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Cytokine

ALKS 4230 for Solid Tumors

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Awards & highlights

Study Summary

This trial will study the safety of a new drug, ALKS 4230, given by itself and with another drug, pembrolizumab. Researchers will also identify the best dose of ALKS 4230 to use in future trials.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (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
Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type.
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
Number of subjects experiencing AEs that are both serious and drug-related in Part B
Secondary outcome measures
Duration of response in subjects with CR/iCR
Duration of response in subjects with PR/iPR
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
+7 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%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: ALKS 4230 + pembrolizumabExperimental Treatment2 Interventions
ALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230.
Group II: ALKS 4230Experimental Treatment1 Intervention
Administered via SC injection once every 7 days or once every 21 days at escalating doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
ALKS 4230
2016
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

Mural Oncology, IncLead Sponsor
5 Previous Clinical Trials
887 Total Patients Enrolled
Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,700 Total Patients Enrolled
Alkermes Medical DirectorStudy DirectorAlkermes, Inc.
11 Previous Clinical Trials
4,113 Total Patients Enrolled

Frequently Asked Questions

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

Is this study taking place in several hospitals throughout Canada?

"Currently, the trial is being conducted at 21 sites which are situated in cities such as Saint Paul, Hamilton and Edmonton. If you enroll in the study, it would be ideal to choose a location close to you in order reduce travel time and costs."

Answered by AI

Are there any patients still being accepted into this research program?

"Unfortunately, this particular study has already wrapped up recruitment. The posting date was February 26th, 2019 and the most recent edit was on October 4th, 2022. However, there are presently 2584 trials actively admitting participants with solid tumors and advanced solid tumors and 1000 trials for ALKS 4230 that may be of interest."

Answered by AI

ALKS 4230 is a medication used to treat what condition?

"ALKS 4230 provides a treatment option for patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

How many people total will be participating in this experiment?

"Unfortunately, this study is no longer recruiting patients. The listing was created on February 26th, 2019 but the last update was on October 4th, 2022. However, there are 2584 other trials for solid tumors and 1000 studies for ALKS 4230 that are still enrolling patients."

Answered by AI

Are there similar drugs to ALKS 4230 that have been studied before?

"ALKS 4230 was first researched seven years ago at City of Hope. As of now, there have been 249 completed clinical trials and 1000 studies that are still recruiting patients. A large number these open trials are based in Saint Paul, Minnesota."

Answered by AI

What are the investigators of this trial aiming to discover?

"The primary goal for this study, which will be conducted over a period of 24 months, is to evaluate the number of subjects experiencing AEs that are both serious and drug-related in Part B. Secondary outcomes include measuring serum concentrations of proinflammatory cytokines at various time points using a multiplex method, defining results by dose level, duration of response in subjects with PR/iPR, proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR), and ORR based on investigator review of radiographic or photographic images."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)
2019. "A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03861793.
~19 spots leftby Apr 2025
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