What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly immunotherapy drugs like PD-1/PD-L1 inhibitors (e.g., pembrolizumab, nivolumab) and CTLA-4 inhibitors (e.g., ipilimumab), are associated with immune-related adverse events (irAEs). These can include fatigue, rash, diarrhea, and endocrinopathies such as thyroid dysfunction. Severe irAEs may involve pneumonitis, hepatitis, colitis, and myocarditis. Chemotherapy, often used in combination with immunotherapy, can cause nausea, vomiting, hair loss, and myelosuppression, leading to increased infection risk. Targeted therapies may result in specific side effects depending on the target, such as hypertension with VEGF inhibitors or skin rash with EGFR inhibitors.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of solid tumors. Pembrolizumab, an anti-PD-1 antibody, is approved for various cancers including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma. Nivolumab, another anti-PD-1 antibody, is approved for melanoma, NSCLC, and renal cell carcinoma, often in combination with ipilimumab, an anti-CTLA-4 antibody. These drugs work by modulating the immune response to target the tumor microenvironment, enhancing the body's ability to fight cancer.

What other types of research exist?

Promising novel alternatives to immunotherapy for solid tumors in 2024 include: 1) Targeted therapies such as tyrosine kinase inhibitors (TKIs) and monoclonal antibodies that target specific genetic mutations or pathways in cancer cells. 2) Combination therapies that pair traditional chemotherapy or radiation with newer agents to enhance efficacy. 3) Novel drug classes like antibody-drug conjugates (ADCs) and bispecific T-cell engagers (BiTEs) that offer targeted delivery of cytotoxic agents to cancer cells. 4) Personalized medicine approaches, including the use of genetic profiling to tailor treatments to individual patient tumor profiles.

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Cytokine

Nemvaleukin Alfa + Pembrolizumab for Cancer (ARTISTRY-3 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Mural Oncology, Inc

Eligibility Criteria Checklist

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

Must have

All patients' baseline biopsies must be taken no more than 3 months before Screening and at least 4 weeks after completion of last antineoplastic therapy

Patient must have received 1 to 3 prior FDA-approved targeted therapies, failure of adjuvant and neoadjuvant therapy is considered 1 line of treatment

Must not have

Patients who have received prior IL-2-based or IL-15-based soluble protein therapy at any time in the past are excluded

Patients with active or symptomatic central nervous system metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial involves two ways of treating patients with tumors. One method focuses on the tumor environment, and the other uses a different dosing schedule. The goal is to see which method works better.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including melanoma, lung cancer, and ovarian cancer. Participants must have had 1-3 prior treatments fail or be intolerable. They should have a measurable tumor and good blood, liver, and kidney function. Prior immunotherapy is allowed under specific conditions but no recent steroids or other disqualifying treatments.

What is being tested?

The study tests Nemvaleukin alfa alone or with Pembrolizumab in two groups: one focusing on how the drug affects the tumor environment (single-center), and another on less frequent IV dosing of the drugs (multi-center). It aims to see if these approaches are effective against various solid tumors.

What are the potential side effects?

Potential side effects may include immune-related reactions due to Pembrolizumab such as skin issues, colitis, hepatitis; infusion reactions from Nemvaleukin alfa; fatigue; nausea; increased risk of infections; and possibly others based on individual patient response.

Eligibility Criteria

Inclusion Criteria

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

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My last cancer treatment was over 4 weeks ago, and my biopsy was done within the last 3 months.

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I've had 1-3 prior treatments for my condition, including any before or after surgery.

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I have a confirmed diagnosis of a specific advanced cancer type and at least one tumor that can be biopsied.

Exclusion Criteria

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

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I have never received IL-2 or IL-15 protein therapy.

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I have active brain metastases.

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I have a history of HIV or hepatitis B/C or currently test positive for them.

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I take more than 10 mg of prednisone daily or its equivalent.

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I have not had radiotherapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 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

Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells)

Secondary study objectives

Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells)

Changes in absolute numbers of circulating leukocytes

Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on treatment

+2 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

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: Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and PembrolizumabExperimental Treatment2 Interventions

This arm will not open for enrollment.

Group II: Cohort 2 Part A: Less Frequent IV Dosing NemvaleukinExperimental Treatment1 Intervention

Group III: Cohort 1: Tumor Microenvironment (TME) Nemvaleukin and PembrolizumabExperimental Treatment2 Interventions

Nemvaleukin will be administered via Intravenous (IV) infusion given daily for 5 consecutive days followed by an off-treatment period. Starting on Cycle 3, Day 1 of each cycle, Pembrolizumab will be administered via IV infusion followed by IV infusion of nemvaleukin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 8Eligibility 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

Immune checkpoint inhibitors, such as PD-1/PD-L1 and CTLA-4 inhibitors, enhance the immune system's ability to recognize and destroy tumor cells by blocking proteins that prevent T-cells from attacking cancer cells. This targeted approach is crucial for solid tumor patients as it can lead to more effective and durable responses compared to traditional therapies. Ongoing research into modulating the tumor microenvironment aims to further improve these immune responses, potentially leading to more personalized and effective treatments.