Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Herpes Simplex

Cancer Pain

Pain

Virus Diseases

Pain, Intractable

Neurologic Manifestations

All Drugs and Chemicals

Enkephalins

Intradermal injection of NP2 at doses ranging from 10e7 to 10e9 pfu at the site of pain.

David J Fink, MD

The primary purpose of this study is to examine the safety of NP2 (a nonreplicating HSV-based vector expressing enkephalin) in patients with cancer pain. The secondary purpose is to evaluate efficacy.

Therapeutic HSV-based vectors deliver genes from skin inoculation to sensory neurons to interrupt pain signaling at the spinal level. Side effects may be limited by the focal distribution of vector delivery and preproenkephalin expression. Preproenkephalin is a natural human gene that produces peptides that bind to opioid receptors in the body. The therapeutic being evaluated, NP2, is a replication defective herpes simplex type 1 virus (HSV-1) modified to express the human preproenkephalin gene that has demonstrated efficacy in numerous model of pain, including pain caused by cancer.

Gene Transfer for Cancer Pain

Gene Transfer for Intractable Pain: A Phase I Clinical Trial to Determine the Maximum Tolerable Dose of a Replication-Defective Herpes Simplex Virus Type I (HSV-1) Vector Expressing Human Preproenkephalin (NP2) in Patients With Malignancies

Diamyd Inc

Neoplasms

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

Immunomodulating Agents

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

2 cycles of intradermal ipilimumab 0.5 mg + nivolumab 1 mg every 3 weeks

6 cycles of intradermal ipilimumab 0.5 mg + nivolumab 1 mg every week

2 cycles of intradermal ipilimumab 10 mg + nivolumab 20 mg every 3 weeks

intradermal ipilimumab + nivolumab according to the optimal intradermal regimen plus 2 cycles of intravenous nivolumab 240mg every 3 weeks

Christian Blank, Prof

Fons van den Eertwegh, Prof.

Christian Blank, Prof.

Hilde Jalving, Dr.

Ellen Kapiteijn, Dr.

Astrid van der Veldt, Dr.

Karijn Suijkerbuijk, Prof.

This open label, single country trial will test if local injection of low-dose ipilimumab and nivolumab, is safe and reduces the sentinel node positivity in high-risk stage II melanoma patients.

Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma

Multicenter Phase 1b/2 Trial Testing Neoadjuvant Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma - MARIANE

Feasibility as measured by the adherence to the timelines in the study protocol. A treatment arm will be declared as not feasible if 2/7 or 5/20 patients cannot adhere to the planned time of surgery due to treatment-related adverse events.

Pathological response as assessed by blinded central review, adapted from the INMC criteria, including pCR, near-pCR, or pPR (0-50% residual viable tumor in resection material), or sentinel node negativity for melanoma.

Frequency and duration of all grade and grade 3-5, treatment-related adverse events according to CTCAE 5.0;.

defined as time from randomization to melanoma progression (irresectable stage II or III, or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first;

defined as time between date of surgery (re-excision and SN-procedure) and date of first distant metastasis, treatment-related death or melanoma-related death, whichever occurs first;

defined as time between date of randomization and date of death;

The Netherlands Cancer Institute

Vaccines

Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

HS-110 (viagenpumatucel-L)

Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig

HS-130

Rachel E. Sanborn, MD

This is a phase 1 open-label, single center, dose escalation study to determine a safe and effective maximum tolerated dose of HS-130 in combination with viagenpumatucel-L (HS-110) for adult subjects with advanced solid tumors who are refractory to Standard of Care.

This is an open-label, non-controlled, first-in-human Phase I study of HS-130 and HS-110 in patients with advanced solid tumors refractory to, or ineligible for, Standard of Care.

Seven dose levels will be explored in escalating doses. For each dose level, patients will receive combination HS-130 and HS-110 via intradermal injections once every 14 days. The Dose Limiting Toxicity (DLT) window of observation will include the first 28 days of treatment. In the absence of progressive disease or unacceptable toxicity, patients will continue to receive combination treatment every two weeks until disease progression, death, patient's withdrawal of consent, Investigator decision to discontinue treatment, or intolerable toxicity, whichever occurs first.

A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors

A Phase I, First-in-human, Dose-escalation Study to Evaluate the Safety and Immunologic Response After Administration of HS-130 in Combination With HS-110 (Viagenpumatucel-L) in Patients With Solid Tumors Refractory to Standard Care

Number of Patients with Dose Limiting Toxicity (DLT)

Heat Biologics

Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Patients will receive a combination of intradermal HS-130 and HS-110 once every 14 days. The dose levels will be determined by the starting dose and the escalation steps outlined in the protocol.

HS-110 (viagenpumatucel-L): Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

HS-130: Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig

Cohort 1: HS-130 (150 ng- 600 ng) + HS-110 (150 ng - 300 ng) (Viagenpumatucel-L)

Cohort 2: HS-130 (600 ng) + HS-110 (600 ng) (Viagenpumatucel-L)

Cohort 3: HS-130 (1200 ng) + HS-110 (600 ng) (Viagenpumatucel-L)

Cohort 4: HS-130 (1200 ng) + HS-110 (1200 ng) (Viagenpumatucel-L)

Total

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

United States

Region of Enrollment

Vice President, Clinical Development

The safety population includes all patients who received at least one dose of study drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene Transfer for Cancer Pain	NCT00804076	Cancer Pain	NP2	18 Years -	Diamyd Inc
Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma	NCT06240143	Melanoma	Ipilimumab Nivolumab Nivolumab	18 Years -	The Netherlands Cancer Institute
Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma	NCT06240143	Melanoma	Ipilimumab Nivolumab Nivolumab	18 Years -	The Netherlands Cancer Institute
A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors	NCT04116710	Advanced Solid ...	HS-110 (viagenp... HS-130	18 Years -	Heat Biologics
A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors	NCT04116710	Advanced Solid ...	HS-110 (viagenp... HS-130	18 Years -	Heat Biologics

Spots Global Cancer Trial Database for intradermal

Every month we try and update this database with for intradermal 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 intradermal

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