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Cytokine

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

Phase 1 & 2
Recruiting
Research Sponsored by Mural Oncology, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential (WOCBP) must have a negative pregnancy test
Patients must have adequate hematologic reserve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first dose of study drug to the end of study (estimated up to 24 months)
Awards & highlights

ARTISTRY-3 Trial Summary

This trial will have 2 groups of people who will be studied. One group will be studied at one center and the other group will be studied at multiple centers.

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.Check my eligibility
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.See study design
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.

ARTISTRY-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and my pregnancy test is negative.
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My blood counts are within a healthy range.
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My liver and kidneys are working well.
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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 waited at least 4 weeks after my last anti-PD-1 therapy before getting a screening biopsy.
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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've had immunotherapy without severe side effects or had to stop due to them.
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I have a confirmed diagnosis of a specific advanced cancer type and at least one tumor that can be biopsied.
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I have a specific type of cancer and treatments have not worked or caused intolerance.

ARTISTRY-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first dose of study drug to the end of study (estimated up to 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose of study drug to the end of study (estimated up to 24 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
Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells)
Biopsy
Incidence of dose-limiting toxicity (DLT)
Secondary outcome measures
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
+8 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

ARTISTRY-3 Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and PembrolizumabExperimental Treatment2 Interventions
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 2
~2010

Find a Location

Who is running the clinical trial?

Mural Oncology, IncLead Sponsor
5 Previous Clinical Trials
925 Total Patients Enrolled
Alkermes, Inc.Lead Sponsor
113 Previous Clinical Trials
26,658 Total Patients Enrolled
Sonali PanchabhaiStudy DirectorMural Oncology

Media Library

Nemvaleukin alfa (ALKS 4230) (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04592653 — Phase 1 & 2
Solid Tumors Research Study Groups: Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and Pembrolizumab, Cohort 1: Tumor Microenvironment (TME) Nemvaleukin and Pembrolizumab, Cohort 2 Part A: Less Frequent IV Dosing Nemvaleukin
Solid Tumors Clinical Trial 2023: Nemvaleukin alfa (ALKS 4230) Highlights & Side Effects. Trial Name: NCT04592653 — Phase 1 & 2
Nemvaleukin alfa (ALKS 4230) (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592653 — Phase 1 & 2

Frequently Asked Questions

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

In which areas are the trials of this clinical research taking place?

"This research initiative is ongoing in 4 different healthcare facilities, which are situated in Houston, West Valley City and Grand Rapids. To reduce travel costs for participants, it's vital to choose the site nearest you."

Answered by AI

What is the current patient count for this clinical trial?

"Affirmative. The clinical trial is currently seeking enrollees, with the original list published on September 30th 2020 and last updated August 30th 2022. In total, 78 participants will be recruited from 4 different locales."

Answered by AI

Are there any opportunities presently available to participate in this research?

"Affirmative, according to clinicaltrials.gov this research is currently recruiting participants. Initially posted on September 30th 2020 and edited most recently on August 30th 2022, the trial aims to include 78 patients from 4 distinct health facilities."

Answered by AI

For which medical conditions is the prescription Pembrolizumab typically prescribed?

"Pembrolizumab is used to combat cancerous growths, including unresectable melanoma and microsatellite instability high. It has also been shown effective for patients with chemotherapy-resistant disease progression."

Answered by AI

Has Pembrolizumab been trialed in the past for any medical purposes?

"Initially studied at City of Hope, pembrolizumab has been researched in a total of 251 trials. At present, 961 studies are underway with numerous of these investigations being conducted in Houston, Texas."

Answered by AI
~5 spots leftby Jul 2024