RECRUITING

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

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Conditions

Carcinoma, Non-Small-Cell LungCutaneous MelanomaCarcinoma, Renal CellCarcinoma, Ovarian EpithelialNasopharyngeal CarcinomaCarcinoma, ThymicAnal CancerMesotheliomaEsophagogastric CancerHigh Microsatellite Instability Colorectal CarcinomaSquamous Cell Carcinoma of Head and NeckTriple Negative Breast NeoplasmsLung cancerNon-small-cell lung cancerNSCLCMalignant Skin CancerSkin CancerRenal cell carcinomaRCCKidney cancerRenal cancerClear cell carcinomaCancer of the ovariesFemale reproductive cancerOvarian carcinomaEpithelial ovarian cancerNasopharyngeal NeoplasmsNPCThymic carcinomaThymic tumorRectal cancerRectal neoplasmsEsophageal cancerCancer of throatColon cancerColorectal cancerBowel cancerCancer of the colon and rectumCRCMSI-H CRCAdvanced solid malignanciesHead and neck cancerHNSCCSCCHNSquamous cell carcinoma of the head and neckCancerAdvanced cancerNVP-KFA115Triple Negative Breast CancerTNBC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-26
Study Completion:2026-02-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05544929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Non-small cell lung cancer with historic PD-L1 ≥ 1%, as determined locally using a clinically accepted assay. Patients must have experienced benefit from previous anti-PD(L)1-containing therapy for at least 4 months based on investigator-assessed disease stability or response prior to developing documented disease progression. Patients must have also received prior platinum-based chemotherapy, either in combination or in sequence with anti-PD-(L)1, unless patient was ineligible to receive such treatment.
  2. * Renal cell carcinoma, clear cell histology, previously treated with anti-PD(L)1-containing therapy and a VEGF targeted therapy as monotherapy or in combination. Patients should have documented disease progression following anti-PD(L)1-containing therapy.
  3. * Cutaneous melanoma, previously treated with anti-PD(L)1-containing therapy. Patients should have documented disease progression following anti-PD(L)1-containing therapy. Patients with BRAF V600-mutant melanoma must have also received prior therapy with a BRAF V600 inhibitor, with or without a MEK inhibitor.
  4. * Ovarian cancer, high-grade serous histology, naïve to anti-PD(L)1 therapy, must have received one prior systemic therapy in platinum-resistant setting.
  5. * Nasopharyngeal carcinoma, non-keratinizing locally advanced recurrent or metastatic. Depending on the study arm, patients may be naïve to anti-PD(L)1 therapy, or previously treated with platinum-based chemotherapy with or without anti-PD-(L)1.
  6. * Locally advanced unresectable or metastatic triple negative breast cancer, ovarian cancer (high-grade serous histology), anal cancer (squamous), MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC.
  7. * Locally advanced unresectable or metastatic anal cancer (squamous), thymic carcinoma, MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC, all naïve to anti-PD(L)1 therapy and for whom anti PD(L)1 therapy is not available.
  8. * Triple negative breast cancer with historic PD-L1 CPS ≥ 1%, must have received at least one line of chemotherapy. In addition, these patients must have previously received sacituzumab govitecan, and in the case of a BRCA mutation a PARP inhibitor, if these treatments are locally approved and accessible to the patient.
  1. * Impaired cardiac function or clinically significant cardiac disease.
  2. * Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.
  3. * History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
  4. * Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur may be considered. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
  5. * Any evidence of interstitial lung disease (ILD) or pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
  6. * Patients who discontinued prior anti-PD-(L)1 therapy due to an anti-PD-(L)1-related toxicity (applicable to the KFA115 in combination with pembrolizumab treatment arms).
  7. * Patients with symptomatic peripheral neuropathy limiting instrumental activities of daily living.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Massachusetts General Hospital .
Boston, Massachusetts, 02114
United States
NYU School of Medicine
New York, New York, 10015
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-26
Study Completion Date2026-02-20

Study Record Updates

Study Start Date2022-10-26
Study Completion Date2026-02-20

Terms related to this study

Keywords Provided by Researchers

  • Lung cancer
  • Non-small-cell lung cancer
  • NSCLC
  • Malignant Skin Cancer
  • Skin Cancer
  • Cutaneous melanoma
  • Renal cell carcinoma
  • RCC
  • Kidney cancer
  • Renal cancer
  • Clear cell carcinoma
  • Cancer of the ovaries
  • Female reproductive cancer
  • Ovarian carcinoma
  • Epithelial ovarian cancer
  • Nasopharyngeal Neoplasms
  • Nasopharyngeal carcinoma
  • NPC
  • Thymic carcinoma
  • Thymic tumor
  • Rectal cancer
  • Rectal neoplasms
  • Esophageal cancer
  • Cancer of throat
  • Colon cancer
  • Colorectal cancer
  • Bowel cancer
  • Cancer of the colon and rectum
  • High microsatellite instability colorectal carcinoma
  • CRC
  • MSI-H CRC
  • Advanced solid malignancies
  • Head and neck cancer
  • HNSCC
  • SCCHN
  • Squamous cell carcinoma of the head and neck
  • Cancer
  • Advanced cancer
  • NVP-KFA115
  • Triple Negative Breast Cancer
  • TNBC
  • Mesothelioma
  • Anal cancer

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Cutaneous Melanoma
  • Carcinoma, Renal Cell
  • Carcinoma, Ovarian Epithelial
  • Nasopharyngeal Carcinoma
  • Carcinoma, Thymic
  • Anal Cancer
  • Mesothelioma
  • Esophagogastric Cancer
  • High Microsatellite Instability Colorectal Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Neoplasms