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

Launched by NOVARTIS PHARMACEUTICALS · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of a new treatment called KFA115, both on its own and in combination with another medication called pembrolizumab, for patients with certain types of advanced cancers. The goal is to find out how well these treatments work and to determine the highest dose that can be safely given to patients. The study is currently recruiting participants and is open to adults aged 65 and older with specific types of cancers, including non-small cell lung cancer, melanoma, renal cell carcinoma, ovarian cancer, and several others.

To be eligible, patients must have had prior treatments that included anti-PD(L)1 therapy and meet certain medical criteria, such as having documented disease progression after those treatments. Participants will receive close monitoring for safety and may benefit from access to new therapies that are not yet widely available. It’s important to note that individuals with certain health conditions, such as severe heart problems or autoimmune diseases, may not be eligible to join the study. Overall, this trial offers hope for patients looking for new treatment options for advanced cancer.

Gender

ALL

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