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

Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Dose level -1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

CBL0137

Anthony Olszanski, MD

Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma

The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)

Incuron

Fox Chase Cancer Center

Pharmaceutical Solutions

Cadonilimab (AK104) (10 mg/kg, Q3W, administered on the frst day of each cycle, Q3W, until there is no clinical beneft) + anlotinib (8 mg, QD, 2 weeks off for 1 week)

Cadonilimab

anlotinib

Xingxiang Pu, doctor

This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.

Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure

Efficacy and Safety of Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure: A Single-arm, Open-label, Multicenter Phase II Clinical Study

ORR is the proportion of patients with best response of complete response (CR) and PR

Time from the date of frst study treatment administration to the date of first

Proportion of patients whose best overall response is either CR, PR, or SD

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE

Hunan Cancer Hospital

Infections

Symptoms and General Pathology

Adenoviridae Infections

Communicable Diseases

Virus Diseases

DNA Virus Infections

ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.

ICOVIR-5

Ramon Salazar, MD PhD

Ramon Alemany, PhD

The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.

Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma

Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma

Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.

Virus presence in tumors at day 5 post-administration.

The highest dose where less than two out of three or six patients suffered dose limiting toxicity.

Institut Català d'Oncologia

TKI258

Novartis Pharmaceuticals

This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be performed on all subjects. The eligible subject population consists of subjects who have been diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy or for which no curative standard therapy exists.

Safety of TKI258 in Advanced/Metastatic Melanoma Subjects

A Phase I/II Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TKI258 (CHIR-258) in Patients With Locally Advanced or Metastatic Melanoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma	NCT05498792	Locally Advance...	CBL0137 Ipilimumab Nivolumab	18 Years -	Fox Chase Cancer Center
Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure	NCT06327698	Melanoma	Cadonilimab anlotinib	18 Years - 75 Years	Hunan Cancer Hospital
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma	NCT01864759	Locally Advance...	ICOVIR-5	18 Years -	Institut Català d'Oncologia
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma	NCT05498792	Locally Advance...	CBL0137 Ipilimumab Nivolumab	18 Years -	Fox Chase Cancer Center
Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure	NCT06327698	Melanoma	Cadonilimab anlotinib	18 Years - 75 Years	Hunan Cancer Hospital
Safety of TKI258 in Advanced/Metastatic Melanoma Subjects	NCT00303251	Melanoma	TKI258	18 Years -	Novartis

Spots Global Cancer Trial Database for locally advanced or metastatic melanoma