What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, particularly those involving immune checkpoint inhibitors like Pembrolizumab, can cause side effects such as fatigue, rash, diarrhea, and severe immune-mediated adverse effects including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Investigational drugs like KFA115 may have a range of side effects that are still being studied, but they often include similar immune-related adverse events and general chemotherapy-related side effects such as nausea, vomiting, and myelosuppression.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for various cancers, including ovarian cancer, particularly in cases with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). Other FDA-approved treatments for ovarian cancer include platinum-based chemotherapies (e.g., carboplatin and cisplatin), PARP inhibitors (e.g., olaparib, niraparib, and rucaparib), and bevacizumab, an angiogenesis inhibitor. These treatments have shown efficacy in different subsets of ovarian cancer patients, often based on genetic markers and disease progression.

What other types of research exist?

Promising alternatives to KFA115 and Pembrolizumab for ovarian cancer patients include: 1) Olaparib, a PARP inhibitor, either alone or in combination with Cediranib, as shown in the NRG-GY004 trial. 2) Avelumab, a PD-L1 inhibitor, which has shown durable responses in clinical trials. 3) Nivolumab, another PD-1 inhibitor, which has been evaluated in various studies for its efficacy in ovarian cancer.

← Back to Search

Other

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.

Must not have

Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.

Any evidence of interstitial lung disease (ILD) or pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, KFA115, alone and with pembrolizumab in patients with advanced cancers. It aims to find the safest dose and see if the drugs can reduce tumors. The focus is on patients whose cancers are hard to treat with current options.

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.

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.

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

Select...

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

Select...

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

Select...

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

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can stop taking medications that affect my heart's rhythm for the study.

Select...

I have never had lung inflammation or similar lung issues that needed strong steroids.

Select...

I have nerve pain or tingling that affects my daily activities.

Select...

I stopped anti-PD-(L)1 therapy because of its side effects.

Select...

I have heart problems that affect my daily activities.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose intensity

Frequency of dose interruptions, reductions

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

+2 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5890

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include investigational agents like KFA115, which likely target specific cancer pathways, and Pembrolizumab, a PD-1 inhibitor that blocks the PD-1 pathway to enhance immune system detection of cancer cells. Platinum-based chemotherapies, such as carboplatin, cause DNA damage in cancer cells, while angiogenesis inhibitors like bevacizumab inhibit blood vessel formation to starve tumors. These mechanisms are vital for ovarian cancer patients as they provide diverse strategies to target and eliminate cancer cells, potentially improving treatment efficacy and patient survival.

Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.