Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

MEDI0562 administration (90mg on day 1) followed by surgical resection (day 15)

MEDI0562 administration (30mg on days 1, 3, 5) followed by surgical resection (day 15)

MEDI0562

Brenden Curti, MD

This clinical trial will evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.

This clinical trial is the first to evaluate the safety and feasibility of a humanized OX40 agonist, MEDI0562, in the pre-operative setting for patients with head and neck squamous cell carcinoma or melanoma.

Patients will be randomly assigned to one of two MEDI0562 administration schedules; initially 5 patients will enroll to each cohort. All patients will have a tumor biopsy before administration of MEDI0562 and surgery will be performed on approximately day 15 (+/- 2 days).

There will be a comparison of a surgical specimen to the original biopsy focusing on the composition and immunologic phenotypes of lymphocyte subsets. Although the primary endpoint of this study is immunological, valuable exploratory data on clinical outcomes will also be obtained.

Both the HNSCC and the melanoma patients to be enrolled on this trial are anticipated to have a 50 - 90% probability of recurrence within 5 years after surgery, even with current state-of-the-art post-surgical adjuvant radiation, chemotherapy, or immunotherapy. A recurrence of 25% or less within the 12 months after surgery will be deemed of clinical interest and would inform the design of a larger follow-up study.

Patients will be stratified by tumor type and randomly assigned to a MEDI0562 administration schedule; initially 5 patients will enroll to each of two cohorts.

Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma

Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI0562) Administered Prior to Surgical Resection in Patients With Head and Neck Squamous Cell Carcinoma or Melanoma

The primary objective of this phase Ib clinical trial is to ascertain if there is a difference in immune activation comparing a single dose of MEDI0562 with the equivalent dose divided into a Monday, Wednesday Friday schedule in patients with advanced HNSCC or melanoma. Immune activation will be assessed as a cumulative suppressive index (CSI).

Cancer-related clinical outcomes in patients receiving MEDI0562 will be compared with historical controls for progression free survival.

Cancer-related clinical outcomes in patients receiving MEDI0562 will be compared with historical controls for overall survival.

The safety of MEDI0562 administration in patients with locally advanced HNSCC and melanoma will be monitored using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Surgical complications after MEDI0562 administration will be monitored using the Clavien-Dindo grading system.

Providence Cancer Center, Earle A. Chiles Research Institute

MedImmune LLC

Providence Health & Services

Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.

Medimmune LLC

To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors

This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.

A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.

The ORR is defined as the proportion of subjects with confirmed immune related (ir)CR or confirmed irPR

The endpoints for assessment of PK of MEDI0562 include MEDI0562 concentrations in serum at different timepoints after MEDI0562 administration.

The immunogenicity of MEDI0562 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)

The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphoctye subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers

The DCR is defined as the proportion of subjects with irCR, irPR, or irSD (subjects achieving irSD will be included in the DCR if they maintain irSD for ≥8 weeks)

Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

Progression-free survival will be measured from the start of treatment with MEDI0562 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.

Overall survival will be determined as the time from the start of treatment with MEDI0562 until death due to any cause.

Antineoplastic Agents

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.

The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

This is a Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).

The endpoints for assessment of antitumor activity include Best Overall Response (BOR) and will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include, but are not limited to, maximum observed concentration (Cmax).

The endpoints for assessment of immunogenicity of MEDI0562, durvalumab, and tremelimumab include the number and percentage of subjects who develop detectable anti drug antibodies (ADAs).

The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphocyte populations and assessment of tumor-infiltrating lymphocytes (TILs) in tumor biopsy specimens.

The endpoints for assessment of antitumor activity include disease control and is defined as CR, PR, or SD according to RECIST v1.1

The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the first documentation of OR to the first documentation of disease progression or death due to any cause.

The endpoints for assessment of antitumor activity include progression-free survival (PFS) and is defined as the duration measured from the start of treatment with investigational product to the first documentation of disease progression or death due to any cause

The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the time from the start of treatment with Investigational Product until death due to any cause.

The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include area under the concentration-time curve (AUC).

The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include clearance (CL).

The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include terminal phase half-life (t½).

The endpoints for assessment of antitumor activity include objective response (OR) and is defined as confirmed CR or confirmed PR based on RECIST v1.1

The endpoints for assessment of Time to Response TTR and is defined as the time of first treatment to a subsequently confirmed CR or confirmed PR based on RECIST v1.1

The endpoints for assessment percent change from baseline in target lesion sum of diameters will be calculated at each adequate post baseline disease assessment with recorded measurement for all target lesions defined at baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma	NCT03336606	Head and Neck C... Head and Neck S... Melanoma Cell Cancer, Sq... Carcinoma, Squa...	MEDI0562	18 Years -	Providence Health & Services
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors	NCT02318394	Advanced Solid ...	MEDI0562	18 Years - 99 Years	MedImmune LLC
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma	NCT03336606	Head and Neck C... Head and Neck S... Melanoma Cell Cancer, Sq... Carcinoma, Squa...	MEDI0562	18 Years -	Providence Health & Services
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors	NCT02318394	Advanced Solid ...	MEDI0562	18 Years - 99 Years	MedImmune LLC
A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors	NCT02705482	Select Advanced...	MEDI0562 Tremelimumab Durvalumab	18 Years - 100 Years	MedImmune LLC

Spots Global Cancer Trial Database for medi0562

Every month we try and update this database with for medi0562 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.

Spots Global Cancer Trial Database for medi0562

Every month we try and update this database with for medi0562 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.

Every month we try and update this database with for medi0562 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.