A Phase 1 interventional study of KFA115 and pembrolizumab in Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma and Carcinoma, Renal Cell, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 19 sites in 12 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 126 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
KFA115 monotherapy
Drug: KFA115
1-cycle KFA115 run-in followed by addition of pembrolizumab
Drug: KFA115 · Drug: pembrolizumab
KFA115 + pembrolizumab combination given concurrently
Drug: KFA115 · Drug: pembrolizumab
Immunomodulatory agent
Also known as: NVP-KFA115
Anti-PD-1 antibody
Also known as: Keytruda
Incidence and severity of dose limiting toxicities (DLTs) during the DLT evaluation period of single-agent KFA115 (dose escalation only)
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
Time frame: 28 days
Incidence and severity of dose limiting toxicities (DLTs) during the DLT evaluation period of KFA115 in combination with pembrolizumab (dose escalation only)
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
Time frame: 28 days
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs
Time frame: 35 months
Frequency of dose interruptions, reductions
Number of dose interruptions of KFA115 and pembrolizumab, and number of dose reductions of KFA115
Time frame: 35 months
Dose intensity
Dose intensity of KFA115 and pembrolizumab is defined as the ratio of actual cumulative dose received and actual duration of exposure
Time frame: 35 months
Best overall response (BOR) per RECIST v1.1
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Time frame: 35 months
Progression free survival (PFS) per RECIST v1.1
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
Time frame: 35 months
Duration of response (DOR) per RECIST v1.1
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
Time frame: 35 months
Time to progression (TTP) per RECIST v1.1
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
Time frame: 35 months
Area under the concentration time curve (AUC) of KFA115 or pembrolizumab
Area under the concentration time curve
Time frame: During the first 168 days of treatment for single-agent KFA115 and 35 months for KFA115 in combination with pembrolizumab
Peak plasma or serum concentration (Cmax) of KFA115 or pembrolizumab
The maximum (peak) observed plasma or serum drug concentration after single dose administration
Time frame: During the first 168 days of treatment for single-agent KFA115 and 35 months for KFA115 in combination with pembrolizumab
Minimum plasma or serum concentration (Cmin) of KFA115 or pembrolizumab
The minimum observed plasma or serum drug concentration reached during the time interval between two dose administrations
Time frame: During the first 168 days of treatment for single-agent KFA115 and 35 months for KFA115 in combination with pembrolizumab
Time to reach peak plasma or serum concentration (Tmax) of KFA115 or pembrolizumab
The time to reach maximum (peak) plasma or serum drug concentration after single dose administration
Time frame: During the first 168 days of treatment for single-agent KFA115 and 35 months for KFA115 in combination with pembrolizumab
Elimination half-life (T1/2) of KFA115 or pembrolizumab
The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve
Time frame: During the first 168 days of treatment for single-agent KFA115 and 35 months for KFA115 in combination with pembrolizumab
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Novartis Pharmaceuticals