Trial Title:
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
NCT ID:
NCT05544929
Condition:
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
Conditions: Official terms:
Carcinoma
Neoplasms
Melanoma
Carcinoma, Squamous Cell
Nasopharyngeal Carcinoma
Mesothelioma
Mesothelioma, Malignant
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Melanoma, Cutaneous Malignant
Anus Neoplasms
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Triple Negative Breast Neoplasms
Carcinoma, Ovarian Epithelial
Thymoma
Microsatellite Instability
Pembrolizumab
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KFA115
Description:
Immunomodulatory agent
Arm group label:
KFA115 + pembrolizumab
Arm group label:
KFA115 run-in (1 cycle) + pembrolizumab
Arm group label:
Single-agent KFA115
Other name:
NVP-KFA115
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
Anti-PD-1 antibody
Arm group label:
KFA115 + pembrolizumab
Arm group label:
KFA115 run-in (1 cycle) + pembrolizumab
Other name:
Keytruda
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- 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.
- 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.
- Ovarian cancer, high-grade serous histology, naïve to anti-PD(L)1 therapy, must have
received one prior systemic therapy in platinum-resistant setting.
- 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.
- 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.
- 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.
- 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.
Exclusion Criteria:
- Impaired cardiac function or clinically significant cardiac disease.
- Use of agents known to prolong the QT interval unless they can be permanently
discontinued for the duration of study.
- History of severe hypersensitivity reactions to any ingredient of study drug(s) and
other mAbs and/or their excipients.
- 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.
- Any evidence of interstitial lung disease (ILD) or pneumonitis, or a prior history
of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
- 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).
- Patients with symptomatic peripheral neuropathy limiting instrumental activities of
daily living.
Other protocol-defined inclusion/exclusion criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital .
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Gainor
Phone:
617-724-4000
Email:
jgainor@partners.org
Investigator:
Last name:
Justin Gainor
Email:
Principal Investigator
Facility:
Name:
NYU School of Medicine Langone Health
Address:
City:
New York
Zip:
10015
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Ciriaco
Phone:
212-731-5662
Email:
amy.ciriaco@nyulangone.org
Investigator:
Last name:
Kristen Spencer
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh MC
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aric Fellers
Phone:
412-623-4897
Email:
fellersaj@upmc.edu
Investigator:
Last name:
Jason Luke
Email:
Principal Investigator
Facility:
Name:
SCRI Oncology Partners Sarah Cannon new location
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Robbins
Email:
Katerina.Robbins@scri.com
Investigator:
Last name:
Melissa Johnson
Email:
Principal Investigator
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Shatin New Territories
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chuo ku
Zip:
104 0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Start date:
October 26, 2022
Completion date:
February 20, 2026
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544929
