Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Rare Diseases

Melanoma

Uveal Neoplasms

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

Eye Neoplasms

Uveal Diseases

Ocular Melanoma

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Nivolumab

Pembrolizumab

Ipilimumab

Dacarbazine

Crizotinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.

Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.

Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.

IDE196

IV administration every 3 weeks for 4 Cycles

IV administration every 3 Weeks for 4 Cycles, thereafter every 4 Weeks maintenance

IDEAYA Clinical Trials

Darrin Beaupre, MD, Ph.D

Oncology Clinical Trials Nurse Navigator

Katie O'Neil, BA

Jazelle Molina

Adyel Annelus

Elizabeth Seja

Saba Mukarram

Denise Fortun

CPMC Clinical Research Group

Sonia Contreras Martinez, BSN

Sarah Mayer, BA

Victoria Mayer, VA

SCRI Front Desk

Nikhil Khushalani, MD

Leticia Tetteh, BSN

Central Research Department

Asad Javed, MD

Kamaneh Montazeri, MD

Rizwan Haq

Linnea Drew

The Cancer and Hematology Centers

Jessica Miller, RN

Amer Alyasiry, MHS

Tyler Klein

Benjamin Switzer, DO

igor Puzanov, MD

Richard Carvajal, MD

Tracy Green, BS

Alexander Shoushtari, MD

James Smithy, MD

Carol Ann Wiggs, BSN

Emily Bolch

Lucy Kennedy, MD

Marlana Orloff

Kristie Hensel

Amy Rose, RN,BSN

Jennifer Cleric, ND, RN

Sanjay Chandrasekaran, MD

Desiree Pierre, BS

Sapna Patel, MD

Matteo Carlino, MD

Janine Thomas

Joanne Tonkin

Rose McDowell

Roberts-Thomson, MD

Jean Francois Baurain, MD

John Walker, MD,PhD,FRCPC

Marcus Butler

Rahima Jamal, MD

Chantal Gosselin

Eve-Marie Neidhardt, MD

Sophie Piperno-Neumann, MD

Jessica Hassel, Prof. Dr. med

Halime Kalkavan, Dr. med

Nicole Kreuzberg, MD

Friedegund Meier, Prof. Dr. med

Caroline Anna Peuker, MD

Jonathan Cohen, MD

Annaelle Dynovisz, SC

Ronnie Shapira, MD

Lorenza DiGuardo, MD

Paolo Ascierto, MD

Ernesto Rossi, MD

Michele Maio, MD

Ellen Kapiteijn, MD

Josep Maria Piulats, MD

Yolanda Alvarez, BSc

Estiban Mendez, Bsc

María del Carmen Álamo, MD

María Candón, SC

Alfonso Berrocal, MD

Iris Ramos

Reinhard Dummer, Prof. Dr. med

Ruth Orr

Joseph Sacco, Professor

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

This study is designed as a multi-stage Phase 2 study within a Phase 3 study to evaluate the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor activity of IDE196 in combination with crizotinib compared to the comparator arm of investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

The Phase 2a dose optimization stage will evaluate two doses of IDE196 in combination with crizotinib compared to the comparator arm. Participants will be randomized to the three treatment arms. At the point of optimal IDE196 + crizotinib dose selection, the other dose arm will be dropped with discontinuation of enrollment to that arm. Participants receiving the IDE196 dose (in combination with crizotinib) that is not selected, will be offered the choice to remain on the same dose or change to the chosen optimal dose.

The optimal dose will be chosen to complete the Phase 2b portion. The Phase 2b part of the study will continue to enroll the chosen combination dose of IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to the two treatment arms.

The Phase 3 part of the study will continue to enroll the chosen combination dose of IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to the two treatment arms.

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)

OS from randomization to date of death due to any cause

Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs as measured by CTCAE V5.0

Dose-exposure-response of IDE196 as measured by concentration of IDE196 in plasma

Dose-exposure-response of Crizotinib as measured by concentration of Crizotinib in plasma

Global health status and quality of life will be assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.

General health status will be assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.

IDEAYA Biosciences

Diseases and Abnormalities at or Before Birth

Infections

Symptoms and General Pathology

Congenital Abnormalities

Papilloma

Abscess

Eyelid Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Central Nervous System Depressants

Anti-Arrhythmia Agents

Channel Blockers

Vasoconstrictor Agents

Respiratory System Agents

Anesthetics

Lidocaine

Epinephrine

Anesthetics, Local

Racepinephrine

Epinephryl borate

Sodium Channel Blockers

Diuretics, Potassium Sparing

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic corresponding to the study arm (0.9% bacteriostatic saline or 1% lidocaine with 1:100,000 epinephrine). Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.

0.9% Bacteriostatic Local Anesthetic Injection

Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic consisting of a commercially available mixture of 1% lidocaine with 1:100,000 epinephrine. Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.

1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection

Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon.

Eyelid Lesion Removal

Robert Kersten, MD

The investigators aim to assess whether bacteriostatic saline provides the same level of anesthesia as traditional local anesthesia while reducing pain associated with medication infusion in minor eyelid procedures

Benzoyl alcohol is an aromatic alcohol that has been used in healthcare primarily as an antibacterial preservative agent in bacteriostatic saline. It has also been shown to have anesthetic properties, and has been demonstrated to cause less pain with infusion compared to lidocaine, while maintaining adequate pain relief. The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the periocular area has not yet been studied. The purpose of this study was to determine whether bacteriostatic saline provides an adequate level of anesthesia for minor in-office eyelid procedures while allowing for reducing pain associated with medication infusion compared with traditional local anesthetic agents. To assess this, the investigators will recruit 150 patients aged 18 or older undergoing minor eyelid procedures including eyelid biopsies, chalazion removal from outpatient oculoplastics clinics at UCSF. Patients will be randomized in a 1:1 fashion to undergo local anesthetic with either 1% lidocaine with 1:100,000 epinephrine or 0.9% bacteriostatic saline. Primary outcome measure will be pain level on a scale of 1-10 with regards to injection and procedure itself. These will be compared between the two groups. The investigators hypothesize that bacteriostatic saline is superior to lidocaine with epinephrine in terms of pain with injection, but will result in a similar pain level during the procedure.

Patient and provider performing procedure will be masked to local anesthesia type

Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

Pain on a scale of 0-10 during injection process (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after injection.

Pain on a scale of 0-10 during procedure (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after procedure.

Need for additional anesthesia to complete procedure

Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.

University of California, San Francisco

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.

Blenrep

Thomas W LeBlanc, MD

The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI) clinics.

Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma	NCT05987332	Metastatic Uvea...	IDE196 Crizotinib Pembrolizumab Ipilimumab Nivolumab Dacarbazine	18 Years -	IDEAYA Biosciences
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures	NCT05294640	Eyelid Tumor Eyelid Bump Eyelid Deformit... Eyelid Abscess Eyelid Boil Eyelid Papillom... Anesthesia, Loc... Ophthalmology	0.9% Bacteriost... 1% Lidocaine wi... Eyelid Lesion R...	18 Years - 110 Years	University of California, San Francisco
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures	NCT05294640	Eyelid Tumor Eyelid Bump Eyelid Deformit... Eyelid Abscess Eyelid Boil Eyelid Papillom... Anesthesia, Loc... Ophthalmology	0.9% Bacteriost... 1% Lidocaine wi... Eyelid Lesion R...	18 Years - 110 Years	University of California, San Francisco
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma	NCT05986682	Multiple Myelom...	Blenrep	18 Years - 89 Years	Duke University
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma	NCT05907954	Uveal Melanoma	Darovasertib	18 Years -	IDEAYA Biosciences
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma	NCT05907954	Uveal Melanoma	Darovasertib	18 Years -	IDEAYA Biosciences
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions	NCT03947385	Metastatic Uvea... Cutaneous Melan... Colorectal Canc... Other Solid Tum...	IDE196 Binimetinib Crizotinib	18 Years -	IDEAYA Biosciences

Spots Global Cancer Trial Database for ophthalmology