Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

ipilimumab and nivolumab once every 3 weeks for up to 4 doses, followed by nivolumab once every 2 weeks or every 4 weeks until disease progression.

The dose of hypofractionated radiation therapy (HFRT) will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.

The dose of HFRT will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.

Hypofractionated Radiation Therapy (HFRT)

Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses. After these 4 doses, the patient and investigator will decide to continue with nivolumab (240 mg) every 2 weeks or Nivolumab (480mg) every 4 weeks as monotherapy for up to one year as an IV infusion over 30 minutes.

Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses.

Tara Mitchell, MD

Krista Budzik, BSN, RN, OCN

Shanthi Sivendran, MD

Kaitlin Stephens, MBA

The main purpose of this study is to determine the safety of combining ipilimumab and nivolumab with hypofractionated radiotherapy to a single tumor in patients with metastatic melanoma. Another purpose of this study is to determine the effect of ipilimumab, nivolumab and hypofractionated radiotherapy on the cancer as compared to ipilimumab and nivolumab.

Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma

A Randomized Phase 2 Trial of Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma

National Cancer Institute (NCI)

Abramson Cancer Center at Penn Medicine

Symptoms and General Pathology

Glioblastoma

Glioma

Death

Astrocytoma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Avelumab

Immunomodulating Agents

* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Avelumab 10 mg/kg intravenously (IV) every 2 weeks

Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Hypofractionated radiation therapy (HFRT)

Sylvia Kurz, MD

The purpose of this study is to test how safe and effective treatment with the combination of Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma after chemotherapy.

The active pharmaceutical ingredient in Avelumab (MSB0010718C) is a fully human antibody of the immunoglobulin gamma-1 (IgG1) isotype that specifically targets and blocks the Programmed death-ligand 1(PD-L1) for Programmed cell death protein 1 (PD-1).

Avelumab binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on anti-tumor cluster of differentiation 8 (CD8)+ T cells, resulting in the restoration of cytotoxic T cell response.

Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma

A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma

Subjects are evaluable for DLTs (defined in section 5.2.1.2) if they have received at least one dose of Avelumab, have completed HFRT per protocol and have completed safety assessments over the entire DLT evaluation period (days 1 through 28).

PFS, defined as the time between treatment initiation and first occurrence of disease progression or death, will be censored at last follow-up if the patient remained alive without disease progression

OS will be determined from the time of treatment initiation until the time of death, with OS being censored at last follow-up if the patient remained alive

EMD Serono

NYU Langone Health

* Avelumab 10 mg/kg intravenously (IV) every 2 weeks.
* Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Avelumab: Avelumab 10 mg/kg intravenously (IV) every 2 weeks

Hypofractionated radiation therapy (HFRT): Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma	NCT03646617	Metastatic Mela...	Hypofractionate... Nivolumab Ipilimumab	18 Years -	Abramson Cancer Center at Penn Medicine
Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma	NCT02968940	Glioblastoma	Avelumab Hypofractionate...	18 Years -	NYU Langone Health
Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma	NCT02968940	Glioblastoma	Avelumab Hypofractionate...	18 Years -	NYU Langone Health

Spots Global Cancer Trial Database for hypofractionated radiation therapy (hfrt)