.
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A Compassionate Use/Expanded Access Protocol Using 131I-MIBG Therapy for Patients With Refractory Neuroblastoma and Metastatic Pheochromocytoma
This is an expanded access protocol/compassionate use single institution study designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher priority. Response rate, toxicity, and time to progression and death will be evaluated.
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An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
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Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAFmutation-positive Metastatic Melanoma
The purpose of this Cohort Treatment Plan is to allow access to trametinib (monotherapy or in combination) and dabrafenib (monotherapy or in combination) for eligible patients diagnosed with metastatic melanoma BRAF mutation-positive.
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Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma
This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.
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Expanded Access Program of Surufatinib
This treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic NETs for whom, in the opinion of their treating physician, other treatment options or surufatinib clinical trials in this indication are unsuitable. This EAP is currently available in the US only.
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Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.
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