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KFA115 + Tislelizumab for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, naive to anti-PD(L)1 therapy, and must have received one prior systemic therapy in platinum-resistant setting.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 months

Awards & highlights

Study Summary

This trial tests the safety and side effects of two drugs for advanced cancers, to find the safest and most effective dose.

Who is the study for?

This trial is for adults with certain advanced cancers like renal cell carcinoma, ovarian cancer, melanoma, and non-small cell lung cancer. Participants must have tried some treatments already and meet specific medical history criteria. They should weigh over 36 kg and be able to undergo a tumor biopsy.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of KFA115 alone or combined with tislelizumab in treating select advanced cancers. It aims to find the highest dose patients can tolerate without severe side effects.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to ingredients in the drugs, nerve pain that affects daily activities, heart issues due to prolonged QT interval from other medications, autoimmune disease flare-ups or new occurrences, lung problems like ILD or pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have melanoma that worsened after anti-PD(L)1 therapy and, if BRAF V600 mutant, was also treated with a BRAF inhibitor.

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I have high-grade serous ovarian cancer, haven't had anti-PD(L)1 therapy, and had one treatment after becoming platinum-resistant.

Select...

My lung cancer responded to previous immunotherapy for at least 4 months and I've had platinum-based chemotherapy.

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I have a specific type of advanced cancer and haven't received anti-PD(L)1 therapy.

Select...

I am willing and able to have a biopsy as per my hospital's rules.

Select...

I weigh more than 36 kg.

Select...

I have clear cell renal cancer, treated with anti-PD(L)1 and VEGF therapies, and my disease has progressed.

Select...

My cancer is advanced nasopharyngeal, not treated with anti-PD(L)1 before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose intensity

Frequency of dose interruptions, reductions

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

+2 more

Secondary outcome measures

Area under the concentration time curve (AUC) of KFA115 or pembrolizumab

Best overall response (BOR) per RECIST v1.1

Duration of response (DOR) per RECIST v1.1

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Single-agent KFA115Experimental Treatment1 Intervention

KFA115 monotherapy

Group II: KFA115 run-in (1 cycle) + pembrolizumabExperimental Treatment2 Interventions

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

Group III: KFA115 + pembrolizumabExperimental Treatment2 Interventions

KFA115 + pembrolizumab combination given concurrently

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5750

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,173 Total Patients Enrolled

Media Library

KFA115 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05544929 — Phase 1

Esophageal Cancer Research Study Groups: KFA115 + pembrolizumab, Single-agent KFA115, KFA115 run-in (1 cycle) + pembrolizumab

Esophageal Cancer Clinical Trial 2023: KFA115 Highlights & Side Effects. Trial Name: NCT05544929 — Phase 1

KFA115 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05544929 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential adverse effects could arise from single-agent KFA115?

"Due to the limited data available from Phase 1 clinical trials, Single-agent KFA115 garnered a safety rating of 1 on our team's scale."

Answered by AI

Are there still vacancies available to participate in this experiment?

"Clinicaltrials.gov has confirmed that this medical trail is actively seeking patients, the listing having been created on October 26th 2022 and last updated on May 8th of 2023."

Answered by AI

Is this medical study being conducted in various parts of the United States?

"At present, 5 centres are actively enrolling participants for this trial; with locations in Toronto, Shatin New Territories and Shatin. To reduce the time spent commuting if you become part of the study it is advised to choose a centre closest to your residence."

Answered by AI

How many participants are eligible to partake in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the study is still enlisting participants and commenced on October 26th 2022. It was last modified on May 8th 2023 with a total of 220 patients being accepted from 5 medical sites."

Answered by AI

What results are researchers hoping to achieve through this clinical trial?

"As specified by the trial sponsor, Novartis Pharmaceuticals, primary outcomes will be ascertained over a period of 28 days. Specifically, they are gaugeing incidents and levels dose limiting toxicities (DLTs) during their evaluation phase alongside immunogenicity when tislelizumab is administered in combination with KFA115. Secondary objectives encompass determining those that develop anti-drug antibodies (ADA), duration of response per RECIST v1.1 definition from first documented response to first observed progression or death due to underlying cancer, and best overall recordable responses according to RECIST v1.1 specifications."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05544929.

All > Non Small Cell Lung Cancer > Thymic Carcinoma