Neoplasms

All Conditions

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Antibodies, Monoclonal

Molgramostim

Sargramostim

Immunoglobulins

Ceritinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

5 cycles of standard of care induction + naxitimab

Naxitimab on Days 1, 3, and 5 of each cycle

5 cycles of standard of care induction + naxitimab + ceritinib

Naxitimab on Days 1, 3, and 5 of each cycle Ceritinib once daily on every day of study

Naxitamab is a humanized (IgG1) anti-GD2 (hu3F8) monoclonal antibody for the treatment of neuroblastoma, osteosarcoma and other GD2-positive cancers. Naxitamab was granted accelerated approval by the FDA in 2020 as treatment (in combination with granulocyte-macrophage colony-stimulating factor - GM-CSF) for pediatric patients at least one year of age and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy

Naxitamab

Ceritinib is an inhibitor that selectively targets the ALK tyrosine kinase

Genevieve Bergendahl, MSN

Abigail Moore

Jennifer Ward, MD

Rebecca McFall, MD

Susan Hall

Kevin Bielamowicz, MD

Group Contact

Jennifer Michlitsch, MD

Kimberly Gray

Coleen McDonough, MD

Andrea Siu, MPH

Randal Wada, MD

Jontyce Green, RN

Thomas Russell, MD

Graham Keyes

Sarah Supples, MD

Rhea Robinson, RN

Virginia Harrod, MD

Guillaume Leblanc

Pierre Tiera, MD

Valérie-Ève Julien

Bruno Michon, MD

Jaqueline Kraveka, DO

This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. Subjects with an ALK mutation or amplification will have ceritinib added to their treatment regimen as soon as results are available. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy.

All subjects will be followed for disease response, event free survival, overall survival and toxicity. Extent of disease will be measured and assessed for changes throughout the course of the study. All efficacy analyses will be performed on the evaluable population which will consist of all enrolled subjects (subjects who initiate treatment with naxitamab in combination with GM-CSF plus standard induction therapy) and who have measurable disease at baseline.

The initial chemotherapy Induction regimen will utilize sequential administration of 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles.

Subjects with an activating ALK mutation or ALK amplification will have ceritinib added to their treatment regimen as soon as results are available.

Stem cell mobilization and collection will occur after the 2nd cycle of induction.

Surgical resection of the primary tumor will ideally occur after the 4th cycle of Induction but may be delayed until after the 5th cycle of Induction if medically necessary.

Disease status evaluations will occur at the following time points: (1) pre-treatment, (2) post Cycle 2 Induction (3) Prior to surgical resection (if performed), (4) End of Induction (which includes surgery and 5 cycles of chemotherapy), and (5) End of Additional/Salvage Therapy as needed.

The current standard of care for high-risk neuroblastoma involves 5-7 cycles of induction chemotherapy with surgical removal of the tumor after 4-5 cycles of chemotherapy, followed by high-dose chemotherapy plus autologous stem cell transplant, then radiation to the primary tumor bed, followed by anti-GD2 immunotherapy and cis retinoic acid. This results in a less than 60% disease free survival for high-risk NB, a survival rate that still greatly needs improvement. Two areas in which improvements can be made include: 1) to improve response rate to induction chemotherapy and 2) to improve EFS by improving maintenance therapy to prevent relapse.

We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Narcotic use will be quantified for each subject over the course of the study in terms of morphine equivalent daily dose (MEDD).

Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC) and compare to relevant historical controls.

The proportion of patients with a complete response or partial response to naxitamab with standard induction therapy for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 and 2017 International Neuroblastoma Response Criteria (INRC).Collected by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans and bone marrow response.

The proportion of patients with a complete response or partial response to naxitamab with standard induction therapy for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 and 2017 International Neuroblastoma Response Criteria (INRC). Collected by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans and bone marrow response at the end of 2 cycles.

Overall survival (OS) for subjects receiving the combination of standard Induction chemotherapy with naxitamab.

Progression-free survival (PFS) for subjects receiving the combination of standard Induction chemotherapy with naxitamab.

Response rate of naxitamab in combination with salvage chemotherapy in subjects who have a poor response (as defined as PR/MR/SD/NR) after 5 cycles of induction. Collected by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans and bone marrow response.

Y-mAbs

Giselle Sholler

Beat Childhood Cancer Chair

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Mouth and Tooth Diseases

Carcinoma

Colorectal Neoplasms

Cholangiocarcinoma

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Intestinal Diseases

Brain Neoplasms

Head and Neck Neoplasms

Sarcoma

Carcinoma, Renal Cell

Colonic Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Gastrointestinal Diseases

Neuroendocrine Tumors

Gastrointestinal Neoplasms

Intestinal Neoplasms

Respiratory Tract Diseases

Thoracic Neoplasms

Digestive System Neoplasms

Respiratory Tract Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Salivary Gland Neoplasms

Lymphoma, Large-Cell, Anaplastic

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Connective and Soft Tissue

Endocrine System Diseases

Endocrine Gland Neoplasms

Adenocarcinoma

Rectal Diseases

Pancreatic Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Lung Neoplasms

Bronchial Diseases

Lung Diseases

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Adenocarcinoma, Papillary

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Pancreatic Cancer

Ovarian Cancer

Papillary Thyroid Carcinoma

Bile Duct Cancer

Renal Cell Carcinoma

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Lymphosarcoma

Neuroendocrine Tumor

Oral Cancer

Alectinib

Entrectinib

Participants with locally advanced or metastatic ALK-positive tumors will receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.

Clinical Trials

This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Hoffmann-La Roche

Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

ALK-positive Solid Tumors

The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided.

Age, Continuous

Sex/Gender, Customized

Race/Ethnicity, Customized

Medical Communications

Confirmed ORR was defined as the proportion of participants with a complete or partial response (CR or PR) confirmed at least 28 days after initial response.

Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1

DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1

PFS was defined as the time from the first dose of alectinib to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1

CNS ORR was defined as the objective tumor response rate (CR or PR) of CNS lesions and could not be calculated due to an insufficient number of participants with the event.

Central Nervous System (CNS) ORR by BICR Per RECIST v1.1

CNS DOR was defined as the time from the first observation of CNS response until the first observation of CNS progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

CNS DOR by BICR Per RECIST v1.1

OS was defined as the time from first dose of study drug to death from any cause- and could not be calculated due to an insufficient number of participants with the event.

Overall Survival (OS)

Percentage of Participants With Adverse Events (AEs)

Percentage of Participants With Serious Adverse Events (SAEs)

Plasma concentration data was not collected as the data for one participant was not sufficient.

Plasma Concentration of Alectinib

ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria

DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria

PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma	NCT05489887	High-risk Neuro...	Naxitamab Ceritinib	12 Months - 21 Years	Milton S. Hershey Medical Center
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors	NCT04644315	Neoplasms Colorectal Neop... Melanoma Pancreatic Neop... Sarcoma Ovarian Neoplas... Brain Neoplasms Thyroid Neoplas... Neuroendocrine ... Cholangiocarcin... Salivary Gland ... Head and Neck N... Thyroid Cancer,... Lymphoma, Large... Neoplasms by Si... Respiratory Tra... Thoracic Neopla... Respiratory Tra... Carcinoma, Bron... Bronchial Neopl... Intestinal Neop... Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina... Colonic Disease... Intestinal Dise... Central Nervous...	Alectinib	18 Years -	Hoffmann-La Roche
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.	NCT03792568	Colorectal Canc...	ALK Inhibitor	18 Years - 70 Years	Shanghai Changzheng Hospital
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors	NCT04644315	Neoplasms Colorectal Neop... Melanoma Pancreatic Neop... Sarcoma Ovarian Neoplas... Brain Neoplasms Thyroid Neoplas... Neuroendocrine ... Cholangiocarcin... Salivary Gland ... Head and Neck N... Thyroid Cancer,... Lymphoma, Large... Neoplasms by Si... Respiratory Tra... Thoracic Neopla... Respiratory Tra... Carcinoma, Bron... Bronchial Neopl... Intestinal Neop... Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina... Colonic Disease... Intestinal Dise... Central Nervous...	Alectinib	18 Years -	Hoffmann-La Roche
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma	NCT05489887	High-risk Neuro...	Naxitamab Ceritinib	12 Months - 21 Years	Milton S. Hershey Medical Center
Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)	NCT06234579	ALK Gene Mutati... NSCLC Stage IV ALK Sensitizing...	Biopsy (tissue ...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Spots Global Cancer Trial Database for alk mutation

Every month we try and update this database with for alk mutation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.