Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Rectal Neoplasms

Breast Neoplasms

Nasopharyngeal Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Melanoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

Microsatellite Instability

Squamous Cell Carcinoma of Head and Neck

Mesothelioma

Mesothelioma, Malignant

Nasopharyngeal Carcinoma

Skin Neoplasms

Thymoma

Thymus Neoplasms

Adenocarcinoma, Clear Cell

Melanoma, Cutaneous Malignant

Kidney Neoplasms

Anus Neoplasms

Adenomyoepithelioma

Colorectal Neoplasms

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 Diseases

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Breast Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anus Diseases

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genomic Instability

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Lymphatic Diseases

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Anal Cancer

Epithelial-myoepithelial Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Antibodies

Pembrolizumab

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Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cola

1-cycle KFA115 run-in followed by addition of pembrolizumab

KFA115 + pembrolizumab combination given concurrently

KFA115

pembrolizumab

Novartis Pharmaceuticals

Justin Gainor

Amy Ciriaco

Kristen Spencer

Aric Fellers

Jason Luke

Katie Robbins

Melissa Johnson

The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.

This is a phase I, open-label, multi-center study of KFA115 as a single agent and in combination with pembrolizumab. The study consists of a dose escalation part, followed by dose expansion part(s) for single-agent KFA115 and KFA115 in combination with pembrolizumab. The escalation parts will characterize safety and tolerability. After the determination of the maximum tolerated dose (MTD) / recommended dose (RD), the dose expansion parts will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at MTD/RD.

A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

A DLT is defined as an adverse event or abnormal laboratory value that occurs during the DLT evaluation period where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications and meets the criteria defined in the study protocol

Incidence and severity of adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs

Number of dose interruptions of KFA115 and pembrolizumab, and number of dose reductions of KFA115

Dose intensity of KFA115 and pembrolizumab is defined as the ratio of actual cumulative dose received and actual duration of exposure

BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence

PFS is defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause

DOR is defined as the time from the date of the first documented response (CR or PR) to the date of the first documented progression as per RECIST v1.1 or death due to underlying cancer

TTP is defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to underlying cancer

The maximum (peak) observed plasma or serum drug concentration after single dose administration

The minimum observed plasma or serum drug concentration reached during the time interval between two dose administrations

The time to reach maximum (peak) plasma or serum drug concentration after single dose administration

The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers	NCT05544929	Carcinoma, Non-... Cutaneous Melan... Carcinoma, Rena... Carcinoma, Ovar... Nasopharyngeal ... Carcinoma, Thym... Anal Cancer Mesothelioma Esophagogastric... High Microsatel... Squamous Cell C... Triple Negative...	KFA115 pembrolizumab	18 Years -	Novartis
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers	NCT05544929	Carcinoma, Non-... Cutaneous Melan... Carcinoma, Rena... Carcinoma, Ovar... Nasopharyngeal ... Carcinoma, Thym... Anal Cancer Mesothelioma Esophagogastric... High Microsatel... Squamous Cell C... Triple Negative...	KFA115 pembrolizumab	18 Years -	Novartis

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