What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) and Melanoma that are similar to NIZ985, spartalizumab, and tislelizumab include immune checkpoint inhibitors like nivolumab, pembrolizumab, and ipilimumab. The known side effects of these treatments often include fatigue, diarrhea, rash, and decreased appetite. More severe side effects can include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These side effects are generally manageable but require close monitoring and sometimes necessitate discontinuation of therapy.

What prior FDA approvals exist?

For Non-Small Cell Lung Cancer (NSCLC), the FDA has approved several PD-1 and PD-L1 inhibitors, including atezolizumab and cemiplimab. Atezolizumab has shown improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Cemiplimab, another PD-1 inhibitor, has also demonstrated significant improvements in OS and PFS in patients with high PD-L1 expression. For Melanoma, the FDA has approved nivolumab and ipilimumab, both of which are immune checkpoint inhibitors. Nivolumab targets PD-1, while ipilimumab targets CTLA-4. These drugs have been used both as monotherapies and in combination, showing enhanced efficacy in treating advanced melanoma.

What other types of research exist?

For Non-Small Cell Lung Cancer (NSCLC) and Melanoma patients, promising novel alternatives to NIZ985 include: <ol> <li>Pembrolizumab (Keytruda): An immune checkpoint inhibitor that has shown efficacy as monotherapy and in combination with other agents in various cancers, including NSCLC and Melanoma.</li> <li>Nivolumab (Opdivo) and Ipilimumab (Yervoy): This combination has demonstrated significant benefits in advanced Melanoma and NSCLC.</li> <li>Atezolizumab (Tecentriq) plus Bevacizumab (Avastin): This combination has shown efficacy in metastatic renal cell carcinoma and may be considered for other cancers.</li> <li>Enfortumab Vedotin: A novel antibody-drug conjugate that has shown promise in urothelial carcinoma and may be explored for other solid tumors.</li> <li>Ibrutinib: Although primarily used in hematologic malignancies, it has shown potential in solid tumors with specific mutations, such as MYD88 in Marginal Zone Lymphoma.</li> </ol>

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NIZ985 + Spartalizumab for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, NIZ985, alone and with two other drugs, in patients with advanced cancers that have worsened after previous treatments. The treatment works by enhancing the immune system's ability to fight cancer.

Who is the study for?

This trial is for adults with advanced solid tumors or lymphoma, including melanoma and non-small cell lung cancer (NSCLC), who've had standard treatments fail. They should be in good physical condition, have measurable disease, and be able to follow the study rules. People can't join if they're on high-dose steroids, have other active cancers or serious heart conditions, recently received certain therapies or live vaccines, are pregnant/nursing, or have severe allergies to study drug ingredients.

What is being tested?

The trial is testing NIZ985 alone and combined with Spartalizumab or Tislelizumab to find safe doses and schedules. It aims to understand how these drugs affect the body (pharmacokinetics) and their preliminary effects on tumor growth.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, immune system-related issues affecting various organs due to increased activity of white blood cells (IL-15 stimulation), fatigue, nausea, as well as risks associated with biopsies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Dose interruptions and reductions

Incidence of Dose Limiting Toxcities (DLTs) in escalation and expansion

+1 more

Secondary study objectives

Best Overall Response (BOR)

Disease control Rate (DCR)

Duration of Response (DOR) (expansion groups only)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment3 Interventions

Combination arm. NIZ985 and Spartalizumab combination is administered starting at Cycle 1 Day 1 in dose escalation. NIZ985 and tislelizumab combination is administered starting at Cycle 1 Day 1 in dose expansion.

Group II: Arm 1Experimental Treatment2 Interventions

Single agent arm. NIZ985 is administered as a single agent (subjects may be treated with the NIZ985-Spartalizumab combination after their first disease re-evaluation)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spartalizumab

2017

Completed Phase 3

~850

Tislelizumab

2018

Completed Phase 3

~4560

Do I qualify?Apply below to find out

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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) and Melanoma include immune checkpoint inhibitors like PD-1, PD-L1, and CTLA-4 inhibitors. These treatments, such as spartalizumab and tislelizumab, work by blocking proteins that suppress the immune system, thereby enhancing the body's ability to attack cancer cells. This mechanism is crucial for NSCLC and Melanoma patients as it helps the immune system recognize and destroy cancer cells that typically evade immune detection, potentially leading to improved tumor control and survival rates.

Chemotherapy for advanced non-small cell lung cancer in the elderly population.Chemotherapy for advanced non-small cell lung cancer in the elderly population.